Can a short workout before breast cancer surgery change tumor markers?
NCT ID NCT01516190
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at women with newly diagnosed breast cancer who take part in exercise or mind-body programs for 3-6 weeks before their surgery. Researchers want to see if these programs help reduce stress, anxiety, and improve mood and quality of life. They also check for changes in tumor growth markers and blood hormones linked to breast cancer. The study does not provide treatment and will not share individual test results with participants.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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49 people
The number who actually took part.
- Started
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Aug 2011
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Other studies related to the condition(s) this trial covers.
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