NCT06962579 The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
| NCT ID | NCT06962579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiteit Antwerpen |
| Condition | Chemotherapy Induced Peripheral Neuropathy (CIPN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 206 participants |
| Start Date | 2025-06-05 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 206 participants in total. It began in 2025-06-05 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06962579 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy Induced Peripheral Neuropathy (CIPN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06962579 currently recruiting?
Yes, NCT06962579 is actively recruiting participants. Contact the research team at lore.dams@uantwerpen.be for enrollment information.
Where is the NCT06962579 trial being conducted?
This trial is being conducted at Edegem, Belgium, Leuven, Belgium.
Who is sponsoring the NCT06962579 clinical trial?
NCT06962579 is sponsored by Universiteit Antwerpen. The trial plans to enroll 206 participants.