Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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