Dataset Information

Preventive effect of sensorimotor exercise and resistance training on chemotherapy-induced peripheral neuropathy: a randomised-controlled trial.

ABSTRACT:

Background

Chemotherapy-induced peripheral neuropathy (CIPN) is a common, unpleasant and usually long-lasting side effect of neurotoxic chemotherapeutic agents. This study aimed to investigate the preventive potential of sensorimotor- (SMT) and resistance training (RT) on CIPN.

Methods

Patients (N = 170) were randomised to SMT, RT or usual care (UC). Both exercise groups trained 3×/week for a total of 105 min/week during neurotoxic chemotherapy (mean length: 20 weeks). Before and 3 weeks after neurotoxic chemotherapy, CIPN signs/symptoms were assessed via Total Neuropathy Score (TNSr; primary endpoint) and EORTC QLQ-CIPN15 questionnaire. In addition, balance (centre of pressure), muscle strength (isokinetic), quality of life (QoL, EORTC QLQ-C30) and relative chemotherapy dose intensity (RDI) were investigated. The follow-up period covered 6 months after the end of chemotherapy.

Results

Intention-to-treat analyses (N = 159) revealed no differences regarding CIPN signs/symptoms. Exploratory per-protocol analyses (minimum training attendance rate 67%; N = 89) indicated that subjectively perceived sensory symptoms in the feet increased less during chemotherapy in the adherent exercisers (pooled group: SMT+RT) than in the UC group (-8.3 points (-16.1 to -0.4); P = 0.039, ES = 1.27). Furthermore, adherent exercisers received a higher RDI (96.6 ± 4.8 vs. 92.2 ± 9.4; P = 0.045), showed a better course of muscular strength (+20.8 Nm (11.2-30.4); P < 0.001, ES = 0.57) and QoL (+12.9 points (3.9-21.8); P = 0.005, ES = 0.64). During follow-up, CIPN signs/symptoms persisted in all groups.

Conclusions

This study demonstrates that SMT and/or RT alleviate subjectively perceived sensory CIPN symptoms in the feet and other clinically relevant cancer therapy-related outcomes, if an appropriate training stimulus is achieved.

Clinical trial registration

NCT02871284.

SUBMITTER: Muller J

PROVIDER: S-EPMC8476560 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:IntroductionChemotherapy-induced peripheral neuropathy (CIPN) is a prevalent and clinically meaningful side effect of cancer treatment. CIPN is induced by neurotoxic agents, causing severe sensory and/or motor deficits, resulting in disability and poor recovery, reducing patients' quality of life and limiting medical therapy. To date, effective treatment options are lacking. Whole-body vibration (WBV) training can attenuate motor and sensory deficits. We are conducting a two-armed, multicentre, assessor-blinded, randomised controlled trial, to investigate the effects of WBV on relevant symptoms of CIPN and determine the training characteristics.Methods and analysisIn this ongoing study, 44 patients who have completed therapy in the past 3 months, with a neurologically confirmed CIPN are assessed before and after a 12-week intervention and follow-up. The intervention group receives WBV twice a week. Exercises are individually tailored according to the initially determined optimal neuromuscular response. The control group receives care as usual.Primary endpoint is the patient reported reduction of CIPN-related symptoms (Functional Assessment of Cancer Therapy/Gynaecology Oncology Group-Neurotoxicity). Secondary endpoints are compound muscle action potentials, distal motor latency, conduction velocity, F-waves from the tibial and peroneal nerve, antidromic sensory nerve conduction studies of the sural nerve, normalised electromyographic activity, peripheral deep sensitivity, proprioception, balance, pain, the feasibility of training settings, quality of life and the level of physical activity.Aim, ethics and disseminationThe study was approved by both responsible ethics committees. (1) Our results may contribute to a better understanding of the effects of WBV on motor and sensory functions and (2) may provide information whether WBV at the most effective setting, is feasible for neuropathic patients. (3) Our results may also contribute to improve supportive care in oncology, thereby enhancing quality of life and enabling the optimal medical therapy. All results will be published in international peer-reviewed journals as well as a manual for clinical practice.Trial registration numberNCT03032718.

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:ObjectiveChemotherapy-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.MethodsThis 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).ResultsThe 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.ConclusionsIt was found that exercise was more effective than cold application in the management of CIPN.

Project description:Sensorimotor training (SMT) is popularly applied as exercise in rehabilitation settings, particularly for musculoskeletal pain. With insufficient evidence on its effect on pain and function, this exploratory randomised controlled trial investigated the potential effects of SMT in rehabilitation of chronic non-specific low back pain. Two arms received 9x30 minutes physiotherapy with added interventions: The experimental arm received 15 minutes of postural SMT while the comparator arm performed 15 minutes of added sub-effective low-intensity training. A treatment blinded tester assessed outcomes at baseline 2-4 days prior to intervention, pre- and post-intervention, and at 4-week follow-up. Main outcomes were pain and functional status assessed with a 0-100mm visual analogue scale and the Oswestry Disability Questionnaire. Additionally, postural control was analysed using a video-based tracking system and a pressure plate during perturbed stance. Robust, nonparametric multivariate hypothesis testing was performed. 22 patients (11 females, aged 32 to 75 years) with mild to moderate chronic pain and functional limitations were included for analysis (11 per arm). At post-intervention, average values of primary outcomes improved slightly, but not to a clinically relevant or statistically significant extent. At 4-week follow-up, there was a significant improvement by 12 percentage points (pp) on the functional status questionnaire in the SMT-group (95% confidence intervall (CI) = 5.3pp to 17.7pp, p < 0.001) but not in the control group (4 pp improvement, CI = 11.8pp to 19.2pp). However, group-by-time interaction effects for functional status (Q = 3.3, 19 p = 0.07) and pain (Q = 0.84, p = 0.51) were non-significant. Secondary kinematic outcomes did not change over time in either of the groups. Despite significant improvement of functional status after SMT, overall findings of this exploratory study suggest that SMT provides no added benefit for pain reduction or functional improvement in patients with moderate chronic non-specific low back pain.Trial registrationClinicalTrials.gov NCT02304120 and related study protocol, DOI: 10.1186/1471-2474-15-382.

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