Bauer, C., Laszewski, P., & Magnan, M. (2015). Promoting adherence to skin care practices among patients receiving radiation therapy. Clinical Journal of Oncology Nursing, 19, 196–203.
To optimize patient adherence to Oncology Nursing Society's (ONS's) Putting Evidence Into Practice (PEP) recommendations for skin care and to evaluate associated satisfaction and skin condition
A skin care protocol was developed, including cleansing, use of a moisturizer, protection from the sun, and avoidance of skin friction. Patients were given written instruction sheets and videos, skin care kits were provided free of charge and nurses rehearsed to provide consistent verbal information. Outcomes measured included adherence, patient satisfaction, and skin condition. Teaching was reinforced in week 1 and 3. Adherence and skin condition were measured weekly. Results were compared to a cohort of patients who had been managed under a previous protocol. A random selection of patients who had received previous care was selected for comparison.
PHASE OF CARE: Active antitumor treatment
The onset of skin reactions was later among the new protocol group, but differences from previous care were not significant. By week 5, the proportion of patients with grade 3 and 4 was lower among patients in the current protocol. Adherence to skin cleansing and moisturizing was 93%–95%. Of the patients, 87% were extremely satisfied with the education they received.
The findings suggest that teaching patients to follow a consistent skin care protocol can be beneficial in the prevention of severe radiodermatitis.
Regular skin cleansing during radiation therapy is a recommended part of care. This study showed that a nursing educational and care protocol could facilitate patient compliance to skin cleansing and other aspects of skin care, and may improve patients' skin condition during radiation therapy.
Batlle, M., Morgades, M., Vives, S., Ferra, C., Oriol, A., Sancho, J.M., ... Ribera, J.M. (2014). Usefulness and safety of oral cryotherapy in the prevention of oral mucositis after conditioning regimens with high dose melphalan for autologous stem cell transplantation for lymphoma and myeloma. European Journal of Haematology, 9(6), 487–491.
To compare the effectiveness of oral cryotherapy (OC) to room temperature saline rinses in prevention of oral mucositis (OM) in patients with multiple myeloma (MM) and lymphoid neoplasias (NHL, HL) for autologous stem cell transplantation (ASCT)
An oral care protocol with sodium bicarbonate mouthwash from day 7 of ASCT until hospital discharge was implemented for all patients in the study. The intervention group received oral cryotherapy before infusion for 10 minutes, during infusion for 15 minutes, and after HDmel for 15 minutes. The control group received saline salt rinses at room temperature, but the schedule was not described in the study. Nurses assessed for oral mucositis on the day before ASCT and on days 3, 6, 9, and 12 after infusion.
Oral mucositis was significantly lower in the intervention group (44%) compared to the control group (82%) (p < 0.001). Grades III and IV oral mucositis were also lower in the intervention group (15%) compared to the control group (31%) (p = 0.031). There was no difference between groups in the onset or duration of mucositis.
OC is more effective than oral saline rinses in the prevention of OM, including grades III-IV OM in patients receiving conditioning regimens.
OM can interfere with nutrition and quality of life and can lead to secondary infections. Effective prophylaxis is needed to have good outcomes. Although this study had limitations, OC reduced severity of OM, is cost effective, and is well tolerated by patients. Therefore, it does offer an effective and inexpensive supportive measure.
Bass, P., Karki, S., Rhodes, D., Gonelli, S., Land, G., Watson, K., . . . Cheng, A. C. (2013). Impact of chlorhexidine-impregnated washcloths on reducing incidence of vancomycin-resistant enterococci colonization in hematology-oncology patients. American Journal of Infection Control, 41, 345–348.
To evaluate the impact of daily use of 2% chlorhexidine washcloths on the incidence of vancomycin-resistant enterococci (VRE) colonization.
The incidence of VRE colonization among oncology inpatients was examined before and after the introduction of daily use of chlorhexidine-impregnated washcloths. Each day, patients were given four impregnated washcloths, which were used individually for cleaning different parts of the body. Rectal swabs were taken on all new admissions and weekly during the inpatient stay. The baseline period was March to June 2010, and the experimental period was July to October 2010. Patients were in single rooms, although patients colonized with resistant organisms were roomed together. Prior bed occupancy with a patient colonized with VRE was used as a covariate in analysis.
Patients were undergoing the active antitumor treatment phase of care.
This was an observational study with a historical control.
During the baseline period, 7.8% of the previously uncolonized patients acquired VRE, compared to 3.8% during the experimental period (relatve risk [RR] = 0.48; 95% confidence interval [CI] [0.21, 1.09]). There was no significant effect of prior bed occupants with VRE on VRE acquisition. Patients who shared a room with a VRE-positive patient had significantly higher VRE rates (p < 0.001). There were no significant differences in central line-associated bloodstream infection rates, and few MRSA isolates were found.
The findings do not support the effectiveness of using chlorhexidine-imgregnated washcloths for the reduction of VRE colonization.
The findings from this study do not support the effectiveness of using chlorhexidine-impregnated washcloths to prevent VRE colonization.
Baruth, M., Wilcox, S., Der Ananian, C., & Heiney, S. (2013). Effects of home-based walking on quality of life and fatigue outcomes in early stage breast cancer survivors: A 12-week pilot study. Journal of Physical Activity and Health [Epub ahead of print].
To examine the effects of a home-based walking program on quality of life and fatigue.
Women were randomized to the usual care, wait list control, or intervention groups. Those in the intervention group received a 30 minute in-person counseling session and follow-up telephone counseling calls in weeks 1, 2, 4, 7, and 10. Counseling calls applied constructs of social cognitive therapy, discussing specific behavior change principles that could be used to increase walking, using a semi-structured script. Walking plans were designed for gradual increases in frequency, duration, and intensity. Women in the usual care group were asked to maintain their usual activity levels. Those in the intervention group were asked to keep daily activity logs and were given pedometers.
Fatigue declined in all patients. There was a greater decline among the intervention group, but the difference was not significant. Estimated activity level of walking METs was not significantly different between groups at baseline, but levels post-intervention are not reported. Overall, participants in the intervention group completed 86% (range = 62%–100%) of prescribed walking sessions.
Findings suggest relatively good adherence to home-based walking prescriptions and suggest that this activity may improve fatigue symptoms.
Findings suggest that a prescription for a home-based walking program can be a practical way to improve or maintain physical activity among women with breast cancer after initial treatment, and that this activity can improve symptoms of fatigue. There were multiple limitations to this study; however, multiple studies have shown that exercise is effective to reduce fatigue. Previous findings regarding self-managed exercise programs have been mixed. This pilot study suggests that a prescription for exercise, patient counseling and follow-up contacts may facilitate performance of home-based exercise.
Barton, D.L., Wos, E.J., Qin, R., Mattar, B.I., Green, N.B., Lanier, K.S., . . . Loprinzi, C.L. (2011). A double-blind, placebo-controlled trial of a topical treatment for chemotherapy-induced peripheral neuropathy: NCCTG trial N06CA. Supportive Care in Cancer, 19, 833–841.
The purpose of this study was to evaluate a compounded topical gel containing baclofen 10 mg, amitriptyline HCL 40 mg, and ketamine 20 mg in a pluronic lecithin organogel (BAK-PLO).
Participants were randomized to receive 1.31 g of a compounded gel containing 10 mg of baclofen, 40 mg of amitriptyline HCL, and 20 mg of ketamine versus an identical looking placebo gel. Instructions were to apply one level spoonful of gel topically to each area of pain, numbness, and/ or tingling, twice a day (in the morning and before bed), for four weeks duration. Participants were not allowed to treat more than four areas of pain, numbness, and/or tingling at a single time (i.e., a maximum of four spoonfuls of gel per application). A small subset of participants was asked to have blood drawn at the end of the four weeks to measure concentrations of drugs and their metabolites.
The study was conducted at 16 separate academic institutions in the United States.
Phase of care
Applications
The study was a double-blind, randomized, placebo-controlled trial.
Significant improvements in neuropathy symptoms in the hand and functioning of the hands were identified. Results in the feet were not as marked. Systemic absorption was minimal. Analysis of change in sensory neuropathy showed an effect size of about 0.28 (Cohen’s d, p = 0.053) in favor of the intervention. For the measurement subscale for motor neuropathy, the effect size of the change from baseline was 0.38 (p = 0.021). When analyzed as an ordinal scale outcome variable of negative change, no change or positive change for neuropathy symptoms, no significant difference was found between groups. No differences were noted between groups in the mood, pain, or quality-of-life measures.
Topical application of baclofen, 40 mg of amitriptyline HCL, and 20 mg of ketamine may be a useful approach to treatment of neuropathic pain related to CIPN, particularly if pain in the hands exists.
A limitation of this research was that the authors could not get U.S. Food and Drug Administration approval for the doses they originally wanted to use because of limited data on systemic absorption.
Nurses may consider use of this novel topical compound, but more data is needed before definite recommendations can be made.
Barton, D. L., Atherton, P. J., Bauer, B. A., Moore, D. F., Jr., Mattar, B. I., Lavasseur, B. I., . . . Loprinzi, C. L. (2011). The use of Valeriana officinalis (Valerian) in improving sleep in patients who are undergoing treatment for cancer: a phase III randomized, placebo-controlled, double-blind study (NCCTG Trial, N01C5). Journal of Supportive Oncology, 9, 24–31.
To assess the effect of a standardized preparation of valerian in improving sleep in patients undergoing therapy for cancer.
Patients receiving therapy for cancer who reported sleep difficulty of 4 or greater on a scale of 0 to 10 with a life expectancy of more than six months and an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 were included. Patients were randomized to receive 450 mg of oral valerian or placebo to be taken one hour before bed for eight weeks. Valerian capsules used contained 0.8% of valerenic acid. Valerian and placebo capsules were stored together so the placebo capsules would have a similar smell to the valerian capsules. Study measures were completed at baseline and four and eight weeks. Toxicity was assessed every two weeks using the Common Terminology Criteria for Adverse Events (CTCAE).
Patients were undergoing the active treatment phase of care.
The study was a randomized, controlled trial.
Total PSQI scores were not significantly different between the two groups over time. Although fewer patients in the valerian group reported sleep problems at week 8 than patients in the placebo group (64% versus 80%), no statistically significant changes in sleep problems were observed from baseline to week 8 in either group. Amount of sleep was significantly improved in the valerian group from baseline to week 4 (p = 0.008), but not from week 4 to week 8. Statistically significant improvement was observed in the valerian group in sleep latency, and 43% of patients reported reduced time to fall asleep compared to 32% of patients in the placebo group.
The Fatigue Inertia subscale of the POMS was significantly different from weeks 4 (p = –0.004) and 8 (p = 0.02), with better scores reported in the valerian group. The valerian group also scored significantly better from baseline to weeks 4 and 8 on the Fatigue Now subscale (p = 0.003 and p = 0.01, respectively) and the Usual Fatigue subscale (p = 0.02 and p = 0.046, respectively) of the BFI.
No significant differences were observed between groups for self-reported side effects at any of the data collection points. The placebo arm reported a significantly higher incidence of grade 1 alkaline phosphatase toxicity (p = 0.049).
The study showed that valerian provides no statistically significant improvement in sleep quality in patients undergoing treatment for cancer. Additional study on the effects of valerian on daytime fatigue may be warranted.
The study findings do not support the use of valerian in patients with cancer and insomnia. Additional study is needed to determine the effects of valerian on fatigue in this patient population.
Barton, D.L., Loprinzi, C.L., Quella, S.K., Sloan, J.A., Veeder, M.H., Egner, J.R., … Novotny, P. (1998). Prospective evaluation of vitamin E for hot flashes in breast cancer survivors. Journal of Clinical Oncology, 16, 495–500.
The purpose of the study was to examine the effect of vitamin E in breast cancer survivors.
Participants received an eight-week supply of study medication (400 IU of vitamin E succinate or placebo twice daily) labeled with the days and weeks for dosing.
One hundred twenty-five (125) women aged 33–67were randomized; 5 participants on the placebo-arm withdrew before starting study medication, which resulted in 120 patients assessable for toxicity. One hundred five (105) participants completed five weeks of study; 104 finished all nine weeks.
In this placebo-controlled, randomized, crossover trial, women were stratified by age (18 to 49 years and 50 years and older), current tamoxifen use (yes or no), duration of hot flashes (less than 9 months versus 9 months or more), average frequency of flashes (2–3 per day, 4–9 per day, or 10 or more per day), and current multivitamin use (yes or no).
Baseline hot-flash counts for each woman were obtained for the first seven days. Starting the second week and for the remaining seven weeks, study medication was taken, and the women continued to keep a daily diary of hot flash severity and frequency.
Treatment efficacy was measured using three variables: mean daily hot-flash frequency, mean daily hot-flash severity (grades 1 to 4 to representing mild, moderate, severe, and very severe), and mean daily hot flash score (frequency times average severity). All factors were measured during the last week of each treatment and compared with baseline week. The 105 participants who finished the first treatment period showed a similar reduction in hot flash frequencies for the two study arms. (25% versus 22%; p = .90). This effect represents an average decrease of roughly 1.6 hot flashes per day to a level of 4.7 hot flashes per day. The hot flash score decreased by 28% with vitamin E and 20% with placebo (p = .68). A crossover analysis, however, showed that vitamin E was associated with a minimal decrease in hot flashes (one less hot flash per day than was seen with a placebo) (p ≤ .05). At the study end, participants did not prefer vitamin E over the placebo. No toxicity was demonstrated.
Although this trial was able to show a hot flash reduction with vitamin E compared to a placebo, the clinical magnitude of this reduction was marginal
Barton, D.L., LaVasseur, B.I., Sloan, J.A., Stawis, A.N., Flynn, K.A., Dyar, M., ... & Loprinzi, C.L. (2010). Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. Journal of Clinical Oncology, 28, 3278-3283.
To evaluate three different doses of citalopram for management of hot flashes
Women were randomly assigned to receive 10, 20, or 30 mg citalopram or corresponding number of placebo pills daily for six weeks. Treatment was titrated weekly to achieve the target dose.
Placebo controlled RCT
There was some improvement in hot flash interference with several areas, and those on 20 and 30 mg of citalopram had significant improvement in sleep interference compared to placebo (p ≤ .01). There were no group differences in overall POMS scores. Adverse effects on sexual health were greater with 30 mg compared to placebo, but this difference was not statistically significant.
Findings show that citalopram in a dose as low as 10 mg daily can significantly improve hot flash symptoms and is not associated with toxicity. Further benefits were seen with higher doses.
Findings show that citalopram was beneficial to reduce hot flash severity. The duration of treatment in this study was only six weeks, so longer term efficacy is not clear. Patients on any longer term management with citalopram need to be monitored for side effects of the medication.
Barton, D.L., Liu, H., Dakhil, S.R., Linquist, B., Sloan, J.A., Nichols, C.R., . . . Loprinzi, C.L. (2013). Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomized, double-blind trial, N07C2. Journal of the National Cancer Institute, 105, 1230–1238.
To evaluate the efficacy of Wisconsin ginseng on cancer-related fatigue (CRF).
2,000 mg of Wisconsin ginseng or placebo BID (breakfast and lunch) over eight weeks. The assessment conducted at baseline and at four and eight weeks.
Statistically significant changes in scores for MFSI-SF between ginseng and placebo groups at four and eight weeks was in favor of ginseng, but only among those in active treatment. No differences in BFI scores were noted. Greater benefit reported among patients receiving active cancer treatment versus those who had completed treatment.
The ginseng group had improvements in fatigue scores over four- and eight-week periods without significant toxicities. However, data lacking on selected drug-ginseng interactions.
Supports use of (controlled, manufactured) Wisconsin ginseng to modify CRF; however, more research is needed to determine how to maximize positive effects. It appears that ginseng effects may only be seen during active treatment.
Barton, D.L., Burger, K., Novotny, P.J., Fitch, T. R., Kohli, S., Soori, G., . . . Loprinzi, C.L. (2013). The use of ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9. Supportive Care in Cancer, 21, 1185–1192.
Evaluate ginkgo biloba for the prevention of cognitive decline associated with adjuvant treatment for breast cancer
Patients were randomized to receive 60 mg of ginkgo biloba or a matching placebo twice a day starting before the second cycle of thermotherapy and continuing throughout treatment and 1 month beyond chemotherapy completion. Participants were stratified by type of chemotherapy, age, menopausal status, and lymph node involvement. Data were collected at baseline before the first or second chemotherapy cycle, during chemotherapy, at the first visit after chemotherapy (1 month), and at 6, 12, 18, and 24 months post-chemotherapy.
Participants were receiving active antitumor treatment.
Double-blind, randomized, placebo-controlled study
No significant differences were seen between groups over 24 months in any study measures. All cognitive test scores improved from baseline to the first chemotherapy follow-up and then stabilized.
The study does not support the use of ginkgo biloba for prevention of cognitive impairment resulting from chemotherapy treatment in women with breast cancer.
Findings do not support the use of ginkgo biloba to prevent cognitive changes resulting from chemotherapy in patients with breast cancer.