Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06962579

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

17 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 common and disabling side effect of neurotoxic cancer treatments, causing sensory problems and weakness in the hands and feet. This condition can disrupt daily activities and affect cancer treatment. Researchers are evaluating whether a personalized exercise program following international physical activity guidelines can help prevent CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. The study also explores how patients and healthcare providers experience integrating physical activity during treatment. Participants are randomly assigned to either a 12-week personalized exercise program combined with usual care or to usual care alone, which includes advice on physical activity during cancer treatment. The exercise program involves a 30-minute one-on-one session with a physiotherapist explaining the importance of physical activity, followed by home-based aerobic exercise three times a week and supervised resistance and sensorimotor exercises twice a week. The study focuses on the short-term effects at 12 weeks and longer-term effects at 24 weeks. During the study, participants undergo various assessments including questionnaires on CIPN symptoms, physical and psychosocial functioning, pain, fatigue, sleep, mood, social participation, cognitive function, and quality of life. Researchers will also monitor chemotherapy dose intensity and physical activity levels. The main outcome is the severity of sensory CIPN symptoms at 12 weeks, with follow-up evaluations extending to 24 weeks. The study will also evaluate how well participants stick to the exercise program and gather feedback from patients and healthcare professionals on its implementation.

CONDITIONS

Brief 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, gynaecological, or colon cancer without distant metastasis
  • Chemotherapy naive (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 as assessed by oncologist
  • Advanced stage of disease
  • Known current neuropathy
  • Cognitive or physical limitations that prevent 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 for the entire study duration
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 weeks

Participants in the exercise intervention group receive a 12-week individually tailored exercise program including home-based aerobic exercise and supervised resistance and sensorimotor exercises. Participants in the control group receive standard care with advice on physical activity during chemotherapy.

Weekly visits for up to 12 weeks

Follow-up

Duration - Up to 24 weeks from start of intervention

Participants are assessed for symptoms of chemotherapy-induced peripheral neuropathy and other health outcomes up to 24 weeks after starting the intervention.

Visits at 4, 8, 12, and 24 weeks

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

P

Prof. An De Groef

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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