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

NCT07556965 | Not Yet Recruiting

• 1 other identifier: 〔2025〕126
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Exercise Intervention; Cancer Patients; Chemotherapy-Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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.)

  Baseline, 6 weeks and 3 months.

Study Arms (1)

Routine nursing.

EXPERIMENTAL

The intervention group will receive an exercise- and mindfulness-based cognitive therapy program. Exercise training will include aerobic exercise and resistance training, conducted 3-5 times per week for 20-30 minutes per session. Mindfulness practice will include mindfulness breathing, body scan, and mindful walking, conducted daily for 10-15 minutes per session.

Behavioral: Exercise and Mindfulness

Interventions

Exercise and Mindfulness BEHAVIORAL

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.

Routine nursing.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Medical University: lead

MeSH Terms

Interventions

Exercise; Mindfulness

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04