Clinical trial NCT06962579: The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
Official title: The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN)
Keywords: chemotherapy induced peripheral neuropathy
exercise
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: Universitaire Ziekenhuizen KU Leuven
name: Kom Op Tegen Kanker
First posted: 2025-05-08
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

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

Primary outcomes:
measure: Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity
timeFrame: at 12 weeks follow-up
Secondary outcomes:
measure: Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity
timeFrame: at 4, 8, 12 and 24 weeks follow-up
measure: Relative dose intensity chemotherapy (%)
timeFrame: at 4, 8, 12 and 24 weeks follow-up
measure: Chemotherapy-induced peripheral neuropathy (CIPN) signs
timeFrame: at 12 and 24 weeks follow-up
measure: Pain severity hands and feet
timeFrame: at 12 and 24 weeks follow-up
measure: General pain location and interference
timeFrame: at 12 and 24 weeks follow-up
measure: Physical functioning
timeFrame: at 12 and 24 weeks follow-up
measure: Self-reported physical activity
timeFrame: at 12 and 24 weeks follow-up
measure: Objective physical activity
timeFrame: at 12 and 24 weeks follow-up
measure: Fatigue
timeFrame: at 12 and 24 weeks follow-up
measure: Sleep disturbance
timeFrame: at 12 and 24 weeks follow-up
measure: Depression
timeFrame: at 12 and 24 weeks follow-up
measure: Anxiety
timeFrame: at 12 and 24 weeks follow-up
measure: Social participation
timeFrame: at 12 and 24 weeks follow-up
measure: Support
timeFrame: at 12 and 24 weeks follow-up
measure: Cognitive function
timeFrame: at 12 and 24 weeks follow-up
measure: Health-related quality of life
timeFrame: at 12 and 24 weeks follow-up
Other outcomes:
measure: Compliance - adherence to exercise intervention
timeFrame: From enrollment to the end of the intervention period at 12 weeks
measure: Beliefs about the efficacy of treatment
timeFrame: at 12 weeks follow-up
measure: Safety of exercise intervention
timeFrame: From enrollment to the end of the intervention period at 12 weeks
measure: Patient experiences with exercise intervention
timeFrame: at 4, 8, 12 and 24 weeks follow-up
measure: Medication use
timeFrame: at 4, 8, 12 and 24 weeks follow-up
measure: Body Mass Index (BMI)
timeFrame: at 12 and 24 weeks follow-up
measure: Body composition - Extracellular water ratio
timeFrame: at 12 and 24 weeks follow-up
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
References: