Exercise program for early stage breast cancer patients
A Randomized Controlled Study of a 12-week Exercise Intervention Program Versus Observation in Early Stage Breast Cancer Patients on the Impact on Mental Health, Quality of Life and Immune Markers
This study tests whether a 12-week exercise program can help women with early stage breast cancer feel better mentally and physically compared to usual care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | Female |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Singapore and 2 other locations) |
| Trial ID | NCT03518957 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a 12-week exercise intervention program compared to usual care in early stage breast cancer patients. The study aims to assess the impact of exercise on mental health, quality of life, and immune markers over a five-year follow-up period. A total of 304 eligible female participants aged 21-70 years will be randomized into two groups, with assessments of physical activity, depression, anxiety, and biological markers conducted throughout the study. The trial seeks to provide insights into how exercise can influence survivorship outcomes in breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 21-70 with a diagnosis of stage I-III breast cancer who have undergone curative surgery.
Not a fit: Patients with cardiovascular, respiratory, or musculoskeletal issues that prevent moderate physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and quality of life for breast cancer survivors.
How similar studies have performed: Previous studies have shown promising results regarding the benefits of exercise in cancer survivorship, suggesting that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female * Age 21-70 years * Histological or cytological diagnosis of breast carcinoma * Stage I-III breast cancer * Has undergone curative breast cancer surgery with no clinically measurable tumor * Between 4-12 weeks from the last adjuvant radiotherapy or chemotherapy session, if given, whichever is later. Patients who do not receive adjuvant chemotherapy or radiotherapy can be enrolled and will be randomized within 4-12 weeks of breast cancer surgery. * Able to sign informed consent * Able to adhere to study procedures Exclusion Criteria: * Cardiovascular, respiratory, or musculoskeletal problems that preclude moderate physical activity * Major medical problems deemed by the investigator to be unsuitable for enrollment
Where this trial is running
Singapore and 2 other locations
- National University Hospital, Singapore — Singapore, Singapore (Recruiting)
- Tan Tock Seng Hospital — Singapore, Singapore (Recruiting)
- Ng Teng Fong General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Soo Chin Lee
- Email: soo_chin_lee@nuhs.edu.sg
- Phone: (65) 6779 5555
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.