Sensorimotor training for breast cancer patients with chemotherapy-induced peripheral neuropathy
Effects of Sensorimotor Training on Pain Intensity, Perceived Balance Confidence and Functional Exercise Capacity With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
This study tests if sensorimotor training can help breast cancer patients with nerve pain from chemotherapy feel better and improve their balance and exercise ability.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | Female |
| Sponsor | Riphah International University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Lahore, Punjab Province and 1 other locations) |
| Trial ID | NCT06737926 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of sensorimotor training on breast cancer patients suffering from chemotherapy-induced peripheral neuropathy (CIPN). It involves a randomized controlled trial with 22 participants who are divided into an experimental group performing sensorimotor exercises and a control group engaging in conventional exercises. The training focuses on improving pain intensity, balance confidence, and functional exercise capacity over a period of six weeks. Assessments are conducted before and after the intervention using various scales to measure outcomes related to pain, balance, and quality of life.
Who should consider this trial
Good fit: Ideal candidates are females aged 30-65 with invasive ductal carcinoma stages I-III, who are 3-6 months post-diagnosis and have completed chemotherapy.
Not a fit: Patients who are not experiencing CIPN symptoms or those with severe balance impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce pain and improve balance and functional capacity in breast cancer patients experiencing CIPN.
How similar studies have performed: Other studies have shown promising results with exercise interventions for CIPN, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Females with invasive ductal carcinoma, stages I-III * Age ranged between 30-65 years * 3-6 months post breast cancer diagnosis * Those who have completed chemotherapy treatment and are medically stable * CIPN symptoms as subjectively assessed by FACT/GOG-Ntx. Score ranges from 0-44 (5). 0 - 10: Minimal or no neurotoxicity symptoms, 11 - 20: Mild neurotoxicity symptoms, 21 - 30: Moderate neurotoxicity symptoms, 31 - 40: Severe neurotoxicity symptoms, 41 - 44: Very severe neurotoxicity symptoms * For balance testing Fullerton Advanced Balance (FAB) scale was used. 0-19 = high risk of falls, 20-29 = moderate balance impairment, 30-40 = good balance. The cut off value is ≤ 25/40 Points. * Objective neurological testing such as Achilles and patellar tendon reflexes (1 = agile, 2 = weak, 3 = missing), peripheral deep sensitivity (0=no sensitivity to 8=highest sensitivity), light touch perception (symmetrical or impaired), sense of position (1 = position recognized, 2 = only position of knee recognized, and 3 = no recognition) and lower leg strength (0 = no activity to 5 = normal force) rated on a Likert-scale Exclusion Criteria: * Women with additional types of cancer besides breast cancer * Chronic medical conditions such as poorly controlled diabetes (6) * Significant neurological (multiple sclerosis) or cardiopulmonary disease (myocardial infarction \< 3 months) that may affect performance (6) * Unstable bone metastasis
Where this trial is running
Lahore, Punjab Province and 1 other locations
- Mayo Hospital Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
- Mayo Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Muhammad Asrar Yousaf, M.phil — Riphah International University
- Study coordinator: Imran Amjad, PHD
- Email: imran.amjad@riphah.edu.pk
- Phone: 03324390125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.