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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385137

  Show 292 Study Locations
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 21, 2014