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 is ongoing, but not recruiting participants.
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01385137
First received: June 28, 2011
Last updated: March 8, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Omega-3 Fatty Acids
U.S. FDA Resources
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 ]
| Estimated Enrollment: | 246 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | March 2014 |
| Estimated 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
|
Show Detailed Description 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385137
Show 292 Study Locations
Show 292 Study LocationsSponsors 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: | CDR0000686712, S0927, U10CA037429 |
| Study First Received: | June 28, 2011 |
| Last Updated: | March 8, 2013 |
| 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 Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013