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Demiralp, M., Oflaz, F., & Komurcu, S. (2010). Effects of relaxation training on sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy. Journal of Clinical Nursing, 19, 1073–1083.

Study Purpose

To investigate the effect of progressive muscle relaxation (PMR) training on sleep quality and fatigue in Turkish women with breast cancer undergoing adjuvant chemotherapy.

Intervention Characteristics/Basic Study Process

Following the eligibility assessment and obtaining informed consent, patients in the PMR group were invited to a private practice room for relaxation training. Patients in the PMR group were given PMR therapy in addition to chemotherapy and routine nursing services at the outpatient unit. Patients in the control group had chemotherapy and routine nursing services without PMR therapy. PMR therapy was performed in 25- to 30-minute sessions on the first and fifteenth days of each chemotherapy cycle. Patients in the intervention group were given a CD and encouraged to do exercises every day at home.

Sample Characteristics

  • The sample was comprised of 27 women (PMR group, n = 14; control group, n = 13).  
  • Age ranged from 25 to 65 years.
  • To participate, patients had to be recently diagnosed with breast cancer, be undergoing adjuvant chemotherapy for the first time, and have no metastases or recent psychological treatments. 
  • All patients were living in the city where the research was performed and were literate in Turkish.

Setting

The study was conducted in the outpatient unit of the medical oncology department of the Gulhane Military Medical Academy in Turkey.  

Phase of Care and Clinical Applications

Patients were undergoing the active treatment (chemotherapy) phase of care.

Study Design

The study used a prospective, repeated-measures, quasiexperimental design with a control group.

Measurement Instruments/Methods

  • Sociodemographic and clinical characteristics
  • Pittsburgh Sleep Quality Index (PSQI)
  • Piper Fatigue Scale (PFS)

Results

The PMR group experienced a greater increase in improved sleep quality and a greater decrease in fatigue than the control group. Mean sleep efficiency, sleep distrubances, and total PSQI scores were significantly lower in the control group (p < 0.05). Total fatigue scores were significantly better in the experimental group compared to the control group (p = 0.014).

Conclusions

The findings suggested that PMR training may improve sleep quality and fatigue in patients with breast cancer undergoing adjuvant chemotherapy.

Limitations

  • The study had a small sample size.
  • The article included no discussion or measurement of adherence to home PMR; therefore, the intervention dose is unknown.
  • There was no discussion of therapist experience or education.
  • Information was lacking about therapist training or strategies to maintain intervention fidelity.
  • The study had no random assignment or attentional control.

Nursing Implications

PMR training given by a nurse may improve sleep quality and fatigue in patients with breast cancer. It is important to start relaxation training just before chemotherapy to decrease the frequency and severity of sleep problems and symptoms, such as fatigue during chemotherapy.

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DeMille, D., Deming, P., Lupinacci, P., & Jacobs, L. (2006). The effect of the neutropenic diet in the outpatient setting: A pilot study. Oncology Nursing Forum, 33, 337–343.

Study Purpose

The study examined adherence to neutropenic diet and whether differences existed in rates of hospital admissions for febrile episodes and positive blood cultures between patients who adhered to the neutropenic diet and those who did not.

Intervention Characteristics/Basic Study Process

Data collected at 6 and 12 weeks.

 

Sample Characteristics

  • The study started with 28 participants; 23 completed the study.
  • Participants' age range was 33–67 years.
  • Patients had a wide range of diagnoses (except acute leukemia and HIV). Patients with acute leukemia and HIV were excluded.
  • Adult patients were eligible to be included if they were to receive chemotherapy associated with a high degree of neutropenia and were not being treated with colony-stimulating factors (CSFs).

Setting

Outpatient cancer center

Measurement Instruments/Methods

  • Rates of hospital admissions for febrile episode
  • Rates of positive blood culture

Questionnaires were developed to document demographic and medical variables as well as baseline knowledge of food safety and the neutropenic diet. Adherence to restrictions of the neutropenic diet was measured via self-report based on “yes” or “no” questions and a food-use questionnaire. The 6- and 12-week evaluations measured dietary adherence as a self-reported subjective statement with “yes” or “no” responses.

Adherence was verified via eight questions targeting specific points of the food safety aspects and diet restrictions covered in the instruction. Patients’ degree of difficulty in following the diet was assessed using Likert scales with four response choices. Patients were questioned regarding hospital admissions; however, the researchers verified all admission information via chart review. The instrument designed to collect information was developed specifically for this study to assess the major aspects of the neutropenic diet for food safety and the diet instructions as given to patients. Content validity was established by review of the tool by a multidisciplinary team.

A chart review was conducted post-treatment to validate self-reported medical information and verify neutropenia (i.e., absolute neutrophil count [ANC] less than 1,000/mm3). The chart review was reviewed by a multidisciplinary team for content validity.

Fisher’s exact test was used to analyze proportions between the groups.

Results

30% of patients were noncompliant with the neutropenic diet.

No differences were found in the rate of febrile hospital admissions (per patient report and confirmed by chart review) and positive blood cultures between those patients who adhered to the neutropenic diet and those who did not.

Limitations

  • Reports of whether patients adhered to a neutropenic diet were done by patients via a survey at 6- and 12-week intervals, which may have decreased the accuracy of self-reported data.
  • No randomization of patients was done. The convenience sample compared patients who were compliant with a neutropenic diet with patients who were noncompliant.
  • It was a small outpatient study in one setting; therefore, results cannot be generalized.
  • Content validity of the tool was established at the institution. Reliability was not tested.

Nursing Implications

Of note, this study underscores the time spent for diet education, the question of appropriate content of diet education regarding food restrictions, and the difficulty adhering to diet requirements.

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Demers, M., Dagnault, A., & Desjardins, J. (2013). A randomized double-blind controlled trial: Impact of probiotics on diarrhea in patients treated with pelvic radiation. Clinical Nutrition (Edinburgh, Scotland), 33(5), 761–767. 

Study Purpose

To determine the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea in patients with pelvic cancer undergoing therapy, with a secondary objective to assess whether Bifilact® decreased or delayed the need for antidiarrheal medication, reduced intestinal pain, decreased hospitalization, lowered the interruption of radiotherapy treatments or doses of both radiotherapy and chemotherapy, and improved the overall well-being of patients during treatment

Intervention Characteristics/Basic Study Process

Patients were divided into three groups: prostatic cancers, gynecologic cancers without chemotherapy, and gynecologic or rectal cancers with chemotherapy. Then, using double-blind procedures, patients were block-randomized by blocks of two, four, or six patients according to random permutations. A second random block using a higher probiotic dosage was added after an interim analysis. New, random lists were generated for each stratum with a 3:1:1 ratio (higher dose, standard dose, placebo). Nutritional intervention was enacted with a diet teaching to control dietary lipids and providing recommendations on fiber and carbohydrate intake. Yogurt consumption was encouraged.

Sample Characteristics

  • N = 246  
  • MEAN AGE = Placebo 60.6 years; standard-dose 61.4 years; high-dose 62.0 years
  • MALES: Placebo 63; standard-dose 72; high-dose 66, FEMALES: Placebo 37; standard-dose 28; high-dose 34
  • KEY DISEASE CHARACTERISTICS: Prostate, endometrium, cervix, and rectum
  • OTHER KEY SAMPLE CHARACTERISTICS: Surgery placebo 35%; standard-dose 39%; high-dose 30%; chemotherapy placebo 56%; standard-dose 54%; high-dose 45%

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: L’Hôtel-Dieu de Québec University Health Center, Canada

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective, single-center, placebo-controlled, randomized, double-blinded trial

Measurement Instruments/Methods

  • World Health Organization (WHO) scale of abdominal pain
  • National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI, CTCAE) version 3.0 
  • Fecal incontinence NCI scale version 3.0 stool consistency
  • An adapted Bristol Stool Scale (BSS) was used to facilitate use by patients: grade 1 = normal stools (BSS 1–4); grade 2 = soft stools, in pieces (BSS 5–6), and grade 3 = liquid stools, no shape (BSS 7). 
  • Patients undergoing chemotherapy received a weekly complete blood count. If a patient's neutrophil count was ≤ 1.5 x 109/L, study agent was discontinued.
  • A log book was kept for symptom documentation, stools, and medications such as antidiarrheals. 
  • The European Organization for the Research and Treatment of Cancer's Quality of Life Questionairre C30 (EORTC, QLQ-C30) was completed at baseline, after radiation therapy was completed, and two weeks later.

Results

229 patients were analyzed. For the primary endpoint among all groups, there was no difference in the effectiveness of the probiotic Bifilact® (Lactobacillus acidophilus LAC-361) on moderate and severe treatment-induced diarrhea. At the 60-day point, there were more patients without moderate and severe diarrhea in the standard-dose group (35%) compared with the placebo group (17%) (hazard ratio of 0.69, p = 0.04). The postsurgical group with patients taking the standard dose had fewer patients without very severe diarrhea compared to the placebo group (97% and 74%, respectively) (p = 0.03). While undergoing therapy, the average number of bowel movements per day during treatment was less than three soft stools (p = 0.80), and the median level of abdominal pain was < 1 based on the NCI scale (p = 0.23).

Conclusions

Bifilact®, when administered in standard doses to patients with pelvic cancer undergoing therapy, may reduce the risk of radiation-induced grades 2–4 diarrhea towards the end of the treatment. While receiving radiation therapy, a standard dose of probiotics may reduce radiation-induced grade 4 diarrhea in patients who had prior surgery.

Limitations

  • Key sample group differences that could influence results

Nursing Implications

Nurses may want to consider offering counseling and education regarding probiotics as a potential alternative approach to reducing radiation-induced diarrhea.

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De Marinis, F., Eberhardt, W., Harper, P.G., Sureda, B.M., Nackaerts, K., Soerensen, J.B., . . . Tredaniel, J. (2009). Bisphosphonate use in patients with lung cancer and bone metastases: Recommendations of a European expert panel. Journal of Thoracic Oncology: Official Publication of the International Association for the Study of Lung Cancer, 4(10), 1280–1288.

Purpose & Patient Population

To review current evidence regarding the use of bisphosphonates for the treatment of lung cancer and to provide European recommendations for practice

Type of Resource/Evidence-Based Process

An expert panel of European clinical oncologists and lung cancer specialists reviewed available evidence regarding the use of bisphosphonates for the treatment of lung cancer and developed recommendations based on the evidence and clinical experience. The International Association for the Study of Lung Cancer published the resulting report. Authors did not provide specific search description, cite the process of review, or present evidence.

Guidelines & Recommendations

The report made the recommendations that follow.

  • Initial staging of lung cancer should include assessment for bone metastases.
  • In caring for patients with lung cancer with bone involvement, clinicians must consider bisphosphonate as a treatment. Such treatment will delay and prevent further bone metastases, help prevent skeleton-related events, and relieve pain.
  • Clinicians should add bisphosphonates to the treatment of those who develop bone metastases.
  • Comprehensive dental examination should precede treatment with bisphosphonates.
  • Treatment with bisphosphonates should continue as long as feasible, in the absence of severe adverse effects.
  • Bisphosphonate treatment, in combination with chemotherapy, is generally well tolerated and may produce synergistic effects.
  • Zoledronic acid is recommended for the treatment of patients with lung cancer and bone metastases.

Nursing Implications

The International Association for the Study of Lung Cancer recommends the use of bisphosphonates in general and zoledronic acid in particular for patients, with all types of lung cancer, who have bone metastases. Nurses should be aware of potential adverse events of this treatment, though it is generally well tolerated. Because bisphosphonate treatment is associated with osteonecrosis, patients should have a comprehensive dental examination and prophylaxis before starting bisphosphonate treatment. Nurses should also be aware of the potential renal effects of bisphosphonate, especially on patients whose renal function has deteriorated as the result of other nephrotoxic drugs, dehydration, renal impairment, or lack of adherence to the recommended infusion schedule for bisphosphonate.

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Delia, P., Sansotta, G., Donato, V., Frosina, P., Messina, G., De Renzis, C., & Famularo, G. (2007). Use of probiotics for prevention of radiation-induced diarrhea. World Journal of Gastroenterology, 13(6), 912–915.

Study Purpose

To examine the effect of probiotic use for prevention of radiation-induced diarrhea

Intervention Characteristics/Basic Study Process

The experimental group received high-potency probiotics (VSL#3 in one sachet) three times per day beginning on the first day of radiation therapy until the end of scheduled cycles. The VSL #3 sachet contained 450 billions/gm of viable lyophilized bacteria, including 4 strains of lactobacilli (Lactobacilli casei, L. plantarum, L acidophilus, and L. delbruekii subsp. Bulgaricus); 3 strains of Bifidobacteria (B. longum, B. breve, and B. infantis) and 1 strain of Streptococcus salivarius subsp. thermophilus.

The control group received an identical-appearing placebo.

Sample Characteristics

This study reported on 490 patients receiving adjuvant radiation therapy after surgery for sigmoid, rectal, or cervical cancer.

Study Design

This was a double blind, randomized, placebo-controlled trial.

Measurement Instruments/Methods

Efficacy endpoints included incidence and severity of radiation-induced diarrhea, the number of bowel movements (BMs) per day, and the time from start of study until need for loperamide.

Endpoints (clinical symptoms, use of medications, and any adverse events) were reviewed with patients weekly during scheduled radiation therapy treatments and again one month after completion.

Results

  • In all, 97.5% of patients in the placebo group and 99.1% of patients in the experimental group completed study.
  • More patients in the placebo group had radiation-induced enteritis and colitis (p < 0.001).
  • The placebo group experienced more severe toxicity (grade 3 or 4) (p < 0.001) and had a higher mean daily number of BMs (p < 0.001).

Conclusions

Use of a probiotic lactic-acid producing bacteria is a safe, easy, feasible approach to preventing radiation-induced diarrhea after surgery for abdominal and pelvic cancer.

Limitations

  • Severity was assessed using World Health Organization (WHO) standards whereas other studies use National Cancer Institute (NCI) standards.
  • This study looked only looked at prevention of radiation-induced diarrhea. 
  • The study did not address safety in patients who are neutropenic.

Nursing Implications

Probiotic lactic-acid-producing bacteria is safe for use in patients receiving radiation treatment, and it is not associated with bacteremia, sepsis, or septic shock. Lactobacilli lowers the production of proinflammatory cytokines and other effectors of inflammation and tissue injury. Probiotic bacteria upregulates the innate immune response in the gut and protects against invasive organisms. Further studies are needed on different probiotic preparations and mixtures.

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Del Fabbro, E., Dev, R., Hui, D., Palmer, L., & Bruera, E. (2013). Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial. Journal of Clinical Oncology, 31, 1271–1276.

Study Purpose

To compare melatonin with placebo for impact on appetite in patients with advanced cancer

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive 20 mg melatonin or identical placebo daily for 28 days. Study assessments were done at baseline and at four weeks. Patients were stratified according to whether or not they were currently receiving antitumor treatment.

Sample Characteristics

  • The study reported on a sample of 48 patients.
  • Mean patient age was 60 years, with a range of 32–86 years.
  • The sample was 56% female and 44% male.
  • All patients had locally recurrent or metastatic disease.

Setting

  • Multisite
  • Outpatient setting
  • Texas

Study Design

 The study was a double-blind, randomized, placebo-controlled trial.

Measurement Instruments/Methods

  • Edmonton Symptom Assessment Scale
  • Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F)
  • FACIT subscale questionnaire
  • Toxicity questionnaire
  • Bioimpedance for body composition and weight
     

Results

There were no significant differences between groups in symptoms or change in symptoms at four weeks. There were no differences in change in body weight or body composition. Thirty-three percent of patients were lost to follow-up.

Conclusions

Melatonin had no effect on appetite or other symptoms in patients with advanced cancer.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • Patient withdrawals were 10% or greater.

Nursing Implications

Findings of this study do not support the use of melatonin to improve appetite or other symptoms in patients with advanced cancer.

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Del Giglio, A.B., Cubero Dde, I., Lerner, T.G., Guariento, R.T., de Azevedo, R.G., Paiva, H., . . . Giglio, A.D. (2013). Purified dry extract of Paullinia cupana (guarana) (PC-18) for chemotherapy-related fatigue in patients with solid tumors: An early discontinuation study. Journal of Dietary Supplements, 10, 325–334. 

Study Purpose

To evaluate the effect of dry extract guarana (PC-18) on cancer-related fatigue (CRF) in patients with solid tumors and to evaluate the effect of maintenance doses on CRF in patients who initially improve

Intervention Characteristics/Basic Study Process

PC-18 37.5 mg orally twice daily for 21 days. Those with improved or stable BFI scores were randomized to 37.5 mg BID dosing of PC-18 or placebo for an additional 21 days.

Sample Characteristics

  • N = 40 in the induction phase and 33 in the randomization phase
  • MEAN AGE = 55.9 years in the induction phase, 52.17 years in the placebo group, and 58 years in the PC-18 group
  • MALES: 42.5% induction, 39.4% randomization; FEMALES: 57.5% induction, 60.6% randomization
  • KEY DISEASE CHARACTERISTICS: Breast: 25% induction, 30.3% randomization; colorectal: 22.5% induction, 21.2% randomization; lung: 10% induction, 9% randomization; head and neck: 12.5% induction, 9% randomization; other: 30% induction, 30% randomization.
  • OTHER KEY SAMPLE CHARACTERISTICS: Cisplatin-based chemotherapy: 25% induction, 24% randomization; doxorubicin-based: 17.5% induction, 15% randomization. All participants receiving FLOX/Xelox/FOLFOX received PC-18 after randomization (15% of randomized participants). All receiving Folfiri also received placebo after randomization (15% of randomized participants).

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified  
  • LOCATION: Sao Paulo, Brazil

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment

Study Design

  • Stage I, uncontrolled, open study
  • Patient showing improvement or stabilized BFI scores were then randomized to continue study drug or placebo.

Measurement Instruments/Methods

  • Brief Fatigue Inventory
  • FACIT-F
  • Chalder
  • HADS
  • PSQI

Results

Mean BFI score decreased by 2.503 points (p = .0002). No significant difference was noted between PC-18 and placebo groups after randomization in BFI (p = .8499), Chalder (p = .6321), FACIT-F (p = .7452), HADS-A (p = .7521), HADS-D (p = .9425), or PSQI (p = .807). There was one instance of grade III depression and one instance of grade III dizziness experienced in PC-18 that was not experienced in placebo. Grade II dizziness and tremors (one instance of each) also reported in PC-18 group, but not in placebo group.

Conclusions

BFI improvement was seen in the induction phase with no significant difference once patients were randomized. It is difficult to make any positive conclusions on guarana as all patients initially had the drug with no washout period before randomization. Potential side effects of guarana may be undesirable.

Limitations

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

 

Nursing Implications

The study is limited by its sample size and study design. Use of guarana for CRF is not supported by this study.

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Del Fabbro, E., Garcia, J.M., Dev, R., Hui, D., Williams, J., Engineer, D., . . . Bruera, E. (2013). Testosterone replacement for fatigue in hypogonadal ambulatory males with advanced cancer: A preliminary double-blind placebo-controlled trial. Supportive Care in Cancer, 21, 2599-2607.

Study Purpose

Primary Objective: To evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer using the Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-Fatigue)
 
Secondary Objectives: To evaluate the effect of testosterone replacement therapy on additional symptoms associated with hypogonadism, including depression as measured by the Hospital Anxiety and Depression Scale (HADS); low sexual desire as measured by the Sexual Desire Inventory (SDI-2); and cachexia-related quality of life as measured by the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) scale

Intervention Characteristics/Basic Study Process

Gluteal injections of testosterone or placebo were administered at baseline, day 15, day 29, day 43, and day 57. Outcome measures were determined on day 29.

Sample Characteristics

  • N = 29
  • MEAN AGE: 63 years for placebo group and 57 years for testosterone group
  • MALES: 100%
  • KEY DISEASE CHARACTERISTICS: Outpatient males with advanced cancer, bioavailable testosterone (BT) < 70 ng/dL, and fatigue scores > 3/10 on Edmonton Symptom Assessment Scale

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Texas VA Hospital and University Cancer Center

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

APPLICATIONS: Elder care and palliative care

Study Design

Randomized, double-blinded placebo-controlled trial

Measurement Instruments/Methods

  • Eastern Cooperative Oncology Group (ECOG) Performance Status
  • Edmonton Symptom Assessment Scale (ESAS)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
  • Functional Assessment of Anorexia/Cachexia Therapy (FAACT)
  • Hospital Anxiety and Depression questionnaire (HADS)
  • Sexual Desire Inventory (SDI-2)
  • International Prostatic Symptom Score (IPSS)
  • Body composition by bioimpedence
  • Six-minute walk
  • Get-Up-and-Go test
  • Handgrip strength
  • Bioavailable testosterone

Results

There were no statistically significant differences in FACIT-fatigue subscale or total scores; in testosterone levels between placebo and testosterone groups; and in the secondary outcome of anorexia/cachexia and sexual desire at day 29. ECOG-PS scores improved in the testosterone group, but the differences were not significant.

Conclusions

Testosterone replacements in hypogonadal male patients with advanced cancer did not significantly improve quality of life.

Limitations

  • Small sample (< 30)
  • Key sample group differences that could influence results
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Other limitations/explanation: Confounding variable of anemia; questionable use of bioimpedance as a measure of body composition; limited accrual; and limited length of intervention (4 weeks)

Nursing Implications

This study did not demonstrate any benefit of testosterone replacement in this group of patients.

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De Jong, F.A., Kehrer, D.F., Mathijssen, R.H., Creemers, G.J., de Bruijn, P., van Schaik, R.H., … De Jong, M.J. (2006). Prophylaxis of irinotecan-induced diarrhea with neomycin and potential role for UGT1A1*28 genotype screening: A double-blind, randomized, placebo-controlled study. Oncologist, 11, 944–954.

Intervention Characteristics/Basic Study Process

Patients were treated with 350 mg/m2 irinotecan during their first cycle of chemotherapy combined with 660 mg neomycin (n = 28; 45%) administered three times daily for three consecutive days starting two days before irinotecan or combined with placebo (n = 34; 55%). 

Sample Characteristics

The two groups were balanced for demographic parameters, hematologic function, bilirubin, and liver enzyme values. The administered dose of irinotecan did not differ significantly between groups (mean dose of 640 mg versus 679 mg, p = 0.9).

Study Design

This was a double-blind, randomized, placebo-controlled study.

Measurement Instruments/Methods

  • The National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2, was used for diarrhea, nausea, and vomiting up to three weeks following administration of irinotecan. 
  • Duration of diarrhea (in days) was scored.

Results

  • Overall incidence and severity of delayed-type diarrhea did not differ significantly between study groups (p = 0.33).
  • The neomycin group experienced a 45% lower incidence of grade 3 diarrhea compared to the placebo group (17.9% versus 32.4%; p = 0.19). However, no difference was found between study groups when combining grade 2 and 3 incidence (46.4% versus 50.0%; p = 0.78).
  • Treatment with neomycin did not result in significantly shorter duration of diarrhea (4.0 versus 4.9 days; p = 0.32).

Limitations

  • Patients receiving neomycin had a 4.5 times higher risk for grade 2 nausea than those receiving placebo (39.9% versus 8.8%; p < 0.01). 
  • A larger trial is warranted.
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Degnim, A.C., Hoskin, T.L., Brahmbhatt, R.D., Warren-Peled, A., Loprinzi, M., Pavey, E.S., . . . Esserman, L.J. (2014). Randomized trial of drain antisepsis after mastectomy and immediate prosthetic breast reconstruction. Annals of Surgical Oncology, 21, 3240–3248. 

Study Purpose

To evaluate the effects of antiseptic drain care on drain colonization and infection after immediate breast reconstruction

Intervention Characteristics/Basic Study Process

Patients undergoing bilateral mastectomy and immediate breast reconstruction had right and left breast area randomly assigned to usual drain care or the experimental protocol. All subjects received IV antibiotics within 30 minutes of surgical incision and oral antibiotics until drains were removed. All participants and family members were instructed in drain care. The experimental procedure involved application of a chlorhexidine disc to drain sites every three days and irrigation of the drainage bulb with dilute Dakins solution (0.0125% sodium hypochlorite) twice daily. Patients were followed at post-op day (POD) 6–10 for culture of drain fluid. Drains were removed as individually appropriate, and tubing and fluid were cultured at that time. Surgical site infections were identified within 365 days of surgery.

Sample Characteristics

  • N = 104 patients, 208 individual surgical sites  
  • MEDIAN AGE = 46 years
  • AGE RANGE = 25–87
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients had either breast cancer or bilateral mastectomy for cancer prevention. Over 50% had a mastectomy for risk reduction.

Setting

  • SITE: Single site  
  • SETTING TYPE: Multiple settings
  • LOCATION: Rochester, NY

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Single blind randomized, controlled parallel group trial

Measurement Instruments/Methods

  • Drain and tubing colonization defined as ≥ 50 colony-forming units
  • Surgical site infection (SSI) defined as purulent drainage, positive culture from the wound, inflammation with incision opening without positive culture, or physician diagnosis of infection. SSI was determined by team consensus, who were blinded to the study group.

Results

Drain bulb fluid colonization POD 6–10 was 9.9% with antisepsis and 20.8% with control management (p = 0.02). Drain tubing and bulb fluid colonization at removal was significantly higher in the control condition (p ≤ 0.03). At POD 30, SSI rate was 3.8% among controls and 0% with the antisepsis protocol, and at one year, SSI rate was also lower in the antisepsis group. SSI rates were not significantly different.

Conclusions

Drain antisepsis with chlorhexidine patch and irrigation with dilute Dakin’s solution was associated with reduced drain and drain fluid colonization, but did not produce significant differences in surgical-site infections.

Limitations

  • Questionable protocol fidelity
  • Care was done by patients in the home, and adherence to protocol was unclear. Usual care was not described.

Nursing Implications

The procedure tested here for drain antisepsis produced less drain colonization but did not demonstrate longer term significant results to reduce surgical site infection, though infection rates were lower with the antisepsis. Further research is warranted to confirm any significant difference. Though SSI rates tend to be rather small, SSI post bilateral mastectomy and breast reconstruction can be devastating. Drain antisepsis approaches may provide an opportunity to reduce risk of postoperative surgical-site infections in which drains are used.

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