Effectiveness, Exercise, Neuropathy, Oncology, Patients on Chemotherapy
Conditions
Keywords
Chemotherapy-Induced Peripheral Neuropathy, Exercise Therapy, Oncology Patients, Randomized Controlled Trial
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.
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.
Interventions
BEHAVIORALStructured exercise program for CIPN
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
Sponsors
Sri Ramachandra Institute of Higher Education and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Chemotherapy-Induced Peripheral Neuropathy | Baseline and Day 21 | Change in CIPN severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Chemotherapy-Induced Peripheral Neuropathy among oncology patients receiving chemotherapy. | At baseline assessment. | Prescence of CIPN and its severity score measured using the Chemotherapy-Induced Peripheral Neuropathy Assessment Scale from baseline to Day 21. |
Countries
India
Outcome results
None listed