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Faria, C., Li, X., Nagl, N., & McBride, A. (2014). Outcomes associated with 5-HT3-RA therapy selection in patients with chemotherapy-induced nausea and vomiting: A retrospective claims analysis. American Health and Drug Benefits, 7, 50–58.

Study Purpose

To evaluate the clinical and economic impact of delayed chemotherapy-induced nausea and vomiting (CINV) on patients who received initial and maintenance therapy with the 5-hydroxytryptamine 3 (5HT3) receptor antagonist palonosetron compared to older agents

Intervention Characteristics/Basic Study Process

There was no intervention in this retrospective study; however, the procedure was outlined. Using the OptumInsight® database, researchers evaluated the impact of 5HT3 on chemotherapy-naïve patients. This database provided information on all pharmacy and medical claims for each subject, and records were accessed six months prior to the initial chemotherapy treatment and six months after. Patients were not evaluated if the type of antiemetic changed or if chemotherapy was changed. ICD9 codes and pharmacy charges were monitored for primary or secondary diagnoses of nausea, vomiting, and dehydration. Economic outcomes also were evaluated and calculated.

Sample Characteristics

  • N = 26,974
  • AVERAGE AGE = 55.7 years
  • MALES: 30.9%, FEMALES: 69.1%
  • KEY DISEASE CHARACTERISTICS: Patients who were chemotherapy-naïve; not receiving multiday chemotherapy; 53% breast; 20% lung; remainder split between ovarian, colon, and other cancers
  • OTHER KEY SAMPLE CHARACTERISTICS: 72% of patients had a diagnosis for a single site.

Setting

  • SITE: Not stated
  • SETTING TYPE: Not specified  
  •  LOCATION: OptumInsight database

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care and palliative care

Study Design

Retrospective database analysis

Measurement Instruments/Methods

No instruments were used, but information extracted from the database included patient and treatment characteristics, nausea, vomiting, Charlson Comorbidity Index scores, antiemetic therapy, and specific 5HT3 use.

Results

Preindex comorbidity scores were lowest in the palonosetron group and highest in the dolasetron group. The overall rate for delayed CINV at cycle 1 was 15.6% for all groups. When compared to palonosetron, patients who received ondansetron (p < 0.002), granisetron (p < 0.001), and dolasetron (p = 0.002) had higher rates of CINV in the second and subsequent cycles of chemotherapy. Dexamethasone was consistently used in the first cycle for all treatment groups. Aprepitant was used most often in the palonosetron group (10.7%) compared to ondansetron (3.6%), granisetron (2.3%), and dolasetron (2.5%).

Conclusions

5HT3 agents were effective in preventing CINV. There were differences in 5HT3 efficacy and cost. Delayed CINV rates increased with subsequent cycles of older 5HT3 agents. Palonosetron showed improvement over time. Similar trends were seen with healthcare resource use.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias(sample characteristics)
  • Key sample group differences that could influence results
  • Measurement/methods not well described 
  • Other limitations/explanation: Comorbidities were lowest in the palonosetron group. The palonosetron group received aprepitant more often than the other groups. This may have influenced the outcome measures. This was a claims analysis, and cases of delayed CINV may not have been captured, especially when patients were given a supply of antiemetics to use at home. This study only included patients who were commercially insured. It did not capture any complementary methods that may have been used (i.e., acupressure, nutraceutical).

Nursing Implications

This study demonstrated cost effectiveness. Medical costs constituted the largest costs. Costs were higher if a patient experienced CINV. Nurses need to use guidelines and risk factors when starting patients on chemotherapy. Using a 5HT3 agent based on the emetogenic potential of chemotherapy is important.

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Fares, K.M., Mohamed, S.A., Abd El-Rahman, A.M., Mohamed, A.A., & Amin, A.T. (2015). Efficacy and safety of intraperitoneal dexmedetomidine with bupivacaine in laparoscopic colorectal cancer surgery, a randomized trial. Pain Medicine, 16, 1186–1194. 

Study Purpose

To investigate the safety and efficacy of intraperitoneal bupivacaine and dexmedetomidine in patients undergoing laparascopic colorectal surgery for postoperative pain management

Intervention Characteristics/Basic Study Process

Patients were randomized to one of three groups: (a) control (intraperitoneal injection of saline), (b) bupivacaine only (125 mg, 0.25%) injection, and (c) combined dexmedetomidine and bupivacaine (bupivacaine 0.25% and 1 mcg/kg dexmedetomidine). After hemostasis was achieved in surgery, intraperitoneal instillation of study drugs was sprayed uniformly into the periotoneal cavity guided by camera. Pain was assessed at baseline and at 2, 3, 6, 8, 12, and 24 hours postoperatively. IV tramadol (100 mg) was given when pain was at least 3 or upon patient request.

Sample Characteristics

  • N = 45   
  • MEAN AGE = 50 years 
  • MALES: 53.3%, FEMALES: 45.6%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: All had colorectal cancer and were undergoing laparascopic surgical procedures. Most were undergoing hemicolectomy. Others had anterior resections.
  • OTHER KEY SAMPLE CHARACTERISTICS: No differences existed between groups in duration of surgery.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Egypt

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Double-blind, placebo-controlled, three-group, randomized trial

Measurement Instruments/Methods

  • Visual analog scale (VAS) for pain severity
  • Observer's Assessment of Alertness/Sedation Scale (OAA/S)

Results

The group that received bupivacaine and dexmedetomidine had significantly lower pain at 2, 4, and 24 hours compared to the other study groups (p < 0.03) and needed rescue analgesic much later (p = 0.0002). No difference in time to analgesia existed between study groups 1 and 2. Average overall postoperative tramadol consumption was lower in the group receiving the combined intraperitoneal analgesia (p = 0.001).

Conclusions

Intraperitoneal administration of bupivacaine and dexmedetomidine improved the effectiveness and duration of postoperative analgesia compared to bupivacaine alone or placebo.

Limitations

  • Small sample (< 100)

 

Nursing Implications

Findings showed that loco-regional analgesic administration after laparoscopic colorectal surgery was effective for postoperative analgesia, and the addition of dexmedetomidine to bupivacaine improved efficacy and duration of analgesic effect.

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Fares, K.M., Mohamed, S.A., & Abdel-Ghaffar, H.S. (2014). High dose intrathecal morphine for major abdominal cancer surgery: A prospective double-blind, dose-finding clinical study. Pain Physician, 17, 255–264.

Study Purpose

To investigate the safety and efficacy of three doses of intrathecal morphine in patients receiving major abdominal surgery

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive 0.2 mg, 0.5 mg, or 1 mg of morphine injected into the L3-4 space prior to anesthesia. All patients received the same type of anesthesia and reversal. Vital signs and Visual Analog Scales for pain were assessed at six, 12, 18, 24, 36, 48, and 72 hours postoperatively. At patient request, or for a pain score greater than or equal to 3, rescue analgesia of 100 mg IV tramadol was given.

Sample Characteristics

  • N = 90  
  • MEAN AGE = 50.45 years (range = 35–64 years)
  • MALES: Not provided  
  • FEMALES: Not provided
  • KEY DISEASE CHARACTERISTICS: Patients had surgeries including pelvic excentration, hemicolectomy, sigmoidectomy, cystectomy, and hysterectomy. The majority of procedures were American Society of Anesthesiologists class 2.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient    
  • LOCATION: Egypt

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Double-blinded, randomized trial

Measurement Instruments/Methods

  • Time till first analgesic request
  • Total analgesic consumption
  • Observers Assessment of Alertness/Sedation (OAA/S)
  • Postoperative adverse effects
  • Visual Analog Scale (VAS)

Results

The mean time in hours till the first analgesic request was longer in those receiving 0.5 mg (22.13, p < 0.001) and 1 mg (30.83 , p < 0.001) of morphine. Mean total tramadol consumption also was lower in these groups (p < 0.001) with the lowest consumption in those receiving 1 mg (p < 0.04). For the first 18 hours postoperatively, those receiving higher doses of intrathecal morphine had lower pain scores (p < 0.02) than those receiving 0.2 mg. At 24 hours and beyond, there were no significant differences in pain scores among groups. More patients in the higher dose groups developed pruritus (p = 0.01). There were no other significant differences in overall adverse effects between groups. One older patient in the 1 mg dose group developed respiratory depression.

Conclusions

Doses of 0.5 mg and 1 mg intrathecal morphine preoperatively resulted in longer postoperative pain control and less analgesic consumption with nonsignificant differences in adverse effects compared to a dose of 0.2 mg.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)

 

Nursing Implications

The provision of high-dose intrathecal morphine preoperatively resulted in improved postoperative pain control among patients receiving major abdominal surgeries for cancer. Higher doses were associated with better pain outcomes for the first 24–48 hours after surgery. The administration of high-dose intrathecal morphine necessitated careful patient selection and strict postoperative monitoring.

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Fallon, M.T., Storey, D.J., Krishan, A., Weir, C.J., Mitchell, R., Fleetwood-Walker, S.M., . . . Colvin, L.A. (2015). Cancer treatment-related neuropathic pain: Proof of concept study with menthol—A TRPM8 agonist. Supportive Care in Cancer, 23, 2769–2777. 

Study Purpose

To evaluate whether a topical menthol product has clinical benefit for pain of peripheral neuropathy

Intervention Characteristics/Basic Study Process

Patients were given a 1% menthol in aqueous cream and were instructed how to apply it to the affected area and corresponding dermatome region of the spine twice daily. Patients were followed for four to six weeks.

Sample Characteristics

  • N = 40  
  • MEAN AGE = 61 years
  • AGE RANGE = 20–89 years
  • MALES: 37%, FEMALES: 63%
  • KEY DISEASE CHARACTERISTICS: Patients had chronic neuropathic pain: 80% had chemotherapy-induced peripheral neuropathy diagnosed by a physician, and 20% had scar pain related to treatment for breast cancer. Breast and colon cancers were the most common. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Median of 11 months since chemotherapy treatment

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Open-label

Measurement Instruments/Methods

  • Brief Pain Inventory-Short Form (BPI-SF)
  • Hospital Anxiety and Depression Scale (HADS)
  • Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
  • Walking ability: GAITRite mat to measure velocity and cadence
  • Hand dexterity
  • Quantitative sensory testing (QST)

Results

Eighty-two percent showed an improvement in pain scores (p < 0.001). Significant improvements were observed in some aspects of quantitative sensory testing for mechanical detection threshold, cool stimulus, and warm stimulus. Both walking velocity and cadence improved. No significant changes in hand dexterity or LANSS scores were reported.

Conclusions

The findings suggest that the topical application of menthol can improve symptoms of chronic chemotherapy-induced peripheral neuropathy.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Subject withdrawals ≥ 10%

Nursing Implications

This study is limited by its small sample size and study design, but shows promising proof of concept results related to molecular receptors in sensory nerves that appear to respond to topical menthol. Very few interventions have been shown to prevent or effectively treat chemotherapy-induced peripheral neuropathy, so further research on the use of topical menthol is warranted. Further well designed studies are needed.

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Fallon, M., Hoskin, P.J., Colvin, L.A., Fleetwood-Walker, S.M., Adamson, D., Byrne, A., . . . Laird, B.J. (2016). Randomized double-blind trial of pregabalin versus placebo in conjunction with palliative radiotherapy for cancer-induced bone pain. Journal of Clinical Oncology, 34, 550–556. 

Study Purpose

To determine the effectiveness of pregabalin in conjunction with radiotherapy to treat patients with cancer-induced bone pain (CIBP)

Intervention Characteristics/Basic Study Process

This double-blind randomized study examined the concurrent use of pregabalin with palliative radiotherapy (versus placebo with radiotherapy) to prove the efficacy of use for treatment of CIBP. Patients were given 75 mg pregabalin or placebo twice daily for 35 days. Assessment of analgesia was done every seven days from baseline. If adequate analgesia was not achieved, trial medication was increased incrementally up to 300 mg twice daily. Radiotherapy was given in either one fraction of 8 GY or 20 Gy in five fractions.

Sample Characteristics

  • N = 233   
  • AGE:18 years or older; more than 95% of participants were 45 years or older
  • MALES: 50.9% pregabalin, 60.7% placebo; FEMALES: 49.1% pregabalin, 39.3% placebo
  • CURRENT TREATMENT: Radiation 
  • KEY DISEASE CHARACTERISTICS: Those with radiologically proven bone metastases who were scheduled to receive radiotherapy as pain treatment and who had pain scores equal to or greater than 4 on the 0–10 pain scale
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants had a life expectancy greater than two months, one or more sites of CIBP being treated with radiotherapy, the ability to provide informed consent to participate in the trial, and did not currently use gabapentin and/or pregabalin in therapeutic regimen (in other words, participation in this study would be the introduction of pregabalin in those participants, not in the placebo arm). Patients who had any change in cancer treatment therapy before entering the study (with the potential to influence pain perception) were excluded.

Setting

  • SITE: Multicenter
  • SETTING TYPE: Outpatient
  • LOCATION: Five cancer centers in the UK

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care 

Study Design

  • Multicenter, double-blinded randomized trial

Measurement Instruments/Methods

  • 0-10 Numeric Rating Scale
  • Brief Pain Inventory (BPI) for worst pain and pain interference
  • Hospital Anxiety and Depression Scale (HADS)

Results

No statistically significant differences in average pain, pain intereference, or quality of life were discovered. However, differences in mood and breakthrough pain duration, which was lesser in the pregabalin arm (p = 0.037), were present.

Conclusions

These findings do not support use of pregabalin in patients with CIBP receiving palliative radiotherapy.

Limitations

  • Optimal dose of pregabalin was not determined prior to the study.
  • No subgroup analysis based on fractionation/schedule of radiotherapy
  • No information regarding any use of bone-modifying agents

Nursing Implications

Nurses providing care to patients in the outpatient setting are in prime position to conduct further research to determine the efficacy of adjunct medications and/or other treatment modalities used for treatment of CIBP and chronic cancer pain in general. Nurses may serve as principal investigators or coinvestigators in further research to determine the most effective interventions. Nurses may also serve to make recommendations for Putting Evidence into Practice (PEP) in outpatient cancer treatment settings, and in doing so serve as patient advocates. Findings do not support the use of pregabalin for metastatic bone pain in patients with cancer.

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Fallon, M., Reale, C., Davies, A., Lux, A.E., Kumar, K., Stachowiak, A., & Galvez, R. (2011). Efficacy and safety of fentanyl pectin nasal spray compared with immediate-release morphine sulfate tablets in the treatment of breakthrough cancer pain: A multicenter, randomized, controlled, double-blind, double-dummy multiple-crossover study. Journal of Supportive Oncology, 9(6), 224–231.

Study Purpose

To compare the efficacy and tolerability of fentanyl-pectin spray (FPNS) with that of immediate-release morphine sulfate (IRMS) in the treatment of breakthrough cancer pain (BTCP)

Intervention Characteristics/Basic Study Process

Patients in the study were experiencing 1–4 episodes of BTCP per day while taking at least 60 mg/day of oral morphine or equivalent for BTCP. Patients completing the titration phase continued to the double-blind, double-dummy phase: 10 episodes of BTCP were randomly treated with FPNS and oral capsule placebo (5 episodes) or IRMS and nasal spray placebo (5 episodes). The primary end point was pain intensity (PI) difference from baseline at 15 minutes. Secondary end points were onset PI decrease (≥ 1 point) and time to clinically meaningful pain relief. Safety and tolerability were evaluated by means of adverse events (AEs) and nasal assessments. By-patient and by-episode analysis were completed. Duration of follow-up was a maximum of 14 days in the open-label period.

Sample Characteristics

  • The sample was composed of 110 patients.   
  • Mean patient age at baseline was 55.9 years (SD = 12.3 years). Of all patients, 65.1% were 60 years old or younger.
  • Of all patients, 53.8% were male and 46.2% were female.
  • All patients received fixed-schedule opioid regimens consisting of a total dose equal to or greater than 60 mg/day oral morphine for BTCP. All patients had 1-4 episodes per day of BTCP.
  • Exclusion criteria barred participation of patients
    • With uncontrolled or rapidly escalating background pain.
    • Who were medically unstable.
    • Who had breakthrough pain unrelated to cancer.
    • With a past inability to tolerate fentanyl or other opioids.
    • Who anticipated receiving therapy with any pain-affecting treatment (i.e., radiotherapy, chemotherapy) during the study or who had received treatment with another investigational drug within 30 days.
    • With any disorder or using any medication likely to adversely affect normal functioning of the nasal mucosa.

Setting

  • Multicenter (35 oncology centers)
  • Europe and India
     

Phase of Care and Clinical Applications

  • Phase of care: active treatment
  • Clinical application: palliative care

Study Design

Randomized, controlled, double-blind, double-dummy, multiple crossover trial

Measurement Instruments/Methods

  • 11-point numeric scale (0 = no pain, 10 = worst possible pain), to measure pain intensity.
  • Nasal assessments performed by the study physician.
  • Four-point scale (0 = absent, 3 = severe) of subjective nasal assessment by the patient, who completed a 10-item questionnaire before the first use of the study drug, one hour after each dose of the study medication, and at the final study visit. Items rated included stuffy/blocked nose, runny nose, itching/sneezing, crusting/dryness, burning/discomfort, nosebleed, cough, postnasal drip, sore throat, and taste disturbance.
     

Results

  • Analysis of pain intensity difference pre- and post-treatment showed that FPNS provided a greater reduction in pain intensity than did IRMS, with mean ± SE 3.02 ± 0.21 for FPNS doses and 2.69 ± 0.18 for IRMS (p < 0.05). Statistical superiority of FPNS compared with IRMS, on patient-averaged PID scores, continued at each point 15–60 minutes (p < 0.05).
  • After treatment, from 10 minutes onward, mean PI scores were lower for FPNS-treated episodes than for IRMS-treated episodes.
  • More treatment-emergent AEs occurred after FPNS than after IRMS treatment. A higher percentage of treatment-emergent AEs occurred after 400 mcg and 800 mcg doses of FPNS. Treatment-emergent AEs were mainly mild to moderate in severity and included vomiting, somnolence, dehydration, and nausea. Of all patients, 4.7% of patients withdrew from titration due to AEs.
     

Conclusions

The pain intensity difference associated with FPNS was greater than that associated with IRMS. The difference between the two measures of pain intensity was statistically significant (p < 0.05).

Limitations

  • The study was of short duration, only 14 days. This period is not long enough to evaluate potential long-term effects on the nasal mucosa.
  • The study design did not include titration to an effective dose of IRMS.

Nursing Implications

For patients receiving around-the-clock opioid treatment for chronic cancer-related breakthrough pain, FPNS appears to be effective, safe, and well tolerated. The early reduction of pain that FPNS provided either matched or exceeded that provided by IRMS. Compared to IRMS, FPNS provided more complete pain relief. The effects of long-term use of FPNS have not been evaluated; nurses must be aware that long-term effects of FPNS on the nasal mucosa are unknown.

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Falkowski, S., Trouillas, P., Duroux, J. L., Bonnetblanc, J. M., & Clavère, P. (2011). Radiodermatitis prevention with sucralfate in breast cancer: fundamental and clinical studies. Supportive Care in Cancer, 19, 57–65.

Study Purpose

To determine if sucralfate has a role in the prevention of radiodermatitis. A 1% concentration of sucralfate in lotion was tested.

Intervention Characteristics/Basic Study Process

Several zones on the breast were laid out by the investigators, with one zone in the irradiated field left untreated, one with sucralfate, and one that was not within the field of radiation therapy (RT). All patients were instructed to apply sucralfate lotion twice a day, one to two hours prior to treatment and within two hours after RT.

Sample Characteristics

  • The sample was comprised of 21 women with breast cancer.
  • Median age was 58.3 years.
  • Patients were receiving no concomitant chemotherapy treatment.
  • The treatment dose was 45 Gy.

 

Setting

Unspecified

Study Design

The study used a quasiexperimental design—patients were used as their own controls.

Measurement Instruments/Methods

  • Spectrophotometry was used to measure the response of skin on all zones compared to the zone that was not within the field of RT. Differences between the control radiated zone and the control zone that was not within the field of RT were analyzed. Changes in brightness and skin tonality were used to indicate the degree of erythema.
  • Radiation Therapy Oncology Group (RTOG) acute skin toxicity scale
  • Patients were evaluated once a week at 10 Gy, 20 Gy, 30 Gy, 40 Gy, and 50 Gy.
  • Additional variables included prior surgery, tumor location, prior chemotherapy, skin phototype, other cutaneous diseases, and systemic diseases.

Results

  • Skin became darker and redder by spectrophotometry with irradiation for all patients, with maximum skin response at weeks 4 and 5.
  • No differences existed in redness between sucralfate-treated and untreated areas.
  • Six patients had skin reactions between weeks 4 and 5 that were graded I and II on the RTOG scale.
  • Researchers suggested that the use of spectrophotometry was more effective than the RTOG scale for evaluation of skin changes.

 

Conclusions

No radioprotective effect was demonstrated with sucralfate.

Limitations

  • The study had a small sample size.
  • The authors did not state who did the rating/skin examination, and actual RTOG scale results were not reported.
  • Other studies have used a higher concentration of sucralfate (7%).
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Fahy, A.S., Jakub, J.W., Dy, B.M., Eldin, N.S., Harmsen, S., Sviggum, H., & Boughey, J.C. (2014). Paravertebral blocks in patients undergoing mastectomy with or without immediate reconstruction provides improved pain control and decreased postoperative nausea and vomiting. Annals of Surgical Oncology, 21, 3284–3289. 

Study Purpose

To evaluate whether paravertebral block use affected opioid use, antiemetic use, and length of stay in patients receiving mastectomies

Intervention Characteristics/Basic Study Process

Patient data were collected from medical records from the time periods before and after the use of paravertebral blocks (PVBs). Patients receiving unilateral mastectomies had unilateral PVBs, and those receiving bilateral mastectomies had bilateral PVBs. Blocks were placed preoperatively. All patients had general anesthesia. Prophylactic opioids and antiemetics were given intraoperatively at the discretion of the anesthesia team. Pain scores were documented with vital sign monitoring postoperatively. The results of those who had PVBs were compared to a cohort of patients who did not have PVBs.

Sample Characteristics

  • N = 526  
  • MEAN AGE = 56.5 years (range = 20–97 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer, and slightly less than half had unilateral mastectomy; about half had immediate reconstruction
  • OTHER KEY SAMPLE CHARACTERISTICS: 75% did not have axillary lymph nodes removed

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient    
  • LOCATION: Rochester, NY

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective cohort comparison

Measurement Instruments/Methods

  • Total postoperative opioid consumption
  • Length of stay less than or greater than 36 hours
  • Length of time in the postanesthesia care unit

Results

In a multivariate analysis that was controlled for age and surgeon, there was no significant difference between groups in length of stay. The percentage of patients requiring antiemetics was higher in the no-PVB group (57 versus 39%, respectively, p < 0.00001). The amount of opioids required was higher in the no-PVB group on the day of surgery (47.6 versus 40.1 morphine equivalents, respectively, p < 0.0001). Despite differences in opioid consumption, there were no significant differences between groups in pain scores. The greatest difference in opioid consumption was seen in patients receiving immediate bilateral reconstructions.

Conclusions

The use of PVBs in patients receiving mastectomies was associated with lower antiemetic and opioid consumption on the day of surgery.

Limitations

  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results 
  • Measurement/methods not well described 
  • Other limitations/explanation: The method of pain measurement and the actual timing of measurement was not described. It appeared that the analysis was done in terms of opioid consumption for only the day of surgery. The analysis did not take into account any prophylactic antiemetics or opioids given intraoperatively. No description or standardization of all relevant postoperative medications was given.

Nursing Implications

The findings of this study suggested that among patients receiving mastectomies, PVBs may reduce the need for postoperative antiemetics and opioids. However, it was not clear that the procedure actually reduced postoperative pain. This procedure appeared to be most beneficial for women having the most extensive surgical procedures. Additional well-designed research is warranted to determine the clinical benefits of PVB and its role in improving perioperative pain control.

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Fabian, C. J., Molina, R., Slavik, M., Dahlberg, S., Giri, S., & Stephens, R. (1990). Pyridoxine therapy for palmar-plantar erythrodysesthesia associated with continuous 5-fluorouracil infusion. Investigational New Drugs, 8, 57–63.

Study Purpose

Evaluate effectiveness of pyridoxine for treating PPE in patients with metastatic colon cancer who are receiving continuous 5-FU

Intervention Characteristics/Basic Study Process

Patients were treated with 5-FU 200 mg/m2 by continuous infusion (CI) until moderate to severe toxicity developed.

Five previously untreated patients who developed PPE were given oral pyridoxine (50 or 150 mg every day) when moderate PPE changes were noted.

Study conducted between September 1984 and July 1986.

Sample Characteristics

N: 25

KEY DISEASE CHARACTERISTICS: Patients with metastatic colon cancer receiving continuous 5-FU infusion (200–300 mg/m2/day).

Setting

SITE: Multi-site

LOCATION: University of Kansas Medical Center; Fred Hutchinson Cancer Research Center

 

Study Design

  • Non-randomized, non–double-blinded, uncontrolled study

Measurement Instruments/Methods

Skin toxicity was graded as follows.

  • 0 = Normal
  • 1 = Numbness, nail changes, painless swelling, or erythema
  • 2 = Painful erythema with or without swelling
  • 3 = Moist desquamation

Results

PPE developed in 16 of the 25 patients. The five previously untreated patients who developed PPE received 50 or 150 mg of oral pyridoxine per day when moderate PPE changes were noted. Reversal of PPE without interruption of 5-FU was seen in four out of five patients, and these patients continued 5-FU for a median of six months after developing PPE.

Conclusions

Oral pyridoxine may reduce incidence and severity of PPE symptoms associated with 5-FU continuous infusion.

Limitations

  • Small sample size
  • Not randomized and not double-blinded
  • Inadequate description of measurement tool/method to grade PPE symptoms
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Fabi, A., Ciccarese, M., Metro, G., Savarese, A., Giannarelli, D., Nuzzo, C.M., … Cognetti, F. (2008). Oral ondansetron is highly active as rescue antiemetic treatment for moderately emetogenic chemotherapy: Results of a randomized phase II study. Supportive Care in Cancer, 16, 1375–1380. 

Study Purpose

To test the efficacy and safety of two different schedules of ondansetron as rescue antiemetic treatment in patients who were refractory to standard antiemetic prophylaxis for delayed emesis following moderately emetogenic chemotherapy (MEC)

Intervention Characteristics/Basic Study Process

Patients were randomly allocated to one of two treatment groups for rescue antiemetic treatment: intramuscular ondansetron 8 mg or oral ondansetron 16 mg for days two to six (antiemetic prophylaxis was provided by ondansetron 8 mg IV plus dexamethasone 8 mg IV for acute emesis and dexamethasone 8 mg for four days for delayed emesis).

Sample Characteristics

  • The sample consisted of 89 participants.
  • In the intramuscular ondansetrong group, the average patient age was 58 years with a range of 27–83 years. In the oral ondansetron group, the average age was 61 years with a range of 28–79).
  • The sample was 85.4% female and 14.6% male.
  • The majority had breast, lung, and gynecologic cancers.
  • Patients received either an anthracycline chemotherapy regimen (highly emetogenic chemotherapy [HEC], MEC), a carboplatin regimen, or an irinotecan/oxaliplatin regimen.

Setting

The study was conducted at a single site, outpatient setting.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

The study design was a prospective trial (open label, phase II, randomly assigned to treatment group).

Measurement Instruments/Methods

  • Participants recorded in diaries the dates and times of emetic episodes, severity of nausea or vomiting, use of rescue treatment, and efficacy of treatment (absence or presence of further emetic events).
  • Participants also rated their personal satisfaction with the assigned rescue medication (satisfied, partially satisfied, unsatisfied).
  • The Common Terminology Criteria for Adverse Events (NCI-CTCAE. V. 3.0) was used.

Results

Oral ondansetron 16 mg was significantly superior to intramuscular ondansetron 8 mg for nausea and vomiting control during days two to six (p < 0.01). The two arms had a similar adverse event profile. A higher degree of personal satisfaction was found with oral ondansetron.

Conclusions

Because of its high efficacy and excellent tolerability, oral ondansetron is an important option in the management of MEC-related delayed emesis refractory to standard antiemetic prophylaxis.

Limitations

  • The sample was small with fewer than 100 participants.
  • No control group was included.
  • The frequency of the use of rescue medication was not reported, which may have contributed to the study results (ease of access to phone orders may have contributed to better efficacy and more satisfaction.)
  • Interpretation of results as a pure difference between orodispersible ondansetron and intramuscular ondansetron is difficult.

Nursing Implications

The oral form of ondansetron could provide satisfactory rescue for breakthrough delayed emesis when compared to the Intramuscular form of ondansetron, with a similar adverse event profile.

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