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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Exercise intervention
  * 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

Первичные конечные точки

• Chemotherapy-induced peripheral neuropathy (CIPN) sensory symptom severity [Срок оценки: at 12 weeks follow-up]

Вторичные конечные точки (12)

• Chemotherapy-induced peripheral neuropathy (CIPN) sensory, motor and autonomic symptom severity [Срок оценки: at 4, 8, 12 and 24 weeks follow-up]
• Relative dose intensity chemotherapy (%) [Срок оценки: at 4, 8, 12 and 24 weeks follow-up]
• Chemotherapy-induced peripheral neuropathy (CIPN) signs [Срок оценки: at 12 and 24 weeks follow-up]
• Pain severity hands and feet [Срок оценки: at 12 and 24 weeks follow-up]
• General pain location and interference [Срок оценки: at 12 and 24 weeks follow-up]
• Physical functioning [Срок оценки: at 12 and 24 weeks follow-up]
• Self-reported physical activity [Срок оценки: at 12 and 24 weeks follow-up]
• Objective physical activity [Срок оценки: at 12 and 24 weeks follow-up]
• Fatigue [Срок оценки: at 12 and 24 weeks follow-up]
• Sleep disturbance [Срок оценки: at 12 and 24 weeks follow-up]
• Depression [Срок оценки: at 12 and 24 weeks follow-up]
• Anxiety [Срок оценки: at 12 and 24 weeks follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Бельгия · 2 центра

• Antwerp University Hospital — Edegem
• University Hospital Leuven — Leuven

Идентификаторы

NCT: NCT06962579 · 6776 · Edge 3857 · S69491

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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