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

Last updated: July 3, 2025
Sponsor: Universiteit Antwerpen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Exercise intervention

Clinical Study ID

NCT06962579
6776
S69491
Edge 3857
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age above 18 years

  • a primary diagnosis of breast, gynaecological or colon cancer, without distantmetastasis

  • been chemotherapy naïve

  • been scheduled for at least 12 weeks of taxane- or platinum-based chemotherapywithout other neurotoxic chemotherapy

Exclusion

Exclusion Criteria:

  • life expectancy of less than six months according to the patient's oncologist ordesignee

  • 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

Study Design

Total Participants: 206
Treatment Group(s): 1
Primary Treatment: Exercise intervention
Phase:
Study Start date:
June 05, 2025
Estimated Completion Date:
November 01, 2028

Study Description

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.

Connect with a study center

  • Antwerp University Hospital

    Edegem, 2650
    Belgium

    Active - Recruiting

  • University Hospital Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

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