Dataset Information

Cold Application and Exercise on Development of Peripheral Neuropathy during Taxane Chemotherapy in Breast Cancer Patients: A Randomized Controlled Trial

ABSTRACT:

Objective:

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect of cancer treatment. There is no proven pharmacological application to prevent CIPN. This study was conducted to compare the effects of cold application and exercise on peripheral neuropathy development in patients with breast cancer who received taxane.

Methods:

This was a multicenter clinical trial. The study was conducted as a randomized controlled trial on breast cancer patients who had chemotherapy-induced peripheral neuropathy complaints between July 2017 and January 2018 in an outpatient chemotherapy unit of training-research and a university hospital. A standardized, home-based, 12-week exercise program involved progressive strengthening, stretching, and balance exercises. Cold packs were applied for the duration of all 12 taxane infusions and then continued at home. The standard care protocol (information about side effects) of the clinic was used for patients in the control group. Data were collected via Patient Identification Form and CIPN Assessment Tool. Demographic data were evaluated by number and percentage ratios, and the study groups' mean scores were compared by Kruskal–Wallis and Wilcoxon analyses. The data were collected at two time points including baseline (T1) and week 12 (T2).

Results:

The study was completed with a total of 90 patients, so that each of the study groups, exercise, cold application, and control groups, included 30 patients. The mean of pre- and posttest results in the cold applied group revealed an increase in hand numbness, weakness, and distress (P < 0.05). However, no significant difference existed between the means of the pre- and the posttests in the exercise group (P = 0.79–0.1). The mean scores of all the symptoms in the control group except the loss of balance increased significantly (P < 0.05). Exercise reduced CIPN symptoms of numbness in hands (P = 0.009) and in the feet (P = 0.005) significantly compared to the cold application and control.

Conclusions:

It was found that exercise was more effective than cold application in the management of CIPN.

SUBMITTER: Simsek N

PROVIDER: S-EPMC8030600 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:PURPOSE:Over half of all cancer patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy experience chemotherapy-induced peripheral neuropathy (CIPN), which includes numbness, tingling, pain, cold sensitivity, and motor impairment in the hands and feet. CIPN is a dose-limiting toxicity, potentially increasing mortality. There are no FDA-approved drugs to treat CIPN, and behavioral interventions such as exercise are promising yet understudied. This secondary analysis of our nationwide phase III randomized controlled trial of exercise for fatigue examines (1) effects of exercise on CIPN symptoms, (2) factors that predict CIPN symptoms, and (3) factors that moderate effects of exercise on CIPN symptoms. METHODS:Cancer patients (N = 355, 56 ± 11 years, 93% female, 79% breast cancer) receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy were randomized to chemotherapy or chemotherapy plus Exercise for Cancer Patients (EXCAP©®). EXCAP is a standardized, individualized, moderate-intensity, home-based, six-week progressive walking and resistance exercise program. Patients reported CIPN symptoms of numbness and tingling and hot/coldness in hands/feet (0-10 scales) pre- and post-intervention. We explored baseline neuropathy, sex, age, body mass index, cancer stage, and cancer type as possible factors associated with CIPN symptoms and exercise effectiveness. RESULTS:Exercise reduced CIPN symptoms of hot/coldness in hands/feet (-0.46 units, p = 0.045) and numbness and tingling (- 0.42 units, p = 0.061) compared to the control. Exercise reduced CIPN symptoms more for patients who were older (p = 0.086), male (p = 0.028), or had breast cancer (p = 0.076). CONCLUSIONS:Exercise appears to reduce CIPN symptoms in patients receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy. Clinicians should consider prescribing exercise for these patients. TRIAL REGISTRATION:Clinical Trials.gov , # NCT00924651, http://www.clinicaltrials.gov .

Project description:BackgroundChemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating long-term side effects in breast cancer survivors. We conducted a randomized controlled pilot trial to assess the feasibility, safety, and effects of an acupuncture intervention on CIPN in this population.Patients and methodsWomen with stage I-III breast cancer with grade 1 or higher CIPN after taxane-containing adjuvant chemotherapy were randomized 1:1 to an immediate acupuncture (IA) arm or to a waitlist control group (CG). Participants in the IA arm received 18 sessions of acupuncture over 8 weeks, then received no additional acupuncture. Patients in the CG arm received usual care over 8 weeks, followed by nine sessions of acupuncture over 8 weeks. Measures including Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF) were collected at baseline and at 4, 8, and 16 weeks after enrollment.ResultsForty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92). At 8 weeks, participants in the IA arm experienced significant improvements in PNQ sensory score (-1.0 ± 0.9 vs. -0.3 ± 0.6; p = .01), FACT-NTX summary score (8.7 ± 8.9 vs. 1.2 ± 5.4; p = .002), and BPI-SF pain severity score (-1.1 ± 1.7 vs. 0.3 ± 1.5; p = .03), compared with those in the CG arm. No serious side effects were observed.ConclusionWomen with CIPN after adjuvant taxane therapy for breast cancer experienced significant improvements in neuropathic symptoms from an 8-week acupuncture treatment regimen. Additional larger studies are needed to confirm these findings.Implications for practiceChemotherapy-induced peripheral neuropathy (CIPN) is a toxicity that often persists for months to years after the completion of adjuvant chemotherapy for early breast cancer. In a randomized pilot trial of 40 breast cancer survivors with CIPN, an 8-week acupuncture intervention (vs. usual care) led to a statistically and clinically significant improvement in subjective sensory symptoms including neuropathic pain and paresthesia. Given the lack of effective therapies and established safety profile of acupuncture, clinicians may consider acupuncture as a treatment option for mild to moderate CIPN in practice.

Project description:BackgroundMore than half of cancer patients develop severe chemotherapy-induced peripheral neuropathy (CIPN), resulting in low quality of life, negative effects on function, and challenges in treatment compliance. Most recent studies have shown that exercise therapy has a positive impact on reducing CIPN symptoms and can also improve quality of life, balance, and activity levels. The aim of this meta-analysis was to evaluate the effect of exercise therapy on the efficacy of CIPN.MethodsComputerized search of Embase, Web of Science, CNKI, Wan Fang Data, VIP, CBM for RCTs on exercise therapy for CIPN from database creation to November 2022, without language restriction. The Cochrane Handbook 5.3 risk of bias assessment tool was used to evaluate the quality of the included studies. Then Revman 5.3 software was used to evaluate the quality of the included studies. The heterogeneity of the research results is tested by I2, continuous variables were presented as weighted mean difference or standard mean difference, and confidence intervals were set at 95%. Stata15.0 was utilized to conduct a meta-analysis.ResultsA total of 15 RCTs with 1,124 patients were included. Meta-analysis showed that the test group was superior to the control group in terms of total symptom score (SMD: -0.62; 95% Cl: -0.99, -0.24), numbness, tingling, quality of life score (total score, physical, function), pain, balance, and neurotoxicity function assessment (FACT/GOG-NTX) questionnaire (p < 0.05).LimitationsThe duration and frequency of treatment are different every week, which may have some impact on the results.ConclusionExercise therapy can be effective in treating CIPN by improving symptom score (total symptom score, numbness, tingling), quality of life score (total score, physical function), pain, balance, and FACT/GOG-NTX questionnaires. It still needs to be refined and validated by more high-quality, multicenter, large-sample RCTs in the future.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022373131, identifier: CRD42022373131.

Project description:PurposeTo determine the feasibility of implementing a yoga intervention for cancer survivors with chronic CIPN pain, as well as the impact of the intervention on patient-reported outcomes.MethodsCancer survivors with chronic CIPN pain were recruited from the breast, gastrointestinal, and gynecological oncology centers at Dana-Farber Cancer Institute. Participants were randomized (2:1) to receive an 8-week yoga intervention or usual care. After 21/50 of participants were enrolled, the COVID-19 pandemic required the yoga intervention to be delivered virtually (i.e., Zoom). Pre- and post-intervention, participants self-reported CIPN and co-occurring symptom severity. Adherence to the intervention was defined as practicing ≥ 12 yoga sessions over the 8-week intervention period. Changes in patient-reported outcomes between groups were compared using Wilcoxon's rank-sum tests.ResultsParticipants (n = 28 yoga, n = 16 control) were mainly female (96%) and diagnosed with stage III/IV disease (66%). Overall, 19/28 (67.8%) of yoga group participants were adherent to the yoga protocol. Yoga group participants experienced significant within-group improvements in all patient-reported outcomes, including worst CIPN pain (median change = - 1.7, p < 0.0001) and sensory CIPN (median change = - 14.8, p < 0.0001), but only improvements in fatigue (p = 0.05) and depression (p = 0.04) were significant compared to the control. There were no differences (p > 0.05) in changes in patient-reported outcomes between in-person (n = 6) or virtual (n = 15) yoga group participants.ConclusionsYoga is a feasible non-pharmacological modality for cancer survivors with CIPN, but more information is needed regarding its impact on CIPN and other symptoms.Trial registrationClinicalTrials.gov Identifier: NCT03824860 IMPLICATIONS FOR CANCER SURVIVORS: Oncology clinicians may consider referring cancer survivors to yoga for chronic CIPN pain, but yoga cannot be currently recommended as an efficacious treatment.