Exercise Intervention for Chemotherapy-Induced Peripheral Neuropathy

NCT07635901 | Completed DMC

• 1 other identifier: 05/185
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of chemotherapy that can negatively impact patients' functional status and quality of life. This study was conducted in two phases among oncology patients receiving chemotherapy at a tertiary care teaching hospital in Chennai, India. Phase I used a descriptive survey design to determine the prevalence of CIPN. Phase II employed a randomized controlled experimental design to evaluate the effectiveness of a structured exercise program in reducing CIPN symptoms among patients with mild to moderate CIPN. Eligible participants were randomly assigned to intervention and control groups. The intervention group received education and supervised exercises involving lower and upper extremity movements, while the control group received routine care. Outcomes were assessed using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale before and after a 21-day intervention period.

Conditions

Neuropathy; Oncology; Exercise; Patients on Chemotherapy; Effectiveness

Keywords

Chemotherapy-Induced Peripheral Neuropathy; Exercise Therapy; Oncology Patients; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Severity of Chemotherapy-Induced Peripheral Neuropathy

  Change in CIPN severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.

  Baseline and Day 21

Secondary Outcomes (1)

• Prevalence of Chemotherapy-Induced Peripheral Neuropathy among oncology patients receiving chemotherapy.

  At baseline assessment.

Study Arms (2)

Experimental Arm: Structured Exercise Program

EXPERIMENTAL

Participants received structured education regarding chemotherapy-induced peripheral neuropathy and performed a supervised exercise program involving lower and upper extremity exercises for 21 days in addition to routine care.

Behavioral: Structured exercise program for CIPN

Control Arm: Routine Care

NO INTERVENTION

Participants received standard oncology care including consultation and medication management according to institutional protocols.

Interventions

Structured exercise program for CIPN BEHAVIORAL

Patients in the intervention group receive structured education about CIPN, which included its definition, risk factors, signs and symptoms, and management through exercises. The exercises were demonstrated by the researcher and involved leg toe flexion and extension, ankle circles, toe spreading, heel raises, as well as hand exercises such as finger extension stretches, pinch grips, and finger circles. Participants were asked to return demonstrate the exercises, continue practicing them under supervision for one to two days during hospitalization for chemotherapy and after discharge for a period of 21 days when they came for their subsequent cycle of chemotherapy. This was then reinforced using a pamphlet which was provided to the patients, and patients were encouraged to maintain a daily practice

Experimental Arm: Structured Exercise Program

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than 18 years
• Receiving chemotherapy
• Diagnosed with mild or moderate chemotherapy-induced peripheral neuropathy
• Willing to participate and provide informed consent

You may not qualify if:

• Pre-existing peripheral neuropathy unrelated to chemotherapy (e.g., diabetic neuropathy).
• Uncontrolled diabetes mellitus.
• Significant cardiovascular disease.
• Severe musculoskeletal disorders.
• Contraindications to exercise, including recent surgery, bone metastases, or severe anemia.
• Severe mobility limitations.
• Severe mental health conditions affecting participation.

Sponsors & Collaborators

• Sri Ramachandra Institute of Higher Education and Research: lead

Study Sites (1)

Sri Ramachandra Institute of Higher Education and Research

Chennai, Tamil Nadu, 600116, India

Location

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. A.Seethalakshmi, Principal Investigator, Professor and Head of the Department, Department of Nursing Foundation

Model Details: The study employed a randomized, parallel-assignment intervention model with an open-label design, and its primary purpose was treatment. Phase I consisted of a prevalence survey involving 282 oncology patients to determine the prevalence of chemotherapy-induced peripheral neuropathy (CIPN). Phase II included 120 patients with mild to moderate CIPN who were randomly assigned to either the study group or the control group to evaluate the effectiveness of an exercise intervention on CIPN symptoms.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)