The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN-EX)

Universiteit Antwerpen

Status: Not yet enrolling

Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)

Treatments: Behavioral: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06962579

Edge 3857 (Other Identifier)

S69491 (Other Identifier)

6776

Details and patient eligibility

About

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.

Full description

The scientific goals of the project are:

1. The primary scientific objective of the study is to determine the effect of a patient-tailored exercise program based on exercise guidelines in oncology on sensory symptoms of CIPN (QLQ-CIPN20, sensory subscale) at short term (12 weeks) compared to usual care.
2. The secondary scientific objectives entail to examine if the exercise program has beneficial short (i.e., 12 weeks) and- or long term (i.e., 24 weeks) effects on symptoms of CIPN (QLQ-CIPN20, motor and autonomic subscale) and other biopsychosocial outcomes related to CIPN: (1) Signs of CIPN, (2) Physical functioning, (3) Psychosocial functioning, and (4) Relative dose intensity of chemotherapy.
3. The tertiary objective of this study is to perform a process evaluation. The aim of this process evaluation is to investigate the barriers and facilitators of the exercise program in patients receiving taxane- or platinum-based chemotherapy by examining adherence to the exercise program as well as how patients and healthcare providers perceive the implementation of the exercise program.

Enrollment: 206 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

Exercise intervention

Experimental group

Description:

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)

Treatment:

Behavioral: Exercise intervention

No formal exercise intervention

No Intervention group

Description:

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