S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
Arthralgia, Breast Cancer, Pain
About this trial
This is an interventional supportive care trial for Arthralgia focused on measuring estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, pain, arthralgia
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive adenocarcinoma of the breast
- Stage I, II, or IIIA disease
- No metastatic disease
- Must have undergone modified radical mastectomy or breast-sparing surgery and recovered
- Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)
- Currently taking a third-generation aromatase inhibitor (AI) [e.g., anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)] for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration
- Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14 days, and must have a worst pain/stiffness of ≥ 5 on the BPI (item #2) that has started or increased with AI therapy
PATIENT CHARACTERISTICS:
- Postmenopausal
- Zubrod performance status 0-2
- Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory markers (IL6, TNF-α, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and DNA analysis (CYP19A1)
- Able to complete study questionnaires in English
- At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission
- Patients must not have a known allergy to soy, given that the placebo is suspended in soybean oil
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain from omega-3-fatty acid supplements from sources outside of this study
- More than 28 days since prior investigational agents
- No other medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days
- Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of increased risk of bleeding within 28 days prior to registration
- Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration
- Patients must not be on narcotics within 14 days of registration
Patients may have received corticosteroid treatment; however, the following criteria apply:
- Patients must not have received oral or intramuscular corticosteroids within the 28 days prior to registration
- Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration
- Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with the exception of nonsteroidal antiinflammatory drugs (NSAIDs) and acetaminophen) within 14 days prior to registration
Sites / Locations
- Providence Cancer Center at Providence Hospital
- Alaska Regional Hospital Cancer Center
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Highlands Oncology Group - Springdale
- Kaiser Permanente Medical Center - Anaheim/Orange County
- Kaiser Permanente - Deer Valley
- Kaiser Permanente Medical Center - Baldwin Park
- Kaiser Permanente Medical Center - Bellflower
- Alta Bates Summit Comprehensive Cancer Center
- Peninsula Medical Center
- Kaiser Permanente Medical Center - Fontana
- Kaiser Permanente - Fremont
- Kaiser Permanente Fresno Medical Center
- Kaiser Permanente Medical Center - Harbor City
- Kaiser Permanente Medical Center - Hayward
- Kaiser Permanente - Irvine
- Kaiser Permanente Medical Center - Los Angeles
- Kaiser Foundation Hospital - West Los Angeles
- USC/Norris Comprehensive Cancer Center and Hospital
- Contra Costa Regional Medical Center
- Tibotec Therapeutics - Division of Ortho Biotech Products, LP
- Mercy Cancer Center at Mercy Medical Center
- El Camino Hospital Cancer Center
- Sutter Health - Western Division Cancer Research Group
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- CCOP - Bay Area Tumor Institute
- Kaiser Permanente Medical Center - Oakland
- Epic Care - Oakland
- Kaiser Permanente Medical Group
- Valley Medical Oncology Consultants - Pleasanton
- Kaiser Permanente Medical Center - Redwood City
- Kaiser Permanente Medical Center - Richmond
- Kaiser Permanente Medical Center - Riverside
- Kaiser Permanente Medical Center - Roseville
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- University of California Davis Cancer Center
- South Sacramento Kaiser-Permanente Medical Center
- Kaiser Permanente Medical Center - Sacramento
- Kaiser Permanente Medical Office -Vandever Medical Office
- Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- California Pacific Medical Center - California Campus
- Kaiser Permanente Medical Center - Santa Teresa
- Kaiser Permanente Health Care
- Doctors Medical Center - San Pablo Campus
- Kaiser Foundation Hospital - San Rafael
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
- Kaiser Permanente Medical Center - Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente Medical Center - South San Francisco
- Kaiser Permanente Medical Facility - Stockton
- Tahoe Forest Cancer Center
- Kaiser Permanente Medical Center - Vacaville
- Kaiser Permanente Medical Center - Vallejo
- Sutter Solano Medical Center
- Kaiser Permanente Medical Center - Walnut Creek
- Kaiser Permanente Medical Cener - Woodland Hills
- Kaiser Permanente - Denver
- Poudre Valley Hospital
- Front Range Cancer Specialists
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Broward General Medical Center Cancer Center
- Northeast Georgia Medical Center
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Kaiser Permanente - Moanalua Medical Center and Clinic
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Saint Luke's Mountain States Tumor Institute - Fruitland
- St. Joseph Regional Medical Center
- Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute
- Mountain States Tumor Institute at St. Luke's
- Decatur Memorial Hospital Cancer Care Institute
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital Cancer Center
- Regional Cancer Center at Memorial Medical Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Reid Hospital & Health Care Services
- Genesis Regional Cancer Center at Genesis Medical Center
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas, PA - Liberal
- Cancer Center of Kansas, PA - Newton
- Menorah Medical Center
- Saint Luke's Hospital - South
- Cancer Center of Kansas, PA - Parsons
- CCOP - Kansas City
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cotton-O'Neil Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Central Baptist Hospital
- CHRISTUS Cabrini Cancer Center
- Louisiana State University Health Sciences Center - Monroe
- Highland Clinic
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Lahey Clinic Medical Center - Burlington
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- University of Michigan Comprehensive Cancer Center
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Josephine Ford Cancer Center at Henry Ford Hospital
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- McLaren Cancer Institute
- Singh and Arora Hematology Oncology, PC
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Memorial Hospital
- Sparrow Regional Cancer Center
- Great Lakes Cancer Institute - Lapeer Campus
- St. Mary Mercy Hospital
- Clemens Regional Medical Center
- Mercy General Health Partners
- Northern Michigan Hospital
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- Spectrum Health Reed City Hospital
- Seton Cancer Institute at Saint Mary's - Saginaw
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- University of Mississippi Cancer Clinic
- Regional Cancer Center at Singing River Hospital
- Central Care Cancer Center at Carrie J. Babb Cancer Center
- Saint Francis Medical Center
- Saint Luke's Cancer Institute at Saint Luke's Hospital
- North Kansas City Hospital
- Heartland Hematology Oncology Associates, Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Parvin Radiation Oncology
- Phelps County Regional Medical Center
- Heartland Regional Medical Center
- Midwest Hematology Oncology Group, Incorporated
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- St. Vincent Healthcare Cancer Care Services
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- Sletten Cancer Institute at Benefis Healthcare
- St. Peter's Hospital
- Kalispell Regional Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Lovelace Medical Center - Downtown
- University of New Mexico Cancer Center
- Falck Cancer Center at Arnot Ogden Medical Center
- Tucker Center for Cancer Care at Orange Regional Medical Center
- Winthrop University Hospital
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- Highland Hospital of Rochester
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Randolph Hospital
- Mission Hospitals - Memorial Campus
- Presbyterian Cancer Center at Presbyterian Hospital
- CaroMont Cancer Center at Gaston Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Pardee Memorial Hospital
- Iredell Memorial Hospital
- McDowell Cancer Center at Akron General Medical Center
- Adena Regional Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Knox Community Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- Southern Ohio Medical Center Cancer Center
- Community Hospital of Springfield and Clark County
- UVMC Cancer Care Center at Upper Valley Medical Center
- Mount Carmel St. Ann's Cancer Center
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- St. Charles Medical Center - Bend
- Clackamas Radiation Oncology Center
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Providence Newberg Medical Center
- Willamette Falls Hospital
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Salem Hospital Regional Cancer Care Services
- Legacy Meridian Park Hospital
- AnMed Cancer Center
- McLeod Regional Medical Center
- Bon Secours St. Francis Health System
- Cancer Centers of the Carolinas - Faris Road
- Cancer Centers of the Carolinas - Grove Commons
- CCOP - Greenville
- Self Regional Cancer Center at Self Regional Medical Center
- Cancer Centers of the Carolinas - Greer Medical Oncology
- Carolina Blood and Cancer Care Associates, PA
- Carolina Blood and Cancer Care
- Cancer Centers of the Carolinas - Seneca
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Cancer Centers of the Carolinas - Spartanburg
- Thompson Cancer Survival Center
- Baylor University Medical Center - Dallas
- Methodist Hospital
- Baylor Medical Center at Irving
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- Huntsman Cancer Institute at University of Utah
- LDS Hospital
- Danville Regional Medical Center
- Island Hospital Cancer Care Center at Island Hospital
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Highline Medical Center Cancer Center
- Providence Centralia Hospital
- Providence Regional Cancer Partnership
- St. Francis Hospital
- Swedish Medical Center - Issaquah Campus
- Columbia Basin Hematology
- Cascade Cancer Center at Evergreen Hospital Medical Center
- Skagit Valley Hospital Cancer Care Center
- Providence St. Peter Hospital Regional Cancer Center
- Harrison Poulsbo Hematology and Onocology
- Good Samaritan Cancer Center
- CCOP - Virginia Mason Research Center
- Harborview Medical Center
- Minor and James Medical, PLLC
- Pacific Medical Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Polyclinic First Hill
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Evergreen Hematology and Oncology, PS
- Franciscan Cancer Center at St. Joseph Medical Center
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- Legacy Salmon Creek Medical Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Rocky Mountain Oncology
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I
Arm II
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.