Status:
RECRUITING
Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: A Randomized Controlled Trial
Lead Sponsor:
Al Hayah University In Cairo
Conditions:
Breast Cancer
Breast Cancer Female
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This multi-center randomized controlled trial (RCT) evaluates the long-term (12-month) effectiveness of a standardized multidisciplinary physiotherapy program versus standard care on persistent pain, ...
Detailed Description
Breast cancer survivors frequently experience persistent pain, upper limb dysfunction, and CRF well into the survivorship phase, even after completion of acute treatment. Despite various studies evalu...
Eligibility Criteria
Inclusion
- Women aged between 18 and 65 years. History of breast cancer surgery (with or without axillary lymph node dissection).
- Completed acute cancer treatment (surgery, chemotherapy, and/or radiation) at least 6 months prior to enrollment.
- Currently in the survivorship phase, with no active evidence of disease.
- Experiencing persistent sequelae related to treatment, such as:
- Moderate to severe pain (e.g., VAS score ≥ 30 on a 0-100 scale), and/or Upper limb dysfunction, and/or Cancer-related fatigue (as measured by FACIT-Fatigue). Able to understand and provide written informed consent.
Exclusion
- Diagnosis of recurrent or metastatic breast cancer. Currently receiving active cancer treatment (chemotherapy, radiation for active disease, or immunotherapy).
- Participation in another interventional trial targeting pain or rehabilitation within the past 3 months.
- Presence of severe comorbidities (e.g., uncontrolled cardiovascular disease, severe orthopedic or neurological conditions) that would preclude safe participation in physiotherapy.
- Any physical or psychological condition that, in the opinion of the investigator, would interfere with participation or adherence to the study protocol (e.g., severe cognitive impairment).
- Pregnancy or breastfeeding.
Key Trial Info
Start Date :
April 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06913244
Start Date
April 23 2025
End Date
January 1 2027
Last Update
April 6 2025
Active Locations (1)
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1
Faculty of Physical Therapy, Al Hayah University
Cairo, Egypt, 12311