The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2028-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and/or feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Chemotherapy-Related Polyneuropathy Via Sensorimotor Exercise Training

NCT02871284

Exercise Chemotherapy-induced Polyneuropathy

COMPLETED NA

Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients

NCT06737926

Chemotherapy Induced Peripheral Neuropathy Breast Cancer Patients

RECRUITING NA

Exercise Effect on Chemotherapy-Induced Neuropathic Pain

NCT02991677

Cancer, Breast Cancer, Colorectal Cancer, Lung +1 more

ACTIVE_NOT_RECRUITING NA

Whole-body Vibration Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy

NCT03032718

Chemotherapy-induced Peripheral Neuropathy

UNKNOWN NA

Exercise-based Rehabilitation to Treat Persistent Chemotherapy Induced Peripheral Neuropathy (CIPN)

NCT06405542

Chemotherapy-induced Peripheral Neuropathy

RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The scientific goals of the project are:

1. The primary scientific objective of the study is to determine the effect of a patient-tailored exercise program based on exercise guidelines in oncology on sensory symptoms of CIPN (QLQ-CIPN20, sensory subscale) at short term (12 weeks) compared to usual care.
2. The secondary scientific objectives entail to examine if the exercise program has beneficial short (i.e., 12 weeks) and- or long term (i.e., 24 weeks) effects on symptoms of CIPN (QLQ-CIPN20, motor and autonomic subscale) and other biopsychosocial outcomes related to CIPN: (1) Signs of CIPN, (2) Physical functioning, (3) Psychosocial functioning, and (4) Relative dose intensity of chemotherapy.
3. The tertiary objective of this study is to perform a process evaluation. The aim of this process evaluation is to investigate the barriers and facilitators of the exercise program in patients receiving taxane- or platinum-based chemotherapy by examining adherence to the exercise program as well as how patients and healthcare providers perceive the implementation of the exercise program.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise intervention

Participants receive a 12-week individually tailored exercise program from the start of taxane- or platinum-based chemotherapy, in addition to the standard of care (advice on physical activity during cancer treatment)

Group Type EXPERIMENTAL

Exercise intervention

Intervention Type BEHAVIORAL

* 30-minute face-to-face session with physiotherapist outlining the state of the science on the importance and benefits of physical activity during and after cancer treatment and advising patients to engage in regular physical activity according to the general guidelines
* 12-week individually tailored exercise program

* Home-based aerobic exercise, 3 times per week at moderate intensity
* Supervised resistance and sensorimotor exercises, 2 times per week

No formal exercise intervention

Standard of care (advice on physical activity during cancer treatment)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise intervention

* 30-minute face-to-face session with physiotherapist outlining the state of the science on the importance and benefits of physical activity during and after cancer treatment and advising patients to engage in regular physical activity according to the general guidelines
* 12-week individually tailored exercise program

* Home-based aerobic exercise, 3 times per week at moderate intensity
* Supervised resistance and sensorimotor exercises, 2 times per week

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age above 18 years
* a primary diagnosis of breast, gynaecological or colon cancer, without distant metastasis
* been chemotherapy naïve
* been scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without other neurotoxic chemotherapy

Exclusion Criteria

* life expectancy of less than six months according to the patient's oncologist or designee
* advanced stage of disease
* having a known current neuropathy
* having cognitive or physical limitations that contraindicate participation in a low- to moderate intensity home-based walking and progressive resistance program (determined by the patient's oncologist)
* not able to read and understand Dutch
* not able to provide informed consent
* not able to participate during the entire study period
* pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No