Trial record 1 of 4 for:    S0927
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S0927: Omega-3-Fatty Acid Supplements in Treating Muscle and Bone Pain and Stiffness in Pts W/Stage I, II, or III Breast Cancer Receiving Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01385137
First received: June 28, 2011
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and bone pain and stiffness caused by hormone therapy in patients with breast cancer.

PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III breast cancer receiving hormone therapy.


Condition Intervention Phase
Arthralgia
Breast Cancer
Pain
Dietary Supplement: omega-3 fatty acid
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: S0927: A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Reduction in worst joint pain and/or stiffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of joint pain and stiffness improvement versus deterioration with omega-3-fatty acid versus placebo [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTCAE vs 4.0 [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of new pain medications used [ Time Frame: 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
  • Changes in serum-free and total estradiol levels as measured by liquid chromatography and mass spectrometry [ Time Frame: 2 years from study activation ] [ Designated as safety issue: No ]
  • Changes in hormonal and inflammatory serum biomarkers [ Time Frame: 2 years from study activation ] [ Designated as safety issue: No ]
  • Changes in fasting cholesterol levels [ Time Frame: 2 years from study activation ] [ Designated as safety issue: No ]

Enrollment: 262
Study Start Date: February 2012
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
Dietary Supplement: omega-3 fatty acid
Given orally
Placebo Comparator: Arm II
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.
Other: placebo
Given orally

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01385137

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Locations
United States, Alabama
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
United States, Alaska
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Highlands Oncology Group - Springdale
Rogers, Arkansas, United States, 72758
United States, California
Kaiser Permanente Medical Center - Anaheim/Orange County
Anaheim, California, United States, 92807
Kaiser Permanente - Deer Valley
Antioch, California, United States, 94531
Kaiser Permanente Medical Center - Baldwin Park
Baldwin Park, California, United States, 91706
Kaiser Permanente Medical Center - Bellflower
Bellflower, California, United States, 90706
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Peninsula Medical Center
Burlingame, California, United States, 94010
Kaiser Permanente Medical Center - Fontana
Fontana, California, United States, 92335
Kaiser Permanente - Fremont
Fremont, California, United States, 94538
Kaiser Permanente Fresno Medical Center
Fresno, California, United States, 93720
Kaiser Permanente Medical Center - Harbor City
Harbor City, California, United States, 90710
Kaiser Permanente Medical Center - Hayward
Hayward, California, United States, 94545
Kaiser Permanente - Irvine
Irvine, California, United States, 92618
Kaiser Foundation Hospital - West Los Angeles
Los Angeles, California, United States, 90034
Kaiser Permanente Medical Center - Los Angeles
Los Angeles, California, United States, 90027
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States, 95901
Mercy Cancer Center at Mercy Medical Center
Merced, California, United States, 95340
El Camino Hospital Cancer Center
Mountain View, California, United States, 94040
Sutter Health - Western Division Cancer Research Group
Novato, California, United States, 94945
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609
Highland General Hospital
Oakland, California, United States, 94602
Epic Care - Oakland
Oakland, California, United States, 94612
Kaiser Permanente Medical Center - Oakland
Oakland, California, United States, 94611
Kaiser Permanente Medical Group
Panorama City, California, United States, 91402
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States, 94588
Kaiser Permanente Medical Center - Redwood City
Redwood City, California, United States, 94063
Kaiser Permanente Medical Center - Richmond
Richmond, California, United States, 94801
Kaiser Permanente Medical Center - Riverside
Riverside, California, United States, 92505
Kaiser Permanente Medical Center - Roseville
Roseville, California, United States, 95661
Sutter Cancer Center at Roseville Medical Center
Roseville, California, United States, 95661
University of California Davis Cancer Center
Sacramento, California, United States, 95817
South Sacramento Kaiser-Permanente Medical Center
Sacramento, California, United States, 95823
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Sutter Cancer Center
Sacramento, California, United States, 95816
Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92108
California Pacific Medical Center - California Campus
San Francisco, California, United States, 94118
Kaiser Permanente Medical Center - San Francisco Geary Campus
San Francisco, California, United States, 94115
Kaiser Permanente Medical Center - Santa Teresa
San Jose, California, United States, 95119
Kaiser Permanente Health Care
San Marcos, California, United States, 92078
Doctors Medical Center - San Pablo Campus
San Pablo, California, United States, 94806
Kaiser Foundation Hospital - San Rafael
San Rafael, California, United States, 94903
Kaiser Permanente Medical Center - Santa Clara Kiely Campus
Santa Clara, California, United States, 95051
Kaiser Permanente Medical Center - Santa Rosa
Santa Rosa, California, United States, 95403
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - South San Francisco
South San Francisco, California, United States, 94080
Kaiser Permanente Medical Facility - Stockton
Stockton, California, United States, 95210
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
Kaiser Permanente Medical Center - Vacaville
Vacaville, California, United States, 95688
Sutter Solano Medical Center
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
Kaiser Permanente Medical Center - Walnut Creek
Walnut Creek, California, United States, 94596
Kaiser Permanente Medical Cener - Woodland Hills
Woodland Hills, California, United States, 91367
United States, Colorado
Kaiser Permanente - Denver
Denver, Colorado, United States, 80205
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Florida
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States, 33316
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
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Kaiser Permanente - Moanalua Medical Center and Clinic
Honolulu, Hawaii, United States, 96819
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho, United States, 83619
St. Joseph Regional Medical Center
Lewiston, Idaho, United States, 83501
Mountain States Tumor Institute - Meridian
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute
Nampa, Idaho, United States, 83686
Mountain States Tumor Institute at St. Luke's
Twin Falls, Idaho, United States, 83301
United States, Illinois
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States, 62864
Edward Hospital Cancer Center
Naperville, Illinois, United States, 60540
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
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St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
United States, Iowa
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Saint Luke's Hospital - South
Overland Park, Kansas, United States, 66213
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
CCOP - Kansas City
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Louisiana
CHRISTUS Cabrini Cancer Center
Alexandria, Louisiana, United States, 71301
Louisiana State University Health Sciences Center - Monroe
Monroe, Louisiana, United States, 71210
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
Highland Clinic
Shreveport, Louisiana, United States, 71105
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, United States, 01805
United States, Michigan
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
McLaren Cancer Institute
Flint, Michigan, United States, 48532
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Singh and Arora Hematology Oncology, PC
Flint, Michigan, United States, 48532
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
Great Lakes Cancer Institute - Lapeer Campus
Lapeer, Michigan, United States, 48446
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Clemens Regional Medical Center
Mount Clemens, Michigan, United States, 48043
Mercy General Health Partners
Muskegon, Michigan, United States, 49444
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Central Care Cancer Center at Carrie J. Babb Cancer Center
Bolivar, Missouri, United States, 65613
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Heartland Hematology Oncology Associates, Incorporated
Kansas City, Missouri, United States, 64118
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Parvin Radiation Oncology
Liberty, Missouri, United States, 64068
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Midwest Hematology Oncology Group, Incorporated
Saint Louis, Missouri, United States, 63109
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
United States, New Mexico
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
United States, New York
Falck Cancer Center at Arnot Ogden Medical Center
Elmira, New York, United States, 14905
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States, 10940-4199
Winthrop University Hospital
Mineola, New York, United States, 11501
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Highland Hospital of Rochester
Rochester, New York, United States, 14620
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203-5400
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
CaroMont Cancer Center at Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28053
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198
Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
CCOP - Columbus
Columbus, Ohio, United States, 43215
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
CCOP - Dayton
Dayton, Ohio, United States, 45420
Grandview Hospital
Dayton, Ohio, United States, 45405
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, United States, 45662
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oregon
St. Charles Medical Center - Bend
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Willamette Falls Hospital
Oregon City, Oregon, United States, 97045
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Salem Hospital Regional Cancer Care Services
Salem, Oregon, United States, 97309-5014
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States, 29605
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Bon Secours St. Francis Health System
Greenville, South Carolina, United States, 29601
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Self Regional Cancer Center at Self Regional Medical Center
Greenwood, South Carolina, United States, 29646
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, United States, 29650
Carolina Blood and Cancer Care Associates, PA
Lancaster, South Carolina, United States, 29720
Carolina Blood and Cancer Care
Rock Hill, South Carolina, United States, 29732
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Baylor University Medical Center - Dallas
Dallas, Texas, United States, 75246
Methodist Hospital
Houston, Texas, United States, 77030
Baylor Medical Center at Irving
Irving, Texas, United States, 75061
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
United States, Washington
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center Cancer Center
Burien, Washington, United States, 98166
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
St. Francis Hospital
Federal Way, Washington, United States, 98003
Swedish Medical Center - Issaquah Campus
Issaquah, Washington, United States, 98029
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Cascade Cancer Center at Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98033
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States, 98274
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, United States, 98370
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Group Health Central Hospital
Seattle, Washington, United States, 98112
Harborview Medical Center
Seattle, Washington, United States, 98104
Polyclinic First Hill
Seattle, Washington, United States, 98122
Pacific Medical Center
Seattle, Washington, United States, 98104
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States, 98284
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology, PS
Spokane, Washington, United States, 99218
CCOP - Northwest
Tacoma, Washington, United States, 98405
Allenmore Hospital
Tacoma, Washington, United States, 98405
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
St. Clare Hospital
Tacoma, Washington, United States, 98499
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
Legacy Salmon Creek Medical Center
Vancouver, Washington, United States, 98686
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98664
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801-2028
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
Principal Investigator: Laurence H. Baker, DO, FACOI University of Michigan Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01385137     History of Changes
Other Study ID Numbers: S0927, S0927, U10CA037429
Study First Received: June 28, 2011
Last Updated: April 22, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
pain
arthralgia

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Breast Diseases
Joint Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Pain
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014