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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
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


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.

Inclusion Criteria


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Hot flash score at week 7

Safety Issue:

No

Principal Investigator

Debra Barton, RN, PhD, AOCN, FAAN

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000644811

NCT ID:

NCT00956813

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

Name

Location

Hurley Medical Center Flint, Michigan  48503
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Aurora Presbyterian Hospital Aurora, Colorado  80012
Boulder Community Hospital Boulder, Colorado  80301-9019
Penrose Cancer Center at Penrose Hospital Colorado Springs, Colorado  80933
CCOP - Colorado Cancer Research Program Denver, Colorado  80224-2522
Porter Adventist Hospital Denver, Colorado  80210
Presbyterian - St. Luke's Medical Center Denver, Colorado  80218
St. Joseph Hospital Denver, Colorado  80218
Rose Medical Center Denver, Colorado  80220
Swedish Medical Center Englewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center Grand Junction, Colorado  81502
Sky Ridge Medical Center Lone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United Hospital Longmont, Colorado  80502
St. Mary - Corwin Regional Medical Center Pueblo, Colorado  81004
North Suburban Medical Center Thornton, Colorado  80229
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
MeritCare Bemidji Bemidji, Minnesota  56601
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Rapid City Regional Hospital Rapid City, South Dakota  57709
Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Dayton Kettering, Ohio  45429
Hinsdale, Illinois  60521
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
CCOP - Grand Rapids Grand Rapids, Michigan  49503
CCOP - Columbia River Oncology Program Portland, Oregon  97225
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
McCreery Cancer Center at Ottumwa Regional Ottumwa, Iowa  52501
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
North Colorado Medical Center Greeley, Colorado  80631
McKee Medical Center Loveland, Colorado  80539
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Munson Medical Center Traverse City, Michigan  49684
Butterworth Hospital at Spectrum Health Grand Rapids, Michigan  49503-2560
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown, Pennsylvania  18105
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Bettendorf, Iowa  52722
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des Moines West Des Moines, Iowa  50266
Mecosta County Medical Center Big Rapids, Michigan  49307
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Holy Family Memorial Medical Center Cancer Care Center Manitowoc, Wisconsin  54221-1450
St. Anthony Central Hospital Denver, Colorado  80204-1335
Exempla Lutheran Medical Center Wheat Ridge, Colorado  80033
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Reid Hospital & Health Care Services Richmond, Indiana  47374
Drs. Carrol, Sheth, Raghavan Louisville, Kentucky  40215
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Fergus Falls Medical Group, PA Fergus Falls, Minnesota  56537
Wayne Hospital Greenville, Ohio  45331
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Mercy General Health Partners Muskegon, Michigan  49443
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Immanuel St. Joseph's Mankato, Minnesota  56002