Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes
Study ID: NCT00956813
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
St. Anthony Central Hospital, Denver, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center, Grand Junction, Colorado, United States
North Colorado Medical Center, Greeley, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
McKee Medical Center, Loveland, Colorado, United States
St. Mary - Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thornton, Colorado, United States
Exempla Lutheran Medical Center, Wheat Ridge, Colorado, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus, Moline, Illinois, United States
, Moline, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus, Beech Grove, Indiana, United States
Elkhart Clinic, LLC, Elkhart, Indiana, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
Saint Joseph Regional Medical Center, Mishawaka, Indiana, United States
Reid Hospital & Health Care Services, Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend, South Bend, Indiana, United States
South Bend Clinic, South Bend, Indiana, United States
, Bettendorf, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, Clive, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Drs. Carrol, Sheth, Raghavan, Louisville, Kentucky, United States
Saint Joseph Mercy Cancer Center, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center, Battle Creek, Michigan, United States
Mecosta County Medical Center, Big Rapids, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Butterworth Hospital at Spectrum Health, Grand Rapids, Michigan, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center, Grosse Pointe Woods, Michigan, United States
Dickinson County Healthcare System, Iron Mountain, Michigan, United States
Foote Memorial Hospital, Jackson, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
St. Mary Mercy Hospital, Livonia, Michigan, United States
Mercy General Health Partners, Muskegon, Michigan, United States
St. Joseph Mercy Oakland, Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital, Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw, Saginaw, Michigan, United States
Lakeside Cancer Specialists, PLLC, Saint Joseph, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
St. John Macomb Hospital, Warren, Michigan, United States
Metro Health Hospital, Wyoming, Michigan, United States
MeritCare Bemidji, Bemidji, Minnesota, United States
Fergus Falls Medical Group, PA, Fergus Falls, Minnesota, United States
Immanuel St. Joseph's, Mankato, Minnesota, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Broadway, Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital, Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital, Dayton, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital, Kettering, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center, Troy, Ohio, United States
Clinton Memorial Hospital, Wilmington, Ohio, United States
United States Air Force Medical Center - Wright-Patterson, Wright-Patterson Afb, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital, Xenia, Ohio, United States
Providence Milwaukie Hospital, Milwaukie, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center, Portland, Oregon, United States
Adventist Medical Center, Portland, Oregon, United States
CCOP - Columbia River Oncology Program, Portland, Oregon, United States
Providence St. Vincent Medical Center, Portland, Oregon, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota, United States
Southwest Washington Medical Center Cancer Center, Vancouver, Washington, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Holy Family Memorial Medical Center Cancer Care Center, Manitowoc, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Debra Barton, RN, PhD, AOCN, FAAN
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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