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NCT Number: NCT07635901

Exercise Intervention for Chemotherapy-Induced Peripheral Neuropathy

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.

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Key information

Conditions

Neuropathy Behavior Effectiveness Exercise Motor Activity Neoplasms Oncology Patients on Chemotherapy

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sri Ramachandra Institute of Higher Education and Research

Chennai, Tamil Nadu, 600116, India

About this study

This quantitative study was conducted in two phases. Phase I assessed the prevalence of chemotherapy-induced peripheral neuropathy among oncology patients receiving chemotherapy. A total of 282 participants were enrolled.

Based on the prevalence findings, Phase II was conducted to determine the effectiveness of a structured exercise program. One hundred and twenty patients with mild or moderate CIPN were randomly allocated into intervention (n=60) and control (n=60) groups using a lottery method. The intervention consisted of education regarding CIPN and a structured exercise program including toe flexion and extension, ankle circles, toe spreading, heel raises, finger extension stretches, pinch grips, and finger circles. Exercises were performed 10-15 repetitions per extremity, 2-3 times daily, for 21 days.

Participants in the control group received routine oncology care. CIPN severity was measured before and after the intervention using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale. Statistical analyses included descriptive statistics, paired t-tests, independent t-tests, and chi-square tests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Severity of Chemotherapy-Induced Peripheral Neuropathy

    Time frame: Baseline and Day 21

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

Secondary outcomes

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

    Time frame: At baseline assessment.

    Prescence of CIPN and its severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21.

Sponsors and collaborators

Lead sponsor

Sri Ramachandra Institute of Higher Education and Research

Other

Registry information

Official study title

Prevalence and Effectiveness of Exercise on Chemotherapy-induced Peripheral Neuropathy Among Oncology Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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