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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
206
* 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
Antwerp University Hospital
Edegem, Belgium
RECRUITINGUniversity Hospital Leuven
Leuven, Belgium
RECRUITINGChemotherapy-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).
Time frame: at 12 weeks follow-up
Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity
To evaluate the sensory, motor and autonomic symptoms of CIPN, the Quality of Life Questionnaire-CIPN twenty-item scale will be used (QLQ-CIPN20). Each subscale score will be linearly transformed to a 0-100 scale with higher scores indicating greater symptom burden.
Time frame: at 4, 8, 12 and 24 weeks follow-up
Relative dose intensity chemotherapy (%)
Relative Dose Intensity (RDI) of chemotherapy, calculated as the ratio of delivered dose intensity to the planned dose intensity, expressed as a percentage.
Time frame: at 4, 8, 12 and 24 weeks follow-up
Chemotherapy-induced peripheral neuropathy (CIPN) signs
The Total Neuropathy Score clinical version (TNSc) is used to evaluate motor symptoms, pin sensation, vibration sensibility, tendon reflexes and strength in the hands and feet (score range 0-20, higher scores indicating greater severity of neuropathy).
Time frame: at 12 and 24 weeks follow-up
Pain severity hands and feet
Pain severity in the hands and feet will be evaluated with a Visual Analogue Scale (VAS). Four VAS scales will be completed: pain intensity at the present moment, mean pain intensity (global average pain intensity over the past week), maximum pain intensity (pain intensity at its maximum over the past week) and minimum pain intensity (pain intensity at its minimum over the past week).
Time frame: at 12 and 24 weeks follow-up
General pain location and interference
Pain location and pain interference will be evaluated with the Brief Pain Inventory (BPI), including a body diagram to identify painful body areas and a pain interference section measuring how pain impacts various aspects of daily life, including mood, sleep, work and social activities (score range 0-70, higher scores mean a worse outcome).
Time frame: at 12 and 24 weeks follow-up
Physical functioning
Evaluated with the PROMIS Short Form v2.0 Physical Function 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome).
Time frame: at 12 and 24 weeks follow-up
Self-reported physical activity
Self-reported levels of physical activity are measured using the Godin-Shephard Leisure-Time Physical Activity Questionnaire.
Time frame: at 12 and 24 weeks follow-up
Objective physical activity
Minutes spent in different intensity zones (sedentary, light, moderate, vigorous) will be collected using a Fitbit device.
Time frame: at 12 and 24 weeks follow-up
Fatigue
Evaluated with the Multidimensional Fatigue Inventory (score range 20-100, higher scores mean a worse outcome).
Time frame: at 12 and 24 weeks follow-up
Sleep disturbance
Evaluated with the PROMIS Short Form v1.0 Sleep Disturbance 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome).
Time frame: at 12 and 24 weeks follow-up
Depression
Evaluated with the PROMIS Short Form v1.0 Depression 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome).
Time frame: at 12 and 24 weeks follow-up
Anxiety
Evaluated with the PROMIS Short Form v1.0 Anxiety 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a worse outcome).
Time frame: at 12 and 24 weeks follow-up
Social participation
Evaluated with the PROMIS Short Form v2.0 Ability to participate in social roles and activities 8a questionnaire (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome).
Time frame: at 12 and 24 weeks follow-up
Support
Evaluated with the PROMIS Short Form v2.0 Emotional support 4a, PROMIS Short Form v2.0 Instrumental support 4a and PROMIS Short Form v2.0 Informational support 4a questionnaires (scores expressed as T-scores with a mean of 50 (SD = 10) in the general population, higher scores mean a better outcome).
Time frame: at 12 and 24 weeks follow-up
Cognitive function
Evaluated with the Cognitive Failure Questionnaire (score range 0-100, higher scores mean a worse outcome).
Time frame: at 12 and 24 weeks follow-up
Health-related quality of life
Evaluated with the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire, including the index score (based on the Belgian value set) and the EQ VAS (range 0-100), with higher scores indicating better health outcomes.
Time frame: at 12 and 24 weeks follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.