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NCT Number: NCT06962579

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

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.

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Key information

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN) Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital, Edegem, Belgium

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About this study

The scientific goals of the project are:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity

    Time frame: at 12 weeks follow-up

    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).

Secondary outcomes

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

    Time frame: at 4, 8, 12 and 24 weeks follow-up

    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.

  2. Relative dose intensity chemotherapy (%)

    Time frame: at 4, 8, 12 and 24 weeks follow-up

    Relative Dose Intensity (RDI) of chemotherapy, calculated as the ratio of delivered dose intensity to the planned dose intensity, expressed as a percentage.

  3. Chemotherapy-induced peripheral neuropathy (CIPN) signs

    Time frame: at 12 and 24 weeks follow-up

    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).

  4. Pain severity hands and feet

    Time frame: at 12 and 24 weeks follow-up

    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).

  5. General pain location and interference

    Time frame: at 12 and 24 weeks follow-up

    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).

  6. Physical functioning

    Time frame: at 12 and 24 weeks follow-up

    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).

  7. Self-reported physical activity

    Time frame: at 12 and 24 weeks follow-up

    Self-reported levels of physical activity are measured using the Godin-Shephard Leisure-Time Physical Activity Questionnaire.

  8. Objective physical activity

    Time frame: at 12 and 24 weeks follow-up

    Minutes spent in different intensity zones (sedentary, light, moderate, vigorous) will be collected using a Fitbit device.

  9. Fatigue

    Time frame: at 12 and 24 weeks follow-up

    Evaluated with the Multidimensional Fatigue Inventory (score range 20-100, higher scores mean a worse outcome).

  10. Sleep disturbance

    Time frame: at 12 and 24 weeks follow-up

    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).

  11. Depression

    Time frame: at 12 and 24 weeks follow-up

    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).

  12. Anxiety

    Time frame: at 12 and 24 weeks follow-up

    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).

  13. Social participation

    Time frame: at 12 and 24 weeks follow-up

    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).

  14. Support

    Time frame: at 12 and 24 weeks follow-up

    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).

  15. Cognitive function

    Time frame: at 12 and 24 weeks follow-up

    Evaluated with the Cognitive Failure Questionnaire (score range 0-100, higher scores mean a worse outcome).

  16. Health-related quality of life

    Time frame: at 12 and 24 weeks follow-up

    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.

Other outcomes

  1. Compliance - adherence to exercise intervention

    Time frame: From enrollment to the end of the intervention period at 12 weeks

    Evaluated with a self-composed questionnaire.

  2. Beliefs about the efficacy of treatment

    Time frame: at 12 weeks follow-up

    Evaluated with the Patient Global Impression of Change questionnaire (score range 1-7, higher scores mean a worse outcome).

  3. Safety of exercise intervention

    Time frame: From enrollment to the end of the intervention period at 12 weeks

    Evaluated with a self-composed questionnaire.

  4. Patient experiences with exercise intervention

    Time frame: at 4, 8, 12 and 24 weeks follow-up

    Evaluated with a self-composed questionnaire.

  5. Medication use

    Time frame: at 4, 8, 12 and 24 weeks follow-up

    Self-composed questionnaire.

  6. Body Mass Index (BMI)

    Time frame: at 12 and 24 weeks follow-up

    BMI (kg/m²) will be calculated based on height (measured using a stadiometer) and weight (measured with the InBody 770 device).

  7. Body composition - Extracellular water ratio

    Time frame: at 12 and 24 weeks follow-up

    The extracellular water to total body water ratio (ECW/TBW ratio) will be assessed using the InBody 770 bioimpedance analyzer.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Lore Dams

CONTACT

[email protected]

+32 3 265 16 59

Prof. An De Groef

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • Kom Op Tegen Kanker
  • Universitaire Ziekenhuizen KU Leuven
  • University Hospital, Antwerp

Registry information

Acronym: CIPN-EX

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 8, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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