Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
Launched by RIPHAH INTERNATIONAL UNIVERSITY · Dec 12, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a type of exercise called Sensorimotor training can help breast cancer patients who are experiencing a common side effect of chemotherapy known as Chemotherapy-Induced Peripheral Neuropathy (CIPN). CIPN can cause pain, balance issues, and difficulty with physical activities, affecting about 30-70% of women undergoing chemotherapy for breast cancer. The researchers want to see if this specific training can reduce pain, improve balance confidence, and enhance overall physical ability in those dealing with these symptoms.
To participate in the trial, women must be between 30 and 65 years old, have been diagnosed with early-stage invasive ductal breast cancer within the last 3 to 6 months, and have completed their chemotherapy treatment. They should also be experiencing symptoms of CIPN. Participants will undergo assessments to measure their pain and balance before and after the training. It's important to note that women with other types of cancer, certain chronic health issues, or unstable bone metastases are not eligible for this study. If you or someone you know fits these criteria and is interested, this trial could offer valuable support in managing CIPN symptoms.
Gender
FEMALE
Eligibility 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
About Riphah International University
Riphah International University is a leading educational institution based in Pakistan, dedicated to advancing healthcare and medical research through innovative clinical trials. With a commitment to excellence in research and education, Riphah emphasizes ethical standards and scientific integrity in its clinical studies. The university collaborates with various stakeholders, including healthcare professionals and industry partners, to enhance patient outcomes and contribute to the global body of medical knowledge. Through its robust research programs, Riphah International University aims to foster a culture of inquiry and improve healthcare delivery both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lahore, Punjab, Pakistan
Lahore, Punjab, Pakistan
Patients applied
Trial Officials
Muhammad Asrar Yousaf, M.phil
Principal Investigator
Riphah International University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported