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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00956813 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hot Flashes Menopausal Symptoms Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: flaxseed Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes |
| Estimated Enrollment: | 210 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral flaxseed in the form of a bar similar to a granola bar once daily.
|
Dietary Supplement: flaxseed
Given orally
|
|
Placebo Comparator: Arm II
Patients receive oral placebo bar once daily.
|
Other: placebo
Given orally
|
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Bothersome hot flashes, defined by their occurrence ≥ 28 times per week and of sufficient severity to make the patient desire therapeutic intervention
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Postmenopausal as defined by 1 of the following*:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents
At least 4 weeks since prior and no concurrent anti-cancer therapies of any kind
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)
No concurrent anticoagulants or anti-platelets (1 mg of coumadin for central line patency allowed)
Contacts and Locations
Show 107 Study Locations| Study Chair: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
More Information
| Responsible Party: | Jan C. Buckner, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT00956813 History of Changes |
| Other Study ID Numbers: | CDR0000644811, NCCTG-N08C7 |
| Study First Received: | August 8, 2009 |
| Last Updated: | November 23, 2010 |
| Health Authority: | United States: Federal Government |
|
menopausal symptoms hot flashes breast cancer unspecified adult solid tumor, protocol specific |
|
Breast Neoplasms Hot Flashes Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Signs and Symptoms |