Exercise and Mindfulness Intervention for Chemotherapy-Induced Peripheral Neuropathy in Patients With Cancer

Официальное название

Effect of an Exercise- and Mindfulness-Based Cognitive Therapy Intervention on Physical and Psychological Symptoms in Cancer Patients With Chemotherapy-Induced Peripheral Neuropathy

Обзор

The goal of this clinical trial is to learn whether an exercise- and mindfulness-based cognitive therapy intervention can improve physical and psychological symptoms in cancer patients with chemotherapy-induced peripheral neuropathy. It will also examine whether this intervention can improve quality of life. The main questions it aims to answer are: Can this intervention reduce physical symptoms related to chemotherapy-induced peripheral neuropathy? Can this intervention reduce psychological symptoms in affected patients? Can this intervention improve patients' quality of life? Participants will: Follow a structured program of regular exercise and mindfulness practice Undergo weekly assessments of symptom changes Keep records of their symptom changes during the intervention period

Вмешательства

• Поведенческое Exercise and Mindfulness
  Participants in the intervention group will receive a structured exercise- and mindfulness-based cognitive therapy program. This combined behavioral intervention includes two integrated components: (1) exercise training, consisting of aerobic exercise and resistance training, performed 3-5 times per week for 20-30 minutes per session; and (2) mindfulness practice, consisting of mindfulness breathing, body scan, and mindful walking, performed daily for 10-15 minutes per session. Unlike routine ca

Первичные конечные точки

• Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy. [Срок оценки: Baseline, 6 weeks and 3 months.]

Критерии участия

Критерии включения

• Patients with a pathologically confirmed malignant tumor;
• Currently receiving neurotoxic chemotherapy and experiencing chemotherapy-induced peripheral neuropathy (CIPN);
• Cancer stage Tis or stage I-III;
• Aged 18 years or older, with normal consciousness, mental status, and verbal communication ability; able to understand and judge their own sensations and general condition; and able to complete the questionnaires;
• Willing to participate in the study and able to provide written informed consent;
• Patients with NCI-CTCAE grade <2 who are considered suitable for exercise intervention.

Критерии исключения

• Presence of other neurological diseases or severe psychiatric disorders;
• Presence of other serious illnesses, such as severe heart disease or respiratory failure;
• Inability to understand or complete the questionnaires;
• Participation in psychological counseling, psychotherapy, or other clinical trials within the past 6 months;
• Inability or expected inability to complete the full 6-week intervention.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07556965 · 〔2025〕126

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗