NCT06737926 Effects of Sensorimotor Training With Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Patients
| NCT ID | NCT06737926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Riphah International University |
| Condition | Chemotherapy Induced Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-01-15 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chemotherapy-Induced Peripheral Neuropathy (CIPN) is a prevalent and clinically relevant side effect of chemotherapy in breast cancer patients. It occurs in 30-70% of cases. It can cause various sensory and motor symptoms. Specific exercise interventions have proven promising to target relevant symptoms. Therefore, the objective of this study is to determine the effects of Sensorimotor training on pain intensity, perceived balance confidence, and functional exercise capacity with chemotherapy-induced peripheral neuropathy in breast cancer patients.
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
Contact & Investigator
Muhammad Asrar Yousaf, M.phil
PRINCIPAL INVESTIGATOR
Riphah International University
Frequently Asked Questions
Who can join the NCT06737926 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 65 Years, studying Chemotherapy Induced Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06737926 currently recruiting?
Yes, NCT06737926 is actively recruiting participants. Contact the research team at imran.amjad@riphah.edu.pk for enrollment information.
Where is the NCT06737926 trial being conducted?
This trial is being conducted at Lahore, Pakistan, Lahore, Pakistan.
Who is sponsoring the NCT06737926 clinical trial?
NCT06737926 is sponsored by Riphah International University. The principal investigator is Muhammad Asrar Yousaf, M.phil at Riphah International University. The trial plans to enroll 24 participants.