Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06962579

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

Led by Universiteit Antwerpen · Updated on 2025-07-09

206

Participants Needed

2

Research Sites

177 weeks

Total Duration

On this page

Sponsors

U

Universiteit Antwerpen

Lead Sponsor

U

University Hospital, Antwerp

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age above 18 years
  • Primary diagnosis of breast, gynecological, or colon cancer without distant metastasis
  • Chemotherapy-na�efve (no prior chemotherapy)
  • Scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without other neurotoxic chemotherapy
Not Eligible

You will not qualify if you...

  • Life expectancy less than six months according to the oncologist
  • Advanced stage of disease
  • Known current neuropathy
  • Cognitive or physical limitations preventing participation in low- to moderate-intensity home-based walking and resistance exercises
  • Unable to read and understand Dutch
  • Unable to provide informed consent
  • Unable to participate during the entire study period
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Antwerp University Hospital

Edegem, Belgium, 2650

Actively Recruiting

2

University Hospital Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

D

Dr. Lore Dams

CONTACT

P

Prof. An De Groef

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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