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

ConditionChemotherapy Induced Peripheral Neuropathy (CIPN)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversiteit Antwerpen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

206 Participants

are divided into 2 treatment groups

Group A: Exercise interventionExperimental treatment 1 intervention

Group B: No formal exercise interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame

at 12 weeks follow-up

Secondary outcomes

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

Other outcomes

Compliance - adherence to exercise intervention

Evaluated with a self-composed questionnaire.

Time frame

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

Beliefs about the efficacy of treatment

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

Time frame

at 12 weeks follow-up

Safety of exercise intervention

Evaluated with a self-composed questionnaire.

Time frame

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

Patient experiences with exercise intervention

Evaluated with a self-composed questionnaire.

Time frame

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

Sponsors and contacts

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Universiteit Antwerpen

Lead sponsor

University Hospital, Antwerp

Collaborator

Universitaire Ziekenhuizen KU Leuven

Collaborator

Kom Op Tegen Kanker

Collaborator

Source ClinicalTrials.gov

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