Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors (NCT01849250) | Clinical Trial Compass
CompletedPhase 2
Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors
United States65 participantsStarted 2013-05
Plain-language summary
This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Participants must have a history of histologically-confirmed stage I-III invasive breast cancer or ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease
* No evidence of disease (in situ or invasive cancer that would normally be treated by resection) at trial entry as determined by the investigator
* \>= 6 months from all previous breast cancer treatment (including surgery for invasive cancer, chest wall radiotherapy, chemotherapy, trastuzumab and endocrine therapy)
* Participants must have a body mass index (BMI) \>= 25, defined as (weight in kilograms/\[height in meters\]\^2)
* Participants must have adequate accessible breast tissue as determined by the treating physician, consisting of one breast unaffected by invasive cancer, which has not been radiated; a history of prior pre-invasive breast cancer or benign biopsy of this breast will be permitted
* Daily DHA consumption =\< 200 mg/day in the month prior to screening estimated by an abbreviated DHA food frequency questionnaire
* Mammogram within no more than 6 months prior to the date of informed consent (normal/benign Breast Imaging-Reporting and Data System \[BI-RADS\] 1 or 2) and no further routine breast imaging planned during the course of the study (12 weeks DHA/placebo)
* Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2 (Karnofsky \>= 60%)
* Absolute neutrophil count \>= 1,500/uL
* Platelets \>= 7ā¦
What they're measuring
1
Normal Breast Tissue Expression of Tumor Necrosis Factor Alpha (TNF-alpha) Levels