Personalized exercise to prevent chemotherapy-related nerve damage
The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
NA · Universiteit Antwerpen · NCT06962579
This study will see if a tailored exercise program can prevent nerve-related symptoms in adults getting taxane- or platinum-based chemotherapy for breast, gynecological, or colon cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 206 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiteit Antwerpen (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Edegem and 1 other locations) |
| Trial ID | NCT06962579 on ClinicalTrials.gov |
What this trial studies
This interventional study compares a patient-tailored exercise program based on oncology physical activity guidelines to usual care for adults starting taxane- or platinum-based chemotherapy for breast, gynecological, or colon cancer. The intervention combines home-based walking and progressive resistance exercises individualized to the patient and delivered during the chemotherapy period. The primary outcome is sensory symptoms of chemotherapy‑induced peripheral neuropathy measured by the QLQ-CIPN20 sensory subscale at 12 weeks, with secondary outcomes including motor and autonomic symptoms, objective signs, physical and psychosocial functioning, and chemotherapy relative dose intensity up to 24 weeks. A process evaluation will examine adherence and barriers or facilitators by collecting experiences from patients and healthcare providers to inform future implementation.
Who should consider this trial
Good fit: Ideal candidates are adults with a new diagnosis of breast, gynecological, or colon cancer who are chemotherapy‑naïve and scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without distant metastases.
Not a fit: Patients with existing neuropathy, very limited life expectancy, advanced disease, pregnancy, or who cannot safely perform low- to moderate-intensity exercise or read Dutch are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could reduce or delay sensory nerve symptoms from chemotherapy, helping patients maintain daily function and complete planned chemotherapy.
How similar studies have performed: Small proof-of-concept and pilot trials have suggested that physical activity may help prevent CIPN, but larger definitive randomized studies are still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edegem and 1 other locations
- Antwerp University Hospital — Edegem, Belgium (RECRUITING)
- University Hospital Leuven — Leuven, Belgium (RECRUITING)
Study contacts
- Study coordinator: Dr. Lore Dams
- Email: lore.dams@uantwerpen.be
- Phone: +32 3 265 16 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chemotherapy Induced Peripheral Neuropathy, chemotherapy induced peripheral neuropathy, exercise