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

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Exercise
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
National University Hospital, Singapore
RECRUITING
Singapore
Ng Teng Fong General Hospital
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Contact Information
Primary
Soo Chin Lee
soo_chin_lee@nuhs.edu.sg
(65) 6779 5555
Backup
Andrea Wong
andrea_la_wong@nuhs.edu.sg
(65) 6779 5555
Time Frame
Start Date: 2015-03-12
Estimated Completion Date: 2025-12-20
Participants
Target number of participants: 304
Treatments
Experimental: Exercise intervention
Patients who are randomised to this arm will be enrolled to the exercise programme.
No_intervention: Non-exercise
Patients who are randomised to the non-exercise group can continue their daily and physical activities as they normally would.
Related Therapeutic Areas
Sponsors
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov