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View Clinical Trial (Medical Research Study)
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Flaxseed in Treating Postmenopausal Women With Hot Flashes Who Have a History of Breast Cancer or Other Cancer or Who Do Not Wish to Take Estrogen Therapy - NCT00956813-46601B (Clinical Trial 422178)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy422178.aspx
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| City: |
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South Bend |
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State:
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IN |
| Zip Code: |
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46601 |
| Conditions: |
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Breast Cancer - Hot Flashes - Menopausal Symptoms - Unspecified Adult Solid Tumor, Protocol Specific |
| Purpose: |
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RATIONALE: Estrogen can relieve the symptoms of menopause, but can also cause the growth of
breast cancer cells. Flaxseed may reduce the number of hot flashes and improve mood and
quality of life in postmenopausal women not receiving estrogen therapy.
PURPOSE: This randomized phase III trial is studying flaxseed to see how well it works in
treating postmenopausal women with hot flashes who have a history of breast cancer or other
cancer or who do not wish to take estrogen therapy.
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| Study summary: |
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OBJECTIVES:
- To evaluate the efficacy of flaxseed on hot flash scores in women with a history of
breast cancer or other cancer or in women who do not wish to take estrogen therapy for
fear of increased risk of breast cancer as measured by a daily prospective hot flash
diary.
- To evaluate the side effect profile of flaxseed in this population.
- To evaluate the effects of flaxseed on mood (per the Profile of Mood States) and
broader menopausal symptoms (per the MENQOL), daily interference from hot flashes (per
the HFRDIS), and perception of benefit (per Global Impression of Change).
OUTLINE: Patients are stratified according to age (18-49 years vs ≥ 50 years); treatment
with tamoxifen citrate, selective estrogen receptor modulators, or aromatase inhibitors (yes
vs no); duration of hot flashes (≤ 9 months vs > 9 months); and daily frequency of hot
flashes (4-9 vs ≥ 10). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral flaxseed in the form of a bar similar to a granola bar
once daily.
- Arm II: Patients receive oral placebo bar once daily. In both arms, treatment continues
for 6-12 weeks. Patients in arm II may crossover to receive treatment as in arm I after
6 weeks.
Patients complete questionnaires (Hot Flash Diary, Side Effect Experience Questionnaire,
Profile of Mood States, Hot Flash Related Daily Interference Scale, and Menopause Specific
Quality of Life) at baseline and periodically during treatment. Patients are contacted by
telephone at the end of weeks 2, 4, 5, and 7 to assess product tolerability, document
compliance, encourage completion of questionnaires, and address problems. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Bothersome hot flashes, defined by their occurrence ≥ 28 times per week and of
sufficient severity to make the patient desire therapeutic intervention
- Presence of hot flashes for ≥ 1 month
- Meets 1 of the following criteria:
- History of breast cancer or other cancer (currently without malignant disease)
- No history of breast cancer and wishes to avoid estrogen due to a perceived
increased risk of breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Postmenopausal as defined by 1 of the following*:
- Absence of a period in the past 12 months
- Bilateral oophorectomy
- NOTE: *Women with ≥ 1 ovary but without a uterus should be deemed postmenopausal by
either age > 55 OR a combination of estrogen within a postmenopausal range (per local
lab) and follicle-stimulating hormone > 40 mIU/mL
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- Able to complete questionnaire(s) alone or with assistance
- No diabetes requiring oral or injectable antihyperglycemics
- No hypotension
- No history of allergic or other adverse reaction to flaxseed
- No irritable bowel syndrome, colitis, Crohn disease, or any gastrointestinal
condition where the patient should not consume and/or has an intolerance/allergies to
seeds or nuts
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or
progestational agents
- Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient
has been on a constant dose for ≥ 4 weeks and is not expected to stop the
medication during study treatment
- At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind
- Trastuzumab allowed
- No concurrent treatment with other anti-cancer therapies of any kind except for
trastuzumab or endocrine therapies
- No concurrent (≤ 7 days prior to registration) or planned use of other agents for
treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen
treatment, megestrol acetate, or Bellergal)
- Stable dose of vitamin E (as a general vitamin supplement) allowed provided it
is ≤ 800 IU/day, it was started > 30 days before study initiation, and is to be
continued through study period
- Patients who have been using antidepressants for mood and have been on a stable
dose for over a month and meet the eligibility criteria for hot flash frequency
and duration are eligible
- No concurrent anticoagulants or anti-platelets (1 mg of coumadin for central line
patency allowed)
- Aspirin allowed (≤ 81 mg)
- No concurrent anti-hypertensives
- No other concurrent herbal supplements for any reason, including soy and soy
supplements (i.e., powders, pills, or milk) |
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| Study is available at: |
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Memorial Hospital of South Bend
South Bend, IN 46601
United States
Primary Contact:
Clinical Trials Office - Memorial Hospital of South Bend
Phone: 800-284-7370 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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