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

NCT06962579 | Recruiting DMC

• 3 other identifiers: 6776Edge 3857S69491
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Keywords

chemotherapy induced peripheral neuropathy; exercise

Outcome Measures

Primary Outcomes (1)

• Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity

  To evaluate the primary outcome sensory symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20 sensory subscale, score range from 9 to 36, higher scores indicating more sensory symptoms or problems).

  at 12 weeks follow-up

Secondary Outcomes (16)

• Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity

  at 4, 8, 12 and 24 weeks follow-up

• Relative dose intensity chemotherapy (%)

  at 4, 8, 12 and 24 weeks follow-up

• Chemotherapy-induced peripheral neuropathy (CIPN) signs

  at 12 and 24 weeks follow-up

• Pain severity hands and feet

  at 12 and 24 weeks follow-up

• General pain location and interference

  at 12 and 24 weeks follow-up

Other Outcomes (7)

• Compliance - adherence to exercise intervention

  From enrollment to the end of the intervention period at 12 weeks

• Beliefs about the efficacy of treatment

  at 12 weeks follow-up

• Safety of exercise intervention

  From enrollment to the end of the intervention period at 12 weeks

Study Arms (2)

Exercise intervention

EXPERIMENTAL

Participants receive a 12-week individually tailored exercise program from the start of taxane- or platinum-based chemotherapy, in addition to the standard of care (advice on physical activity during cancer treatment)

Behavioral: Exercise intervention

No formal exercise intervention

NO INTERVENTION

Standard of care (advice on physical activity during cancer treatment)

Interventions

Exercise intervention BEHAVIORAL

* 30-minute face-to-face session with physiotherapist outlining the state of the science on the importance and benefits of physical activity during and after cancer treatment and advising patients to engage in regular physical activity according to the general guidelines * 12-week individually tailored exercise program * Home-based aerobic exercise, 3 times per week at moderate intensity * Supervised resistance and sensorimotor exercises, 2 times per week

Exercise intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Kom Op Tegen Kanker: collaborator

Study Sites (2)

Antwerp University Hospital

Edegem, 2650, Belgium

RECRUITING

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Dr. Lore Dams

CONTACT

+32 3 265 16 59; lore.dams@uantwerpen.be

Prof. An De Groef

CONTACT

an.degroef@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: May 8, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: On request
• Access Criteria: On request

Locations

BE (2)