- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07635901
Exercise Intervention for Chemotherapy-Induced Peripheral Neuropathy
Prevalence and Effectiveness of Exercise on Chemotherapy-induced Peripheral Neuropathy Among Oncology Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India, 600116
- Sri Ramachandra Institute of Higher Education and Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Arm: Structured Exercise Program
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.
|
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
|
|
No Intervention: Control Arm: Routine Care
Participants received standard oncology care including consultation and medication management according to institutional protocols.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At baseline assessment.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/185
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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