Flaxseed, Aromatase Inhibitors and Breast Tumor Characteristics

NCT00612560 | Completed Results DMC

• 3 other identifiers: I 99507I99507R21AT004024-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study plans to examine the effect of flaxseed consumption, a phytoestrogen rich food, compared to aromatase inhibitors as a complementary approach to treating estrogen receptor positive breast cancer, as well as the effect of combined flaxseed and aromatase inhibitor therapy on breast cancer treatment. Because of the increasing use of both complementary and alternative approaches to treatment, and the use of aromatase inhibitors in the treatment of breast cancer, the proposed study has potential to provide important clinical information about the effect of foods high in phytoestrogens on a common endocrine therapy used in breast cancer.

Conditions

Breast Cancer

Keywords

breast neoplasms; phytoestrogens; tumor characteristics; proliferation; apoptosis; estrogen receptor; HER2

Outcome Measures

Primary Outcomes (3)

• Expression of Estrogen Receptor (ER-beta)

  Mean percentage of cells expressing estrogen receptor (ER-beta)

  Biopsy/Week 1 and Surgical Resection/Week 2

• Progesterone Receptor (PR) Expression

  Mean percentage of cells expressing PR

  Biopsy/Week 1 and Surgical Resection/Week 2

• Human Epidermal Growth Factor Receptor 2 (Her2) Expression

  Mean percentage of cells expressing human epidermal growth factor receptor 2 (Her2)

  Biopsy/Week 1 and Surgical Resection/Week 2

Secondary Outcomes (1)

• Growth Hormone Serum Levels IGF-1

  Biopsy/Week 1 and Surgical Resection/Week 2

Study Arms (4)

2

EXPERIMENTAL

Flaxseed 25 mg per day and 1 placebo pill per day

Dietary Supplement: flaxseed

3

EXPERIMENTAL

25 mg flaxseed per day and 1 mg anastrozole pill per day

Drug: Anastrozole; Dietary Supplement: flaxseed

4

PLACEBO COMPARATOR

Placebo pill 1 per day

Drug: Placebo

1

EXPERIMENTAL

Anastrozole 1 mg pill per day

Drug: Anastrozole

Interventions

Anastrozole DRUG

1 mg per day

Also known as: Arimidex

1; 3

flaxseed DIETARY_SUPPLEMENT

25 g per day ground

2; 3

Placebo DRUG

Placebo pill 1 per day

4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 85 years
• Postmenopausal status defined as: no menstrual cycle in the past 12 months hysterectomy with bilateral oophorectomy hysterectomy with intact ovaries if age \> 55 years
• Newly diagnosed with incident, primary, invasive, estrogen receptor positive clinical stage II or lower breast cancer
• ECOG performance status of 1 or less
• Willingness to comply with study guidelines and procedures
• Willingness and ability to provide informed consent
• Usual consumption of soy no more than 1 time per week and willingness to avoid whole soy foods or concentrated soy sources (soy milk, tofu, substitute meat products, meal replacement bars) during the intervention period
• Willingness to avoid herbal and dietary supplements (not including vitamins), aspirin, and ibuprofen during the intervention period
• No competing neoadjuvant or chemotherapy treatment
• Time between pre-surgical visit and surgery must be at least 2 weeks
• No chemotherapy in the past 12 months

You may not qualify if:

• Inability to read and write English
• Previous invasive breast cancer
• Insulin dependent Type I or II diabetes diagnosed by physician
• History of coagulopathy, thrombocytopenia, or bleeding disorder
• Current (past 30 days) regular (at least once per week) use of reproductive hormone therapy, Tamoxifen, aromatase inhibitors, or other estrogen inhibitors, flaxseed, or antibiotics
• Current chemotherapy or neoadjuvant chemotherapy
• Allergies to flaxseed, nuts, or other seeds
• Renal dysfunction defined as creatinine \> 1.5 mg/dl
• History of Crohns' disease, ulcerative colitis, irritable bowel syndrome, celiac sprue, or other malabsorption syndrome, diverticulitis, diverticulosis, or other bowel diagnosis which, in the opinion of the breast surgeon, would contraindicate large doses of dietary fiber or would impair nutrient absorption
• Current, regular (more than once weekly) use of prescription blood-thinning agents including coumadin, heparin and heparin related drugs, clopidogrel bisulfate

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• AstraZeneca: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (1)

• McCann SE, Edge SB, Hicks DG, Thompson LU, Morrison CD, Fetterly G, Andrews C, Clark K, Wilton J, Kulkarni S. A pilot study comparing the effect of flaxseed, aromatase inhibitor, and the combination on breast tumor biomarkers. Nutr Cancer. 2014;66(4):566-75. doi: 10.1080/01635581.2014.894097. Epub 2014 Mar 26.

  PMID: 24669750 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; Linseed Oil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Tracey L O'Connor, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 11, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2014
• Last Updated: October 12, 2017
• Results First Posted: August 16, 2017

Record last verified: 2017-09

Locations

US (1)