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Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes

Phase 3
18 Years
Open (Enrolling)
Breast Cancer, Hot Flashes, Menopausal Symptoms, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes


- 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

- 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.

Inclusion Criteria


- 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


- 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


- 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)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Hot flash score at week 7

Safety Issue:


Principal Investigator

Debra Barton, RN, PhD, AOCN, FAAN

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

October 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • Menopausal Symptoms
  • Unspecified Adult Solid Tumor, Protocol Specific
  • menopausal symptoms
  • hot flashes
  • breast cancer
  • unspecified adult solid tumor, protocol specific
  • Breast Neoplasms
  • Hot Flashes



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