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

NCT07556965 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-07-17
Last updated
2026-09-29

Condition(s) studied

Cancer PatientsChemotherapy-Induced Peripheral NeuropathyExercise Intervention

Investigational drug(s) / intervention(s)

Exercise and Mindfulness

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 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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Severity of physical symptoms and degree of psychological distress in chemotherapy-induced peripheral neuropathy. — Baseline, 6 weeks and 3 months.
    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.)

Trial sites (2)

FacilityCityRegionStatus
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Guangzhou Road Campus Nanjing Jiangsu
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital), Longjiang Campus Nanjing Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07556965 on ClinicalTrials.gov ↗ ← All trials in China