Stage IIIA Breast Cancer Clinical Trial
Official title:
A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease
Verified date | December 2021 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | April 22, 2020 |
Est. primary completion date | January 11, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 >= 75,000/uL - White blood cells >= 3,000/uL - Hemoglobin >= 10 g/dL - Total bilirubin within 1.5 times the institution's upper limit of normal (ULN) - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) within 1.5 times the institution's ULN - Serum creatinine within 1.5 times the institution's ULN - Pregnant women will be excluded; for women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy - Willingness to comply with all study interventions and follow-up procedures including the ability to swallow the study drug - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Any type of active invasive cancer (excluding breast and non-melanoma skin cancer) within the preceding 18 months - A history of histologically-confirmed bilateral invasive breast cancer - Bilateral mastectomy - Prior history or evidence of metastatic breast cancer - Prior radiation therapy to the contralateral (unaffected) breast - Prior history of contralateral (unaffected) breast augmentation with breast implant placement - History of daily use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) in the week preceding study entry - History of DHA supplementation > 200 mg/day in the month preceding study entry - History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators - History of therapeutic doses of anticoagulants including warfarin and low molecular weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolism) in the preceding year - Participants may not be receiving any other investigational agents during the study - Women who have received cancer surgery, chemotherapy, biological therapy (e.g., trastuzumab), or radiotherapy for the treatment of any cancer within 6 months of study participation - Women who are receiving endocrine therapy for breast cancer treatment or chemoprevention including tamoxifen, letrozole, anastrozole, fulvestrant, or exemestane at the time of screening - Individuals with severe underlying chronic illness, such as uncontrolled diabetes; ongoing or active infection, psychiatric illness or social situations which in the opinion of the investigator would interfere with study participation - History of allergic reactions attributed to compounds of similar chemical or biologic composition to DHA or corn/soy oil in placebo agent - Pregnant, breastfeeding, or women of childbearing potential unwilling to use a reliable contraceptive method |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Columbia University/Herbert Irving Cancer Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Normal Breast Tissue Expression of Tumor Necrosis Factor Alpha (TNF-alpha) Levels | Differences in normal breast tissue levels of TNF-a 12 weeks post-treatment relative to pre-treatment for active treatment and placebo arm, compared using analysis of covariance where the post-treatment measurements were used as a dependent variable and the pretreatment measurements were included as a covariate in the analysis. For the primary study end-point TNF-a levels will be measured by quantitative real-time PCR (mRNA essays) on extracted RNA from breast core biopsies. Relative expression determined using the Computed Tomography (??CT) analysis protocol. | Baseline to 12 weeks | |
Secondary | Number of Participants With Crown-like Structures of the Breast (CLS-B) at Baseline and Post-treatment | An indicator of whether a subject is detected with CLS-B or not. | Baseline to 12 weeks | |
Secondary | Absolute Change in CLS-B/cm^2 Adjusted for the Pre-treatment Measurements | To assess the severity of CLS-B using the following formula: number of CLS-B/cm^2. The absolute change in the CLS-B/cm^2 calculated according to the formula; Change in CLS-B/cm^2 = (post-treatment CLS-B/cm^2) - (pre-treatment CLS-B/cm^2). | Baseline to 12 weeks | |
Secondary | Breast Tissue Cox 2 mRNA Levels at Baseline and 12 Weeks | Biomarkers COX-2 are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis. | Baseline to 12 weeks | |
Secondary | Mean Difference in the Breast Tissue IL- Beta mRNA Levels of Tissue Biomarkers | Biomarkers IL-1Beta are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis. | Baseline to 12 weeks | |
Secondary | Mean Difference in the Breast Tissue Aromatase mRNA Levels of Tissue Biomarkers | Biomarkers Aromatase are measured by quantitative real-time PCR. Differences between active treatment and placebo arm for each biomarker will be compared using analysis of covariance where the post treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis. | Baseline and 12 weeks | |
Secondary | Red Blood Cell (RBC) Fatty Acid Level as a Surrogate of Compliance | Whole blood samples collected for red blood cell fatty acid analyses at baseline and week 12 (+ 2 weeks). RBC fatty acid composition analyzed by gas chromatography (GC) with flame ionization detection. | Baseline and week 12 |
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