Status:
ACTIVE_NOT_RECRUITING
The Preoperative Health & Body Study
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Yale University
Susan G. Komen Breast Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study is designed to look at the changes that occur in women who take part in exercise and Mind-Body programs between breast cancer diagnosis and breast surgery. The investigators will look at ch...
Eligibility Criteria
Inclusion
- Newly diagnosed, histologically confirmed stage I-III breast cancer
- Planning to undergo definitive surgical management with lumpectomy or mastectomy with in the next 8 weeks.
- Willing and able to participate in the intervention for at least 3 weeks prior to surgery.
- ECOG performance status of 0 or 1
- Approval by oncologist or surgeon
- Willingness to be randomized.
- English speaking and able to read English
Exclusion
- Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in situ cervical cancer)
- Presence of metastatic disease
- Scheduled to receive any form of neoadjuvant cancer therapy
- Locally advanced breast cancer not amenable to primary surgery
- History of prior ipsilateral breast cancer
- Taking tamoxifen, raloxifene or an aromatase inhibitor at the time of breast cancer diagnosis
- Absolute contraindications to maximal exercise testing as recommended by the American Thoracic Society
- Any condition which in the investigator's opinion makes the subject unsuitable for study participation
- Participating in another clinical study with competing study outcomes
- Pregnant (i.e., positive beta-HCG) or breast feeding
- Unable to comply with protocol and/or not available for follow-up assessments
- Participation in more than 90 minutes a week of moderate-intensity recreational activity (not including activities such as gardening, bowling, golfing with a cart) as assessed by the Leisure Score Index of Godin Leisure- Time Exercise Questionnaire (LSI) (Appendix I) or recent participation (past 6 months) in two or more strength training sessions per week.
- Diabetes mellitus requiring insulin or oral agents; patients with diet-controlled diabetes will be allowed to participate
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01516190
Start Date
August 1 2011
End Date
September 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215