Kurita, G.P., Benthien, K.S., Nordly, M., Mercadante, S., Klepstad, P., Sjogren, P., & European Palliative Care Research Collaborative (EPCRC). (2015). The evidence of neuraxial administration of analgesics for cancer-related pain: A systematic review. Acta Anaesthesiologica Scandinavica, 59, 1103–1115.
STUDY PURPOSE: To review the evidence for the intraspinal administration of analgesics for refractory cancer-related pain
TOTAL REFERENCES RETRIEVED: 2,672
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A four-point quality scoring system was described.
PHASE OF CARE: End of life care
APPLICATIONS: Palliative care
Four studies compared combinations of opioids and adjuvant drugs to opioids alone. Two studies compared a neuraxial drug bolus with a continuous infusion, one study compared a single drug with a placebo, and two studies compared neuraxial drug administration with comprehensive medical management. Pain relief was reported in all studies comparing opioids alone or in combination with adjuvant drugs. Better analgesic effects were reported with continuous infusion compared to bolus infusion. Sample sizes were small, and the quality of the studies was low.
There was limited evidence regarding neuraxial analgesic administration for intractable pain in patients with cancer.
There were multiple methodologic concerns regarding study design and sample size. There were few studies for each type of study reviewed. Quality issues identified included loss to follow-up, unclear descriptions of setting, and no report of a power calculation. This review did not report sample sizes and graded items such as lack of setting description alone as equivalent to design issues.
There was limited evidence regarding the efficacy of intrathecal analgesic administration compared to other aggressive forms of pain control for patients with refractory pain, and the most effective drugs or drug combinations for this mode of delivery were not clear. Neuraxial treatment requires appropriate resources for safe administration and patient observation. Nurses have an important role to play regarding the selection of patients for safe home-based care delivery and the assessment of patient risks. Additional research comparing the efficacy of various aggressive pain management interventions is needed.
Kurdi, M.S., & Muthukalai, S.P. (2016). The efficacy of oral melatonin in improving sleep in cancer patients with insomnia: A randomized double-blind placebo-controlled study. Indian Journal of Palliative Care, 22, 295–300.
To conduct a randomized, double-blind, placebo-controlled efficacy study evaluating the effects of oral melatonin in improving sleep in patients with cancer experiencing symptoms of insomnia
The investigators randomized participants who consented into group A (melatonin) or group B (placebo) using a fishbowl technique. Melatonin (3 mg) or placebo (multivitamin tablet) was provided by a pharmacist. Tablets were similar in color (light yellow) and shape, and were wrapped in similar envelopes and given to participants. Instructions were to take tablets two hours prior to bedtime every day for 14 days. The Athens Insomnia Scale (AIS) was given by phone or in person on days 1, 7, and 14. Patients and evaluators were blinded to the drug group, and the group was revealed to research staff at the end of the study. Results were compared using a paired t test.
Prospective, randomized, double-blind, placebo-controlled study
The AIS self-assessment psychometric tool for measurement of sleep difficulty is an eight-item scale, and the first five items assess sleep induction, nighttime awakenings, final awakening, total sleep duration, and sleep quality. The remaining three items assess daytime well-being, functional capacity, and sleepiness. Items are scaled using 0–3 ratings, from 0 (no problem) to 3 (no sleep at all). The scale cut-off is 10 to predict outcomes.
Power for a sample size of 25 was verified (90% and alpha = 5%). No significant differences in demographic characteristics of age and sex existed (p > 0.05). Each group had one dropout. The sample was predominantly stage 1 (44% [group A], 40% [group B]) and stage 2 (32% [group A], 36% [group B]), and stage 3–4 was 24% in each group. The majority of subjects (54%) had head and neck cancer (e.g., tongue, larynx) followed by cervix cancer (12%), and 14% had ovarian, gastrointestinal, breast, and sarcomas. Group A had significantly improvements in sleep (p < 0.05) on the AIS at week 1 with intragroup improvements in group A in week 2 (p = 0.00001). The percent change in sleep improvement within group A was significant (p = 0.0001) but not significant in group B (p > 0.05).
The use of 3 mg of melatonin two hours prior to bedtime is an effective nonpharmacological treatment for increasing sleep induction and sleep quality in patients with cancer experiencing insomnia.
Additional large-scale randomized studies are needed to determine efficacy. Melatonin has emerging data to support the nonpharmacological treatment of sleep problems in patients with cancer.
Kundel, Y., Nasser, N.J., Purim, O., Yerushalmi, R., Fenig, E., Pfeffer, R.M., . . . Brenner, B. (2013). Phase II study of concurrent capecitabine and external beam radiotherapy for pain control of bone metastases of breast cancer origin. PloS One, 8, e68327.
To test the safety and efficacy of treatment with localized radiotherapy and capecitabine for management of painful bone metastases
Women with bone metastases from breast cancer received radiation with 30Gy in 10 fractions to cover all metastatic bone regions, given 5 days per week. Oral capecitabine at 1400mg/m2 was given 5 days per week, concurrently with radiation therapy. Patients were evaluated weekly during treatment and for every 4 weeks after treatment, for a total of 12 weeks after completion of treatment.
Phase-II, observational study
Side effects were mild. The most prevalent were nausea (33%), diarrhea (24%), weakness (21%), and mucositis (10%). The mean pain score decreased from 2.93 to 2.28 after one week (p < .002), to 1.45 after two weeks (p < .0001), and to 1.14 after four weeks (p < .01). Changes in pain scores after four weeks were not significant. Declines in analgesic use were noted during the first four weeks of treatment (p < .02) and were stabilized thereafter. The response rate was 31% at one week and 38% at 12 weeks. There were no differences between patients who did and did not receive bisphosphonates.
Combined radiation therapy with capecitabine was effective for the short-term reduction on pain from bone metastases with relatively mild side effects in the majority of subjects.
Combined radiation therapy and capecitabine may be a promising intervention for the palliation of painful bone metastases. Further research is needed to fully determine its efficacy and toxicity.
Kumar, S., Juresic, E., Barton, M., & Shafiq, J. (2010). Management of skin toxicity during radiation therapy: a review of the evidence. Journal of Medical Imaging and Radiation Oncology, 54, 264–279.
To review the evidence for skin care management and conduct a survey to assess current practices in Australia and New Zealand.
Databases searched were MEDLINE, PubMed, CINAHL, Google Scholar, and Google search. Searches were also completed by hand for the time period of 1980 to 2008.
Search keywords were radiation dermatitis, skin reaction, management, skin care, skin toxicity, moist desquamation, dry desquamation, erythema, sorbolene aqueous cream, and aloe vera.
Inclusion and exclusion criteria were not specified.
Thirty-one references were retrieved. Literature was evaluated on the basis of sample size. Meta-analysis was performed on studies reporting at least grade II skin toxicity.
Patients were undergoing the active antitumor treatment phase of care.
Findings were reviewed for washing, topical aloe vera, topical sucralfate, Biafine cream, corticosteroids, hyaluronic acid, barrier film, dressings, and wheatgrass extract for prophylaxis. For management, interventions included were topical steroid cream, sucralfate, and dressings. Meta-analysis across studies using any topical prophylaxis showed that any intervention was associated with lower odds of development of skin toxicity (p = 0.02). There were no significant results for management interventions. There was consistent evidence in favor of gentle washing with mild soap during RT. There was some evidence in support of corticosteroids, bepanthan, topical hyaluronic acid, calendula, and barrier films. Aloe vera was associated with higher toxicity. Evidence did not support the use of sucralfate, Biafine, or dressing for prevention. Evidence regarding interventions for management of skin toxicity was conflicted, and none produced significant effects.
Findings support the use of washing. There was some evidence in support of using corticosteroids, bepanthan, barrier films, calendula, and topical hyaluronic acid. Findings suggest that use of any topical therapy for prophylaxis may be more effective than no intervention.
Washing during RT should not be restricted. There is some evidence in support of using calendula, hyaluronic acid, no-sting barrier film, bepanthan, and topical steroids. Evidence does not support the use of aloe vera.
Kulkarni, A.P., Chaukar, D.A., Patil, V.P., Metgudmath, R.B., Hawaldar, R.W., & Divatia, J.V. (2016). Does tranexamic acid reduce blood loss during head and neck cancer surgery? Indian Journal of Anaesthesia, 60, 19–24.
To evaluate the effect of the administration of tranexamic acid (TA) upon blood loss and the need for transfusions in patients undergoing head and neck surgery
Patients undergoing supramajor head and neck surgeries were randomized to receive TA (10 mg/kg) or placebo (normal saline). The patients were stratified a priori based upon their anticipated surgical procedure. The attending anesthesiologist, blinded to the drug, administered 100 ml of solution of normal saline with or without TA (10 mg/kg) during 20 minutes postinduction of anesthesia, and, if the surgery was prolonged, every three hours during the surgery. Blood loss was measured during surgery and postoperatively for the first 24 hours. A transfusion trigger was established.
PHASE OF CARE: Active antitumor treatment
Randomized, placebo-controlled, double-blind, prospective study
Gravimetry, blood collection in suction bottles, and visual inspection were used to calculate intraoperative blood loss; postoperative blood loss was calculated with a measure of the blood collected in suction bottles during 24 hours.
Differences in intraoperative blood loss between the groups was not significant (p = 0.22); however, the placebo group demonstrated a significantly greater amount of blood loss postoperatively than the TA group (p = 0.009). This difference, however, did not translate to a significant difference between groups in the number of transfusions (p = 0.51).
The administration of TA in patients undergoing head and neck cancer surgery did not decrease intraoperative blood loss or overall blood loss; although it did reduce postoperative bleeding, this did not translate to a reduction in the number of transfusions.
Nurses must assess perioperative blood loss because it places patients at risk for serious complications. An ongoing need to evaluate measures exists to decrease this risk.
Kuhn, A., Porto, F.A., Miraglia, P., & Brunetto, A.L. (2009). Low-level infrared laser therapy in chemotherapy-induced oral mucositis: A randomized placebo-controlled trial in children. Journal of Pediatric Hematology/Oncology, 31, 33–37.
To evaluate the efficacy of low level laser therapy (LLLT) for the treatment of chemotherapy-induced oral mucositis (OM) in pediatric patients undergoing chemotherapy or stem cell transplant
Children and adolescents with cancer receiving chemotherapy or hematopoietic stem cell transplantation (HSCT) who developed grade II OM were included. OM was scored daily by the same investigator. In the experimental group, the treatment was applied to each OM lesion for five consecutive days. The control group received sham treatments to each OM lesion for five consecutive days also.
This was a single site, inpatient study conducted in the Pediatric Oncology Unit of the Hospital de Clinicas de Porto Alegre at Federal University of Rio Grande do Sul, Brazil.
The study was a randomized, placebo-controlled trial.
No differences were found in grades of mucositis as a function of the LLLT protocol. Mucositis was diagnosed 5.0 to 7.5 days postchemotherapy. On the seventh day after the diagnosis of mucositis, 1 out of 9 patients in the laser group and 9 out of 12 patients in the sham group had grade II or greater OM (p = 0.029). The mean OM duration in the laser group as compared to the sham group was 3.1 days less (p = 0.004).
LLLT can significantly reduce the duration of chemotherapy-induced OM in children.
Laser therapy is effective in treatment of mucositis, but it is very high tech and requires special equipment and highly trained personnel.
Kuderer, N.M. (2011). Meta-analysis of randomized controlled trials of granulocyte colony-stimulating factor prophylaxis in adult cancer patients receiving chemotherapy. Cancer Treatment and Research, 157, 127–143.
The primary purpose of this study was to determine the percentage of patients experiencing febrile neutropenia. A secondary goal was to examine infection-related mortality, all early mortality during chemotherapy, bone pain or musculoskeletal pain, and relative dose intensity.
Medline, EMBASE, Cancerlit, Cochrane, Database of Systematic Reviews,and Cochrane Central Register of Controlled Trials database were reviewed.
Key words include G-CSF, granulocyte–colony-stimulating factor, colony-stimulating factors (CSFs), recombinant G-CSF, lenograstim, filgrastim, pegfilgrastim, and pegylated filgrastim, randomized controlled trials
Inclusion criteria was primary and secondary G-CSF prophylaxis
Studies were excluded if they encompassed those with granulocyte macrophage–colony-stimulating factor (GM-CSF), RCTs in children, leukemia or multiple myeloma, bone marrow or peripheral blood stem cell transplantation, and studies of established neutropenia or febrile neutropenia.
12,128 potentially relevant papers were reviewed.
Cochran’s Q statistic and inconsistency index of Higgins,fixed-effects model, and random effects models.
The Jadad scale was used to evaluate study quality.
17 randomized, controlled trials (RCTs) were included.
The total sample size was 3,493 patients
The sample across all studies ranged from 31–928
Key characteristics included filgrastim in 10 trials (59%), lenograstim in six trials (35%), and pegfilgrastim in one trial (6%). Eleven trials (65%) involved patients with solid tumors and six (35%) were in patients with lymphoma, including four (24%) limited to older adult patients, eight studies using placebo control, and three that permitted secondary G-CSF in control patients (two prohibited its use and the remaining studies did not specify). Five RCTs prohibited the use of prophylactic antibiotics and three used antibiotic prophylaxis. The remaining did not specify.
Active treatment
Reductions in infection-related and early mortality with G-CSF were seen in patients with solid tumors but not among those with lymphoma.
This analysis and review confirms that primary prophylaxis with G-CSF significantly reduces the risk of febrile neutropenia while sustaining and enhancing chemotherapy dose delivery in patients receiving conventional chemotherapy across a broad range of baseline risk in eligible trials. The most important and previously unreported observation that emerged from this overview is the observed reduction in infection-related (RR = 0.552, p = 0.018) and all-cause (RR = 0.599, p = 0.002) early mortality in patients randomized to receive primary prophylaxis with G-CSF. There were no differences based on whether or not patients also received prophylactic antibiotics or between those receiving G-CSF as primary or secondary prophylaxis.
Kuderer, N.M., Dale, D.C., Crawford, J., & Lyman, G.H. (2007). Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: A systematic review. Journal of Clinical Oncology, 25, 3158–3167.
To evaluate primary granulocyte colony-stimulating factor (G-CSF) prophylaxis versus a placebo or untreated control group
DATABASES USED: Electronic databases through December 2006: MEDLINE, EMBASE, CANCERLIT, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effect, and Conference Proceedings (American Society of Clinical Oncology and American Society of Hematology). In addition, references from included articles and relevant published reports were hand searched, and references from leaders in the field were solicited. The literature search had no language restrictions.
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
FINAL NUMBER STUDIES INCLUDED = 17 RCTs of primary prophylactic G-CSF
TOTAL PATIENTS INCLUDED IN REVIEW = 3,493 patients
KEY SAMPLE CHARACTERISTICS:
The occurrence of FN was reported as an outcome in 15 trials with 3,182 patients.
Infection-related mortality was reported as an outcome in 12 trials including 1,454 control patients and 1,463 patients receiving G-CSF.
Early mortality was reported in 13 trials with 3,122 patients.
Relative dose intensity (RDI) was reported as an outcome in 10 trials. The average RDI among control patients in these studies ranged from 71.0%–95.0%, with a mean RDI of 86.7% (median RDI: 88.5%).
Bone or musculoskeletal pain during the course of chemotherapy was reported as an outcome in 14 trials including 3,029 patients.
Kucuktulu, E., Guner, A., Kahraman, I., Topbas, M., & Kucuktulu, U. (2013). The protective effects of glutamine on radiation-induced diarrhea. Supportive Care in Cancer, 21(4), 1071–1075.
To investigate the protective effects of glutamine on radiation-induced diarrhea
Patients were divided into two groups. One group received 15 g oral glutamine each day beginning one week prior to radiotherapy and continuing until one week after radiation therapy completion. The other group was given an oral glucose solution.
The study was conducted at a single outpatient site in Turkey.
Patients were undergoing the active treatment phase of care.
This was a two-group prospective trial.
No between-group differences were found in overall incidence of diarrhea. None of the patients in the glutamine group developed grade 3–4 diarrhea, compared to 69% of those in the placebo group (p = 0.0000). More patients in the placebo group required loperamide and parenteral supportive therapy.
Findings suggest that oral glutamine may be helpful in the prevention and management of severe radiation-induced diarrhea.
Findings suggest that oral glutamine may help in the prevention of severe radiation-induced diarrhea. However, study design issues limit the quality of this study. Use of glutamine warrants further investigation in large, well-designed randomized studies.
Kuchinski, A. M., Reading, M., & Lash, A. A. (2009). Treatment-related fatigue and exercise in patients with cancer: a systematic review. Medsurg Nursing, 18, 174–180.
To determine if patients receiving treatment for cancer experienced less treatment-related fatigue if they participated in a regular committed exercise regimen, compared to those who did not exercise regularly.
Databases searched were CINAHL, MEDLINE, Ovid, and ProQuest between January 2000 and October 2006.
Search keywords were fatigue, cancer, and exercise.
Studies were included in the review if
Two unpublished doctoral dissertations were also included.
Initially, 400 articles addressing the topics of fatigue, cancer, and exercise were found. When the inclusion criteria were applied, 10 studies were included. Levels of evidence presented were established using the Priority Symptom Management (PRISM) system developed by the Oncology Nursing Society. No meta-analysis was performed due to differing definitions and methods of measurement of fatigue across studies. All studies demonstrated strong levels of evidence of PRISM level I or II. Brief summaries of study design, exercise regimen, outcomes, limitations, level of evidence, and study recommendations were provided. Studies were identified within two major categories: home-based exercise interventions and out-of-home exercise interventions.
The majority of studies (eight of 10) used home-based exercise interventions.
Eight of the studies had findings that supported exercise during treatment to reduce fatigue. In the two studies that did not show differences in fatigue, one had a very small sample size and one showed poor patient adherence to the exercise regimen.
Exercise was generally well tolerated by participants, and there were no adverse events associated with exercise.
Components of the regimens that were found to be beneficial were
Theoretical foundations of studies were reviewed. These included
The evidence suggested that an individualized exercise program should be included in the treatment of patients receiving chemotherapy and/or radiation therapy. Studies have not shown any adverse effects, such as increased fatigue or falls, as a result of exercise. Studies retrieved were limited to four types of cancer: multiple myeloma, breast, lung, and prostate. Studies reviewed encompassed both early and late stages of disease.
Common limitations found among the studies reviewed included
Use of common definitions and methods of measurement of outcome variables is needed to further advance this area of study. Evidence supports the inclusion of scheduled exercise in the care plan of patients undergoing cancer treatment. It was noted that approximately 50% of healthy Americans have been shown to have difficulty initiating and maintaining an exercise program for more than three months. This suggests that individuals with cancer are likely to need professional support to begin and maintain an exercise program. Nurses’ awareness of the role of exercise can enable better education that benefits patients.