Koul, R., Dufan, T., Russell, C., Guenther, W., Nugent, Z., Sun, X., & Cooke, L. (2007). Efficacy of complete decongestive therapy and manual lymphatic drainage on treatment-related lymphedema in breast cancer. International Journal of Radiation Oncology, Biology, Physics, 67(3), 841–846.
Researchers analyzed the medical records for 250 patients referred for lymphedema treatment during the first two years of the program and included 138 in the final analysis. Patients were included if their affected arms were larger than their unaffected arms at baseline and one-year follow-up measurements were available. Pre- and postvolumetric measurements were compared. The correlation with age, body mass index, and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. The therapy could include all four components of complete decongestive therapy (CDT) or only some components were omitted at the discretion of the therapists. Fifty-five percent of patients received all four components and 32% manual lymph drainage (MLD) alone. Thirteen percent with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase.
The mean age of patients in the sample was 54.3 years.
The study was conducted at an outpatient lymphedema clinic staffed by two certified Vodder therapists in Winnipeg.
Circumference was measured from the wrist to axilla.
CDT and MLD with exercises were associated with a significant reduction in lymphedema volume. The mean affected arm pretreatment volume was 2,929 ml (range 1,474–5,879). The normal arm volume range was (1,320–4,299) with a mean volume of 2,531 ml. The mean difference at baseline was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. After one year, absolute volume was reduced by 188 ml to 2,741 ml.
The study examines CDT and its components for a variety of patient needs and supports modifications of components of CDT and individualization of care.
Evidence supports a need for expert therapists.
Koukourakis, G.V., Kelekis, N., Kouvaris, J., Beli, I.K., & Kouloulias, V.E. (2010). Therapeutics interventions with anti-inflammatory creams in post radiation acute skin reactions: A systematic review of most important clinical trials. Recent Patents on Inflammation & Allergy Drug Discovery, 4(2), 149–158.
To investigate through a systematic review what topical treatments are currently advocated to manage acute skin reactions, including creams, ointments, and dressings, and what evidence there is to support the use of these treatments
Databases used were MEDLINE and Cochrane Central Register of Controlled Trials. Keywords searched radiation therapy, epidermis, acute skin reactions, and therapy. Studies were included if they
No exclusion criteria were identified in the article.
Total references retrieved, evaluation method, and comments on the literature used were not reported.
Patients were undergoing active treatment.
Washing with soap and water consistently demonstrated a benefit. The evidence for the use of aloe vera is mixed with one study showing harm. Biafine did not demonstrate a benefit nor a harm. Hyaluronic acid showed a benefit. Corticosteroid showed mixed results, with one study showing favorable results, two showing no increased benefit, and one study showing mixed results. Most of the evidence on topical sulcrafate shows no increased benefit in preventing and managing radiodermatitis. Dermofilm, a barrier film, showed a significant benefit in reducing moist desquamation among patients with breast cancer in one small study.
Additional studies with a larger sample and a blinded randomized controlled design are needed.
Kottschade, L.A., Sloan, J.A., Mazurczak, M.A., Johnson, D.B., Murphy, B.P., Rowland, K.M., . . . Loprinzi, C.L. (2011). The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: Results of a randomized phase III clinical trial. Supportive Care in Cancer, 19, 1769–1777.
The aim of the study was to evaluate the efficacy of Vitamin E for the prevention of chemotherapy-induced peripheral neuropathy.
Patients who were to receive taxane or platinum-based chemotherapy were randomized to receive placebo or vitamin E 300 mg by mouth twice daily. Treatment was begun within four days of the first chemotherapy treatment and continued throughout treatment and for one month beyond completion of chemotherapy. Patient assessments were conducted at baseline, prior to each chemotherapy treatment, and at one and six months after chemotherapy.
The study was conducted at multiple outpatient locations that were part of the North Central Cancer Treatment Group.
Phase of care
The study had a double blind, randomized, placebo-controlled trial design.
No significant differences were noted between groups regarding study outcomes.
The findings do not demonstrate an effect of Vitamin E oral supplements on peripheral neuropathy from chemotherapy.
Findings do not support the use of Vitamin E to prevent chemotherapy-induced peripheral neuropathy. Nurses can guide patients regarding the evidence in this area.
Kosugi, T., Hamada, S., Takigawa, C., Shinozaki, K., Kunikane, H., Goto, F., . . . Eguchi, K. (2014). A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: Efficacy and safety in Japanese cancer patients. Journal of Pain and Symptom Management, 47, 990–1000.
To examine the efficacy and safety of fentanyl buccal tablets (FBT) for treating breakthrough pain in patients with cancer
A dose titration of FBT was administered a maximum of four times. If ineffective, FBT was titrated to the next dose. In this double-blind study, nine tablets were prescribed, six being BTP and three a placebo. One tablet was taken per episode of breakthrough pain.
Double-blinded, placebo-controlled study
A significant difference was observed between the treatment groups and the primary endpoint. The mean was 2.4 for FBT treatment and 2 for the placebo. Regarding the effectiveness of FBT in the questioner survey, 22 and 56 subjects responded that analgesic onset of FBT occurred within 15 or within 15–30 minutes postadministraion.
In this study, FBT was well-tolerated in patients with cancer and was shown to relieve breakthrough pain in patients receiving around-the-clock opioids.
FBT may be useful in cancer-related breakthrough pain with around-the-clock dosing of opioids.
Kosaka, Y., Rai, Y., Masuda, N., Takano, T., Saeki, T., Nakamura, S., . . . Tamura, K. (2015). Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy. Supportive Care in Cancer, 23, 1137–1143.
To determine the extent to which pegfilgrastim reduces the risk of febrile neutropenia (FN) in Japanese women with early-stage breast cancer receiving docetaxel and cyclophosphamide (DC) chemotherapy
Pegfilgrastim at 3.6 mg or a placebo was administered subcutaneously on day 2 (at least 24 hours after DC chemotherapy) of a 21-day cycle. The study compared the incidence of FN between the pegfilgrastim and placebo cohorts. The incidence of FN during the first cycle of chemotherapy, incidence of hospitalization related to FN, incidence of grade 4 neutropenia, and percentage of patients who received antibiotics as a result of FN also were tracked.
Randomized, double-blinded, controlled trial using pegfilgrastim versus a placebo
FN was defined as an absolute neutrophil count < 500 and an axillary temperature at or above 37.5°C on the same day or the following day. Complete blood counts were checked on days 1, 2, 8, 11, and 15 during cycle 1 and on days 1, 2, 8, and 11 of subsequent cycles. Axillary body temperature was measured daily.
Patients treated with pegfilgrastim experienced a significantly lower incidence of FN (1.2%) compared to those who received a placebo (68.8%; p < 0.001). The measurement of secondary endpoints also revealed significant differences between the two groups. None of the patients in the pegfilgrastim group required hospitalization for FN whereas 6.9% of the placebo group did (p < 0.001). Patients who received pegfilgrastim were significantly less likely to require antibiotics to treat FN (0.6%) than those in the control group (56.6%; p < 0.001). During the first chemotherapy cycle, only one patient (0.6%) in the pegfilgrastim cohort developed FN compared to greater than half (57.8%) of the placebo group (p < 0.001). Only 4% of the pegfilgrastim group developed grade 4 neutropenia during chemotherapy whereas all of the placebo group developed this grade (p < 0.001).
Previous studies demonstrated the value of pegfilgrastim in significantly reducing FN in European and North American patients with breast cancer receiving chemotherapy with docetaxel. This study confirmed the efficacy of pegfilgrastim (using a dose of 3.6 mg) for use in Japanese female patients with breast cancer receiving DC chemotherapy. These results suggest that additional studies should be designed to determine if the lower pegfilgrastim dose of 3.6 mg is not inferior to the standard 6 mg dose.
The focus of this study was to demonstrate pegfilgrastim's efficacy in female Japanese patients with breast cancer, and it used a smaller pegfilgrastim dose than is commonly prescribed in the United States or Europe. Additional study is warranted to determine the appropriate dosage of pegfilgrastim for this particular population.
Kosaka, Y., Tanino, H., Sengoku, N., Minatani, N., Kikuchi, M., Nishimiya, H., . . . Watanabe, M. (2015). Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy. Supportive Care in Cancer, 24, 1405–1411.
To investigate if the use of a second-generation 5-HT3 receptor antagonist (palonosetron) and a NK1 receptor agonist (aprepitant) could allow a decreased dose of dexamethasone based on nausea and vomiting in patients with breast cancer receiving highly emetogenic chemotherapy
Randomization was to Group A: palonosetron IV plus dexamethasone IV with oral aprepitant on day 1 followed by 8 mg dexamethasone IV and 80 mg aprepitant PO on days 2 and 3. Group B received a placebo instead of dexamethasone on days 2 and 3. Patients were treated in the hospital.
Phase-II, single-center, single-blind, placebo-controlled, parallel, randomized trial. Randomization was done on a one to one ratio using a minimization method.
This study showed that complete control and CR revealed equivalent findings in acute and delayed chemotherapy-induced nausea and vomiting (CINV) with 1 day or 3 days of dexamethasone. No statistical differences were noted between both groups. Subgroup analysis looked at patients younger than 50 years. This also did not show any differences.
Using one dose of dexamethasone is feasible in treating CINV.
Reducing the use of dexamethasone may be possible in treating CINV prospectively. This may be critical in uncontrolled diabetics.
Korstjens, I., Mesters, I., van der Peet, E., Gijsen, B., & van den Borne, B. (2006). Quality of life of cancer survivors after physical and psychosocial rehabilitation. European Journal of Cancer Prevention, 15, 541–547.
This was a twelve-week outpatient rehabilitation program combining physical exercise and psycho-education and delivered in a group setting (12–16 participants per group). Physical training was led by two physiotherapists for two hours twice a week. Sessions aims included improving movement skills, improving strength and endurance, coping with fatigue, enhancing feelings of control, and reducing stress. Each session consisted of individual strength and endurance training (one hour) or a group sports activity (one hour), paired with 30 minutes of aqua aerobics. Each session of the group sports activity had a central theme (i.e., capability and cooperation, coordination, throwing and catching, social contact, winning and losing, relaxation). Psychoeducation sessions were led by oncology health professionals and aimed at providing support in coping with cancer and enhancing self-confidence and autonomy. Participants were provided with information on cancer-related subjects and encouraged to share their experiences as cancer survivors. Patient outcomes were assessed at baseline, week 6, and week 12.
After six weeks, participants in the intervention group experienced a significant decline in fatigue (p < 0.001) in comparison to baseline measurements. After 12 weeks, participants experienced an even greater decline in fatigue (p < 0.0001) in comparison to baseline measurements.
Future research should incorporate objective physical strength and endurance tests and validated measurement instruments for more specific psychosocial parameters.
Korstjens, I., Mesters, I., van der Peet, E., Gijsen, B., & van den Borne, B. (2006). Quality of life of cancer survivors after physical and psychosocial rehabiliation. European Journal of Cancer Prevention, 15(6), 541–547.
This 12-week physical fitness and psychoeducational rehabilitation program was conducted to enhance quality of life and recovery among cancer survivors of all types of cancer. Its physical fitness component was aimed at improving movement skills, strength, and endurance; helping participants cope with physical complaints (e.g., fatigue); and enhancing feelings of control and stress reduction. Its psychoeducational component was aimed at providing support in coping with cancer and enhancing self-confidence and autonomy.
The intervention had three components.
1. A physical fitness program involving two hours of training twice weekly with guidance from two expert physiotherapists. Each session consisted of
2. A psychoeducational program consisting of seven two-hour sessions aimed at providing support in coping with cancer and enhancing self-confidence and autonomy.
3. Information on cancer-related subjects.
Subjective measures were completed prior to the intervention, 6 weeks into the intervention, and at 12 weeks at the intervention's end.
This was a single-site study.
This was a prospective trial.
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) was used to measured global and functional quality of life using 6 subscales (global, physical, role, cognitive, emotional, social functioning) and one symptom scale on fatigue. Scores range from 0–100, with higher scores indicating higher quality of life for the global and functional scales. Higher symptom scores indicate greater fatigue.
The Tampa Kinesophobia Scale was used to measure excessive, irrational and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Two subscales were used to measure avoidance of activities (7 items) and pathologic somatic focus (4 items).
As measured by two items on the EORTC QLQ–C30, cognitive function improved at 12 weeks, but not at 6 weeks. There were significant improvements for all quality-of-life domains and fatigue for all cancer patients after 12 weeks (p < 0.05).
The authors suggest that exercise may improve cognitive functioning as well as other quality-of-life domains.
Korstjens, I., Mesters, I., May, A.M., van Weert, E., van den Hout, J.H., Ros, W., . . . van den Borne, B. (2011). Effects of cancer rehabilitation on problem-solving, anxiety and depression: A RCT comparing physical and cognitive-behavioural training versus physical training. Psychology and Health, 26(Suppl. 1), 63–82.
To examine the effects of physical therapy (PT) versus physical therapy plus cognitive behavioral therapy (CBT) interventions on problem solving, anxiety, and depression in patients with cancer
Consecutive groups of patients referred to rehabilitation centers were randomly assigned to receive either PT or PT and CBT programs for 12 weeks. PT consisted of twice weekly two-hour sessions of aerobic training, muscle-strength training, and group sports and games. CBT sessions were provided in a group format in which participants learned to apply self-management skills in striving for personal goals. Psychologists gathered self-evaluations regarding the extent to which patients adhered to the intervention protocol, and the process was evaluated via case records. Study measures were obtained at baseline, 12 weeks postrehabilitation, and three and nine months postintervention. After week 6, patients started a home-based walking program.
Prospective, single-blinded, randomized, two-group trial design
Overall baseline anxiety and depression scores of participants were significantly higher than those in the general Dutch population (p < 0.001). Immediately after the 12-week program, both groups showed small to moderate effect-size reduction in anxiety (0.45–0.55 [p < 0.001]) and depression (0.44–0.59 [p < 0.001]). At three and nine months, average effects, as measured by HADS score, continued to be lower than baseline, with effect sizes ranging from 0.24 to 0.4. Participants in both groups showed comparable changes in problem solving, anxiety, and depression. Subgroup analysis between those with initially higher and lower levels of distress showed no difference in changes in problem solving. Patients with higher distress, in both intervention groups, showed significant reduction in anxiety (p < 0.01) and depression (p < 0.01) at all study time points. At all measurement points, patients with lower distress at baseline showed levels of distress in keeping with those of the general population.
Study findings did not show that the addition of CBT to PT resulted in effects on problem solving, anxiety, or depression that were greater than the effects of PT alone. Findings did not support the hypothesis that the addition of CBT would be of greater benefit for individuals who had higher distress levels initially. Study findings show beneficial effects of PT on anxiety and depression.
Findings if this study support other findings regarding beneficial effects of physical activity in a supervised group setting. Findings of this study suggest that the addition of specific CBT interventions may not increase these effects. Analysis of results in those who had high versus low levels of distress demonstrates that those with low distress do not show a benefit.
Koopmans-Klein, G., Wagemans, M.F., Wartenberg, H.C., Van Megen, Y.J., & Huygen, F.J. (2015). The efficacy of standard laxative use for the prevention and treatment of opioid induced constipation during oxycodone use: A small Dutch observational pilot study. Expert Review of Gastroenterology and Hepatology, 10, 547–553.
To explore the effectiveness of standard laxative treatment in the prevention of oxycodone-induced constipation
From July 2013 to October 2013, standard laxative treatment consisting of polyethylene glycol (PEG) with electrolytes was started at the same time as opioid intake on day 1. Bisacodyl was prescribed, and patients took this as needed. Patients prescribed oxycodone at least 20 mg slow-release tables were started on the standard laxative treatment and followed for 28 days.
The dose of PEG and electrolytes varied between 0-3 sachets, and the bisacodyl dose varied from 5 mg-20 mg. Based on responder analysis criteria, 43% of patients (9 of 21) who were prescribed a standard laxative therapy regimen did not respond.
A standard laxative therapy regimen may not be effective in all patients given the type of opioid they may be prescribed and what their bowel function is at the start of opioid therapy.
Response to prophylactic PEG plus electrolytes is patients taking oxycodone SR is variable.