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

N/ANot Yet RecruitingNCT07556965

Nanjing Medical University40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer Patients Chemotherapy-Induced Peripheral Neuropathy Exercise Intervention

Exercise and MindfulnessBEHAVIORAL

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 care or single-component interventions, this program combines physical exercise with mindfulness practice to target both physical and psychological symptoms associated with chemotherapy-induced peripheral neuropathy. Weekly symptom assessments and symptom change records will be completed during the intervention period.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy.

The degree of change from baseline after the intervention (using the Treatment-Induced Neuropathy Assessment Scale (TNAS) to assess patients' CIPN-related physical symptom burden. The scale consists of 9 items, each scored from 0 to 10, with higher scores indicating a greater symptom burden. The Kessler Psychological Distress Scale (K10) was used to assess the level of psychological distress. The scale consists of 10 items, rated on a 5-point scale, with higher total scores indicating more severe psychological distress.)

Time frame: Baseline, 6 weeks and 3 months.