Long-Term Multidisciplinary Physiotherapy for Breast Cancer Survivors: A Randomized Controlled Trial
Recruiting · NCT06913244 · Interventional (participants receive a specific treatment) · Lead sponsor: Al Hayah University In Cairo
View the official record on ClinicalTrials.gov →Interventions studied
Multidisciplinary Physiotherapy Program (MD Physio)Standard Physiotherapy Care
What this trial is about
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, upper limb (UL) dysfunction, and cancer-related fatigue (CRF) in breast cancer survivors. The study also examines improvements in quality of life and psychological well-being. The standardized intervention combines specific exercise therapy, manual therapy, education, and mind-body interventions and is designed to produce sustained benefits beyond the acute rehabilitation phase.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Faculty of Physical Therapy, Al Hayah University - Cairo, Egypt