Breast Cancer Clinical Trial
Official title:
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
Exercise in early breast cancer patients has the potential to improve depression, anxiety, fatigue, quality of life and even survival. The effects of exercise may come about by way of changes in weight, immune markers and telomere length, but data on this so far has not been conclusive. To better understand the physical, psychological, and biological effects of exercise on breast cancer survivorship, the investigators propose to perform a phase III randomized controlled trial of a 12-week exercise intervention program versus usual care in early stage breast cancer patients, and will follow up the patients prospectively for 5 years, with serial assessment of physical and functional activity, QoL, depression and anxiety scores, telomere length and plasma immune markers.
Status | Recruiting |
Enrollment | 304 |
Est. completion date | December 20, 2025 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital, Singapore | Singapore | |
Singapore | Ng Teng Fong General Hospital | Singapore | |
Singapore | Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore |
Singapore,
Carayol M, Bernard P, Boiché J, Riou F, Mercier B, Cousson-Gélie F, Romain AJ, Delpierre C, Ninot G. Psychological effect of exercise in women with breast cancer receiving adjuvant therapy: what is the optimal dose needed? Ann Oncol. 2013 Feb;24(2):291-300. doi: 10.1093/annonc/mds342. Epub 2012 Oct 5. Review. — View Citation
Kolden GG, Strauman TJ, Ward A, Kuta J, Woods TE, Schneider KL, Heerey E, Sanborn L, Burt C, Millbrandt L, Kalin NH, Stewart JA, Mullen B. A pilot study of group exercise training (GET) for women with primary breast cancer: feasibility and health benefits. Psychooncology. 2002 Sep-Oct;11(5):447-56. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improved mental health | Based on the HADS (Hospital Anxiety and Depression Scale) questionnaire, we define a score of =8/21 as caseness for anxiety or depression | 12 months | |
Secondary | Adherence rate | Subjects are considered to have adhered to the 12-week exercise regimen if they have completed at least 20 scheduled sessions over a period of no longer than 16 weeks | 16 weeks |
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