Gehring, K., Patwardhan, S. Y., Collins, R., Groves, M. D., Etzel, C. J., Meyers, C. A., & Wefel, J. S. (2012). A randomized trial on the efficacy of methylphenidate and modafinil for improving cognitive functioning and symptoms in patients with a primary brain tumor. Journal of Neuro-Oncology, 107, 165–174.
To compare the effectiveness of immediate-release and sustained-release methylphenidate versus modafinil in improving cognitive function in patients with primary brain tumors.
Patients were randomized to receive one of the following three interventions for a total of four weeks: immediate-release methylphenidate, 10 mg twice daily; sustained-release methylphenidate, 18 mg daily; or modafinil, 200 mg daily. Neurocognitive tests were performed prior to the intervention and were repeated approximately 30 days later, after completion of the intervention.
Patients were undergoing multiple phases of care.
The study was a randomized, clinical trial.
Objective Cognitive Function Instruments
Subjective Anxiety Instruments
Subjective Depression Instruments
Subjective Fatigue Instruments
Subjective Sleep-Wake Disturbance Instrument
Although this study revealed some improvements in specific cognitive domains over time (e.g., executive function, speed of processing), it is unclear whether these improvements were due to the use of a stimulant; a specific medication (modafinil versus methylphenidate); or other variables, such as practice effects related to the absence of alternative neuropsychological tests. Making definitive interpretations based on this small study is difficult because the findings were confounded by the use of two stimulants (one with two different dosage schedules) and the lack of a control group (patients who were not receiving stimulants).
No evidence was provided to support the use of stimulants to improve cognitive function. The study supports the conduct of future research of this topic in studies with larger sample sizes and in randomized, clinical trials with a nonintervention arm.
Gehring, K., Sitskoorn, M.M., Gundy, C.M., Sikkes, S.A.M., Klein, M., Postma, T. J., . . . Aaronson, N.K. (2009). Cognitive rehabilitation in patients with gliomas: A randomized, controlled trial. Journal of Clinical Oncology, 27, 3712–3722.
The study was conducted to evaluate the effectiveness of a multifaceted cognitive rehabilitation program's (CRP's) measures of cognitive functioning in patients with gliomas whose disease was in remission.
An eligibility screening was conducted through
The randomization procedure was a minimization method balancing age, sex, education, tumor grade, hemisphere, radiotherapy, neurosurgery, disease duration, and institution.
The control group received standard care without cognitive intervention, and had contact with research staff at similar intervals as the intervention group. Control participants received a telephone-based empathy session during which attention to possible cognitive problems occurred without the provision of advice. At the study's completion, control participants were offered the opportunity to receive the intervention.
The intervention group received six weekly individual sessions of two hours each, carried out by seven neuropsychologists. Two techniques were incorporated.
Patients were recruited from 11 Dutch hospitals, including 10 neurosurgical centers.
The study utilized a randomized, controlled trial.
Eighty percent of CRP subjects reported that the intervention addressed their problems; 87% used compensation strategies regularly, and 79% indicated a decrease in the impact of cognitive problems on daily functioning. The intervention group had significantly better combined attention scores (in four out of seven tests) than the control group (p = 0.004) at the six-month follow-up. Verbal memory and attention were improved for the intervention group at the six-month follow-up, suggesting the intervention's success with some sustainment in learned skills.
Effect sizes for the CRP ranged from 0.23 to 0.55. The intervention group had significantly better combined scores on verbal memory tests than the control group (p = 0.009). Effect sizes for the intervention group on two of three tests were 0.48 and 0.43. Mental fatigue on the MFI was improved in the intervention group at the six-month follow-up (p = 0.044), with an effect size of 0.41.
Self-reported cognitive function (CFS, CFQ, burden) was better in the intervention group on completion of the CRP (p = 0.001). Effect sizes ranged from 0.31 to 0.48. However, at the six-month follow-up this improvement was maintained, while the control group continued to improve.
There were no significant differences between groups on neuropsychiatric assessment scores at baseline. There were no statistically significant group differences in attention or verbal memory scores at completion of the CRP.
CRP was useful in improving cognitive function, with sustained improvements in verbal memory and attention over time.
Gebruers, N., & Tjalma, W.A. (2016). Clinical feasibility of axillary reverse mapping and its influence on breast cancer related lymphedema: A systematic review. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 200, 117–122.
LITERATURE EVALUATED: Studies were independently evaluated by two reviewers for quality using the checklists from the Dutch Cochrane center with a 1, 0, or ? (1 = if sufficient information was available and no likelihood of bias, 0 = sufficient information but missing a criterion, ? = no information available). No meta-analysis was done.
PHASE OF CARE: Diagnostic
A total of 27 studies were systematically reviewed for content on the type of ARM, its safety, and whether it decreased the incidence of lymphedema. Three ARM procedures were described: (a) dermally injected blue dye, (b) injected radioisotope Tc-99m Nanocoll with subsequent lymphoscintigraphy, and (c) lymphofluoroscopic assessment using an intradermal injection of indocyanine green (ICG). The ARM detection rate was less in the sentinel lymph node biopsy (SLNB) cases (19.9%–100% with 100% representing one sample) than the ALND cases (46.6%–94.9%). Crossover nodes (those representing ARM and sentinel nodes) were identified in 5.6%–20% of ALND cases and 0%–14% of SLN cases. The recurrence of cancer in nodes that were ARM preserved would determine oncologic safety, in which studies from a referenced source deemed the ARM procedure as oncologically safe in clinically node negative, SLN positive cases, with the exception of the ARM and positive SLN being synonymous. The incidence of lymphedema reported for all ALND cases was 0%–30% and for all SLNB was 0%–4%. Lymphedema ranges for non-ARM ALND cases was 11.8%–53.5% and for SLN samples was 0%–15.8%.
The implications for nursing would be in the area of patient education, if and when the ARM procedure becomes a standard of care. For the present, nurses need to be knowledgeable of clinical trials involving ARM.
Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., & Maiya, G.A. (2012). Low level helium neon laser therapy for chemoradiotherapy induced oral mucositis in oral cancer patients: A randomized controlled trial. Oral Oncology, 48, 893–897.
To evaluate the therapeutic effects of a low level He-Ne laser on chemoradiation (CRT) -induced oral mucositis (OM), associated severe pain, and use of total parenteral nutrition (TPN) in patients with oral cancer
Block randomization was done using a computerized program taking primary oral cancer stage as a matching variable of 121 primary patients with oral cancer scheduled to undergo CRT (RT dosage = 66 Gray/33 fractions for five days per week and chemotherapy was three weeks cisplatin). Patients were randomized to either laser (n = 60) or placebo (n = 61). Both groups received standard oral care and hygiene. Patients and outcomes assessor were kept blinded for the laser intervention. OM, its associated pain, and TPN were assessed every week by a blinded assessor. Opioid analgesic use, weight loss, and any CRT breaks were recorded.
Laser treatments used He-Ne 632.8 nm, power output of 24 mW, beam spot diameter of 0.6 mm, noncontact method (Technomed Electronics, Advanced Laser Therapy 1000, Chennai, India). This was applied to the anatomical sites in the oral cavity (buccal mucosa, lateral and ventral tongue, labial mucosa, floor of the mouth and palate), excluding cancer site daily just before radiation session for 6.5 weeks.
The placebo group received sham therapy (the probe was kept off, and there was only a beep sound) just before radiation for 6.5 weeks.
This was a single-site study in a nonspecified setting in India.
This was a prospective double blinded, randomized controlled trial.
During the last weeks of CRT, incidence of mucositis greater than grade 2 was less in the laser group than in the placebo group (p < 0.0001). The mean duration of severe grades of OM was less than in the placebo group.
At the third week of CRT, no statistical difference was found between groups for incidence of OM, severe pain, TPN, and weight loss.
The laser group had less need for opioid use (p < 0.001). None of the patients in the laser group required a break in CRT, but 9% of patients in the placebo group required a break in CRT.
OM progressed at a slower rate in the laser group than in the placebo group. Pain was less severe as rated by pain scores, and TPN was significantly less in the laser group than in the placebo group.
Low level He-Ne laser was found to decrease the incidence of CRT-induced, severe OM and its associated pain; opioid analgesic use; and TPN for patients with oral cancer.
Low level helium neon laser therapy for the reduction of chemotherapy-induced OM in patients with oral cancer appears to be helpful, but the therapy is limited because of the need for the laser and an experienced laser therapist. The laser therapy in this study included standard oral care and hygiene; therefore, laser therapy does not eliminate this need.
Long-term follow-up on the effects of laser on OM is recommended to understand the carryover effects of laser in these patients. Studies explaining the exact mechanisms of action of laser also are recommended.
Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., Maiya, A.G., & Vadhiraja, B.M. (2012). Low level laser therapy for concurrent chemoradiotherapy induced oral mucositis in head and neck cancer patients: A triple blinded randomized controlled trial. Radiotherapy and Oncology, 104, 349–354.
To examine the efficacy of low level laser therapy (LLLT) in patients with head and neck cancer receiving chemotherapy and radiation therapy (RT)
Patients were randomly assigned to receive LLLT or sham treatment. Both groups received standard oral care and oral hygiene protocol, including frequent mouth washes with sodium bicarbonate. Patients in the LLLT group were treated with helium neon laser in 15–20 minute sessions, five sessions per week, at six anatomical sites in the oral cavity. Treatment was done daily prior to RT for 45 days. Patients, outcomes assessors, and statisticians were blinded to patient group assignment. Oral mucositis was assessed and graded daily.
This was a single-site, outpatient study conducted in India.
Patients were undergoing the active antitumor treatment phase of care.
The study design was a randomized triple-blind sham-controlled randomized clinical trial.
Prophylactic LLLT in patients with head and neck cancer receiving concomitant radiation and chemotherapy was effective in reducing the incidence of severe oral mucositis.
Without a longer-term follow up, long-term effects of LLT are not known.
Prophylactic use of LLLT was able to prevent and treat severe oral mucositis in this group of patients. This study adds to the growing body of evidence supporting the effectiveness of LLLT in patients with head and neck cancer receiving treatment, particularly in patients receiving chemotherapy with RT. Nurses can advocate for the use of LLLT in this patient population.
Gautam, A.P., Fernandes, D.J., Vidyasagar, M.S., Maiya, A.G., & Guddattu, V. (2015). Low level laser therapy against radiation induced oral mucositis in elderly head and neck cancer patients—A randomized placebo controlled trial. Journal of Photochemistry and Photobiology, B: Biology, 144C, 51–56.
To evaluate the effects of low level laser therapy (LLLT) for the prevention and treatment of radiation-induced oral mucositis (OM) in older adult patients with head and neck cancer (HNC)
LLLT seems to be an effective intervention in preventing OM in older adult patients with HNC. Larger, multisite trials are needed for validation.
Nurses are vital in educating patients on good oral hygiene both before and during radiation treatments. Nurses see patients weekly, sometimes daily, and are essential to managing OM while patients undergo treatment, in combination with other methods such as LLLT investigated in this study. Reducing OM allows more patients to finish treatment.
Gautam, A.P., Maiya, A.G., & Vidyasagar, M.S. (2011). Effect of home-based exercise program on lymphedema and quality of life in female postmastectomy patients: Pre-post intervention study. Journal of Rehabilitation Research and Development, 48(10), 1261–1268.
To determine the effectiveness of a home-based independent exercise regimen, comprised of upper-limb resistance exercises and deep breathing exercises, in relieving lymphedema symptoms and improving quality of life
Participants received education from a qualified physiotherapist on how to perform the at-home exercise regimen for the first few sessions. Once satisfactory performance of the exercises had been completed, the patients received a handout about the exercise program and a log book to journal their progress. The exercise regimen was to be performed five days a week. Deep breathing exercises were to be performed between each set. It was recommended to only increase the weight if 2 sets of 15 repetitions became very easy to perform. The exercise regimen consisted of scapular retraction, shoulder extension, scapular protraction, scapular depression, elbow flexion, elbow extension, wrist flexion and extension, and ball squeeze. Patients were monitored weekly via telephone, and the fourth week all patients had a follow-up appointment with the investigators either in the home or at the hospital.
The study took place at multiple sites in Manipal, India.
Patients were transitioning between phases of care.
The study used a pre-post design.
A statistically significant reduction in upper-limb circumference was found at three measurements (p < 0.001) and in affected upper-limb volume (p<0.001). The mean volume reduction was 122 ml. The metacarpophalanfeal joint circumference reduction measurement was not found to be statistically significant (p = 0.04). A statistically significant change in quality-of-life score from the SF-36 was found after completion of the exercise regimen.
The study has shown statistically significant improvements in limb volume and circumference reduction as well as improvement in QOL using this at-home exercise program.
Because the findings from the study is statistically significant, it would be great for this research to be repeated with a more rigorous study design (i.e., randomized controlled trial) with a larger sample size to clarify effectiveness of the exercise regimen. If repeatedly proven that this exercise regimen is effective in reducing lymphedema, it would be a good program for nurses to teach their patients during discharge instructions because it is extremely simple and anyone can complete the exercises with common household items.
Gatt, M., Willis, S., & Leuschner, S. (2016). A meta-analysis of the effectiveness and safety of kinesiology taping in the management of cancer-related lymphoedema. European Journal of Cancer Care. Advance online publication.
STUDY PURPOSE: To determine the effectiveness and safety of kinesiology taping (KT) compared to compression bandaging
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Late effects and survivorship
No statistically significant difference existed between KT and compression bandaging, although the analysis showed overall results in favor of compression bandaging with or without CDT. In five of the six studies, 10%–21% dropped out because of skin-related adverse events. Skin adverse events were reported only in KT groups. The findings regarding patient discomfort or satisfaction with the intervention were mixed. Reported limb reduction volumes varied widely. Four or five studies in the meta-analysis showed greater limb reduction volume in the compression bandaging group.
KT produced lower limb reduction volume and was associated with more skin adverse effects. No difference existed in patient comfort with KT versus compression bandages.
The findings of this analysis did not provide strong support for the use of KT because no better volume reduction existed and it was associated with more skin problems. If used in clinical practice, KT should be used with caution in patients where bandaging cannot be used. No evidence exists regarding KT use other than for upper extremity lymphedema in this review.
Gatt, M.E., Strahilevitz, J., Sharon, N., Lavie, D., Goldschmidt, N., Kalish, Y., . . . Paltiel, O.B. (2015). A randomized controlled study to determine the efficacy of garlic compounds in patients with hematological malignancies at risk for chemotherapy-related febrile neutropenia. Integrative Cancer Therapies. Advance online publication.
To evaluate the efficacy of garlic compounds to reduce the risk and severity of infections among patients with hematologic malignancies
Patients were stratified according to National Comprehensive Cancer Network criteria for febrile neutropenia (FN) to receive either garlic or a placebo. Patients began the intervention after the last day of their courses of chemotherapy and continued until the resolution of neutropenia. Garlic was given in two doses of 450 mg active compound per day.
Placebo-controlled, double blinded, randomized trial
The majority of patients in both groups developed neutropenia and febrile episodes at similar rates. The number of positive cultures was similar. More patients receiving garlic stopped before the end of the period of neutropenia (19.5% in the garlic group compared to 4% in the placebo group). In the very high-risk group, more patients receiving garlic developed fever. In the intermediate risk group, fewer patients receiving garlic developed fever. There were no adverse events associated with garlic use.
Garlic did not appear to provide any protective effect against the development of febrile episodes during neutropenia in these patients.
Garlic extract appeared to be safe for patients with hematologic malignancies but did not show any efficacy for the prevention of fever or infection during neutropenic periods.
Gaston-Johansson, F., Fall-Dickson, J. M., Nanda, J., Ohly, K. V., Stillman, S., Krumm, S., . . . Kennedy, M. J. (2000). The effectiveness of the comprehensive coping strategy program on clinical outcomes in breast cancer autologous bone marrow transplantation. Cancer Nursing, 23, 277–285.
The comprehensive coping strategy program (CCSP) provided patients with information emphasizing the use of pain control to decrease psychological distress and physical symptoms, such as fatigue. Patients were provided with handouts that explained ways to reduce pain, the use of cognitive restructuring information on distorted thinking, and positive coping self-statements. Patients were taught how to perform a brief muscle relaxation, which included a guided imagery component. Handouts were provided that described relaxation therapy and its benefits. A handheld recorder was given to patients to guide them through the relaxation exercise. Patients were instructed to use a five-minute audiotape recording at least every day and before stressful events. Patients were instructed to record their use of audiotapes and handouts in a diary. Outcomes were assessed at baseline, two days before allogeneic bone marrow transplant (ABMT), and seven days after ABMT.
National Cancer Institute (NCI)–designated comprehensive cancer center located in the eastern United States
Patients were undergoing the active treatment phase of care.
This was a randomized, controlled, prospective clinical trial that included
Visual analog scale (VAS)
Fatigue was experienced by 91% of the participants. The peak fatigue level was observed days before ABMT for both groups; the CCSP group experienced a 10.80-point increase, and the control group experienced a 20.33-point increase. The CCSP group experienced a statistically significant improvement in fatigue seven days after ABMT in comparison to the control group (p < 0.05); however, this difference disappeared after controlling for demographic variables and fatigue two days prior to ABMT. An index of nausea and fatigue was created for day seven after ABMT, and there was a statistically significant difference between the groups, with demographic variables controlled, with the control group reporting more nausea and fatigue than the intervention group (p < 0.05).
The generalizability of the results was limited to the sample, which consisted primarily of highly educated, married, Caucasian women with high incomes.