Effect of Exercise on Chemotherapy-Induced Peripheral Neuropathy

NCT07399561 | Not Yet Recruiting DMC

• 1 other identifier: NCC-CIPN-EX-2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often persistent adverse effect of oxaliplatin- and paclitaxel-based chemotherapy. While exercise is frequently recommended for patients with CIPN, it remains unclear whether exercise mitigates neuropathic injury itself or primarily improves physical function and quality of life. This randomized controlled trial evaluates the effects of exercise on CIPN during and after chemotherapy. Patients receiving oxaliplatin for colorectal cancer or paclitaxel for gynecologic cancer are randomized to an exercise intervention or usual-care control. Neuropathy severity is assessed using objective neurophysiological measures, blood biomarkers, and validated clinical and patient-reported outcomes.

Conditions

Peripheral Neuropathy, Secondary to Drugs or Chemicals; Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients; Paclitaxel Induced Neuropathy

Keywords

chemotherapy induced peripheral neuropathy; CIPN; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Chemotherapy-Induced Peripheral Neuropathy Severity (CTCAE v5.0)

  Change in chemotherapy-induced peripheral neuropathy severity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 sensory neuropathy grade (Grade 0-4, with higher grades indicating more severe neuropathy).

  Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.

Secondary Outcomes (14)

• Blood Biomarkers

  Baseline, end of chemotherapy, 3 months post-chemotherapy

• Quality of Life Assessed by EORTC QLQ-C30

  Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.

• Change in Timed Up and Go Test Performance

  Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.

• Change in Sensory Nerve Action Potential Amplitude

  Baseline (prior to initiation of chemotherapy), end of chemotherapy (up to approximately 24 weeks after chemotherapy initiation), and 3 months after completion of chemotherapy.

• Change in Patient-Reported CIPN Symptoms Assessed by EORTC QLQ-CIPN20

  Baseline, end of chemotherapy (up to approximately 24 weeks), and 3 months after completion of chemotherapy.

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

Participants assigned to this arm will perform a structured home-based exercise program during chemotherapy and for up to three months after completion of chemotherapy. The exercise program is designed to be safe and feasible during active cancer treatment and includes aerobic and strengthening components. Participants receive standardized exercise education materials, and adherence and safety are monitored through regular telephone follow-up.

Behavioral: Exercise Intervention

Usual Care

ACTIVE COMPARATOR

Participants assigned to this arm will receive standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy. No structured exercise program is prescribed during the study period.

Other: Usual Care

Interventions

Exercise Intervention BEHAVIORAL

A structured home-based exercise program performed during chemotherapy and for up to three months after completion of chemotherapy. The program includes aerobic and strengthening exercises and is designed to be safe and feasible during active cancer treatment. Adherence is monitored through regular telephone follow-up.

Exercise Intervention

Usual Care OTHER

Standard oncologic care and general education regarding chemotherapy-induced peripheral neuropathy, without a structured exercise program.

Usual Care

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of colorectal cancer (oxaliplatin cohort) or gynecologic cancer (paclitaxel cohort)
• Planned initiation of oxaliplatin- or paclitaxel-based chemotherapy
• Karnofsky Performance Status ≥70
• Ability to provide written informed consent

You may not qualify if:

• Pre-existing peripheral neuropathy from other causes
• Severe comorbidities limiting safe participation in exercise
• Regular participation in a structured moderate- to high-intensity exercise program comparable to the study intervention prior to enrollment.
• Cognitive impairment interfering with study participation

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang, Gyeonngi, 10408, South Korea

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Behavior

Central Study Contacts

Su-Hyun Kim, MD, PhD

CONTACT

82-31-920-1683; herena20@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Neurology

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 10, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: Individual participant data will be shared upon reasonable request. Requests must include a methodologically sound proposal and be approved by the study investigators. Data will be shared after execution of a data sharing agreement, in accordance with institutional policies and applicable regulations.

Locations

KR (1)