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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Hot flash score at week 7
No
Debra Barton, RN, PhD, AOCN, FAAN
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000644811
NCT00956813
October 2009
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 |