SWOG clinical trial number
S0927
Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain in Women with Early Stage Breast Cancer, Phase III
Closed
Phase
Accrual
100%
Published
Abbreviated Title
Ph III Omega-3 fatty acid/placebo Breast Cancer
Activated
02/01/2012
Closed
02/01/2013
Participants
Research committees
Symptom Control and Quality of Life
Breast Cancer
Treatment
Omega-3-fatty acid
Eligibility Criteria Expand/Collapse
Women with primary invasive adenocarcinoma of the breast (Stage I, II, or III), no evidence of metastatic disease; must have undergone modified radical mastectomy or breast sparing surgery and recovered from all surgery related side effects; post-menopausal (>/= 12 months since last menstrual period, prior bilateral oophorectomy or previous hysterectomy with one of both ovaries left in place and FSH values consistent with institutional norm for post menopausal state; positive for estrogen receptor and/or progesterone receptor; currently taking third generation aromatase inhibitor >/=90 days prior to reg with plans to continue >/= 180 days after reg; complete S0927 Brief Pain Inventory-Short Form and have worst pain/stiffness of >/=5 of the Brief Pain Inventory (item #2); Zubrod PS 0-2; no omega-3-fatty acid supplements within past 3 months; must submit blood for translational medicine and be offered participation in banking; must be able to complete questionnaires in English; not have participated in a clinical trial with an investigational agent within 28 days of reg; not be on anticoagulation medication within 28 days of reg; not have history of bone fracture or surgery of afflicted knees and/or hands within 6 months; not on narcotics within 14 days of reg; no oral or intramuscular corticosteroids or intra-articular steroids to joint within 28 days of reg; not have received topical analgesics to study joint or any other analgesics except nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 14 days of reg; no known allergy to soy; no prior malignancy except adequately treated basal/squamous cell skin cancer, in situ cervical cancer, DCIS, adequately treated Stage I or II cancer from which pt is in CR or other cancer from which pt has been disease-free for 5 yrs.
Publication Information Expand/Collapse
2022
Socioeconomic Deprivation and Patient-Reported Outcomes in Symptom Management Trials for Breast Cancer Patients
2021
PMid: PMID34901744 | PMC number: PMC8660068
2018
PMid: PMID30159789 | PMC number: PMC6681817
2015
PMid: PMID25940724 | PMC number: PMC4451174
2011
SWOG S0927: A randomized doubled blind placebo-controlled trial of omega-3-fatty acid for the control of aromatase inhibitor (AI)-induced musculoskeletal pain in women with early stage breast cancer
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