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

June 28, 2011
April 22, 2014
February 2012
December 2013   (final data collection date for primary outcome measure)
Reduction in worst joint pain and/or stiffness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reduction in worst joint pain and/or stiffness at 12 weeks [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01385137 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Proportion of joint pain and stiffness improvement versus deterioration with omega-3-fatty acid versus placebo [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTCAE vs 4.0 [ Designated as safety issue: Yes ]
  • Frequency of new pain medications used [ Designated as safety issue: No ]
  • Changes in serum-free and total estradiol levels as measured by liquid chromatography and mass spectrometry [ Designated as safety issue: No ]
  • Changes in hormonal and inflammatory serum biomarkers [ Designated as safety issue: No ]
  • Changes in fasting cholesterol levels [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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

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.

OBJECTIVES:

Primary

  • To assess whether omega-3-fatty acid as compared to placebo causes a reduction in worst joint pain and/or stiffness at 12 weeks, as measured by the modified Brief Pain Inventory (BPI), in women with early-stage breast cancer and aromatase inhibitor (AI)-associated arthralgia.

Secondary

  • To assess the proportion of patients who report improved versus deteriorated joint pain with omega-3-fatty acid versus placebo.
  • To assess the proportion of patients who report improved versus deteriorated joint stiffness with omega-3-fatty acid versus placebo.
  • To assess whether patients receiving omega-3-fatty acid compared to placebo have decreased analgesic use and increased AI adherence.
  • To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functioning, pain, and stiffness in the knees/hips (as measured by the Western Ontario and McMaster Universities Osteoarthritis, WOMAC) score.
  • To assess whether patients receiving omega-3-fatty acid have improved functioning, pain, and stiffness in the hands (as measured by the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, M-SACRAH).
  • To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Trial Outcome Index (TOI).
  • To assess whether patients receiving omega-3-fatty acid report changes for the better versus worse compared to placebo as measured by the Global Rating of Change Scale.
  • To identify minimally important change in the WOMAC, M-SACRAH, and the FACT-ES Trial Outcome Index (TOI) using "a little better" or "a little worse" responses on the patient-reported global rating of change in joint pain and joint stiffness.
  • To assess whether patients receiving omega-3-fatty acid compared to placebo have an improved lipid profile as measured by triglycerides, HDL, and LDL.
  • To assess the toxicity of omega-3-fatty acid compared to placebo in this setting.
  • To assess whether there is a difference in serum-free and total estradiol levels before and after treatment with omega-3-fatty acid compared to placebo.
  • To explore whether CYP19A1 genotype correlates with severity of joint symptoms or predicts response to omega-3-fatty acid. (exploratory)
  • To explore changes in hormonal and inflammatory serum biomarkers, such as IL6, TNF-α, and CRP.
  • To assess whether there is a relationship between change in serum docosahexaenoic acid (DHA) and EPA and resolution of joint symptoms.
  • To establish a cohort of patients (placebo group) to better characterize the natural history of the syndrome.

OUTLINE: This is a multicenter study. Patients are stratified according to prior osteoarthritis (yes vs no) and prior taxane use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • 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.
  • Arm II: Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and at 12 and 24 weeks for biomarker and DNA analysis.

Patients complete the Brief Pain Inventory Short Form (BPI-SF), the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the FACT-ES Trial Outcome Index, and the Omega-3-fatty acid Dietary Intake questionnaires at baseline and at 6, 12, and 24 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Arthralgia
  • Breast Cancer
  • Pain
  • Dietary Supplement: omega-3 fatty acid
    Given orally
  • Other: placebo
    Given orally
  • 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.
    Intervention: Dietary Supplement: omega-3 fatty acid
  • Placebo Comparator: Arm II
    Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
262
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01385137
S0927, S0927, U10CA037429
Yes
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Dawn Hershman, MD Herbert Irving Comprehensive Cancer Center
Principal Investigator: Laurence H. Baker, DO, FACOI University of Michigan Cancer Center
Southwest Oncology Group
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP