You are viewing an expired study

This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please browse nearby listings below.

Click here to view additional nearby studies or search for clinical trials.

Wichita, Kansas 67214

  • Fatigue

Purpose:

This randomized pilot clinical trial studies omega-3 fatty acid in reducing cancer-related fatigue in breast cancer survivors. Supplementation with omega-3 fatty acid may help reduce cancer-related fatigue in breast cancer survivors.


Study summary:

PRIMARY OBJECTIVES: I. To collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation (omega-3 fatty acid) regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing cancer-related fatigue (CRF) in fatigued breast cancer survivors. SECONDARY OBJECTIVES: I. To determine the adherence and adverse events for the two omega-3 supplementation regimens (1.65 g/day and 3.3 g/day) compared to placebo. II. To collect preliminary statistical data (mean changes and standard deviations) on two omega-3 supplementation regimens (1.65 g/day and 3.3 g/day) compared to placebo for reducing inflammation (C-reactive protein [CRP], interleukin 6 [IL-6], and tumor necrosis factor [TNF]-alpha) in fatigued breast cancer survivors. TERTIARY OBJECTIVES: I. To explore the effects of the two omega-3 supplement regimens on serum fatty acid levels compared to placebo. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients receive low-dose omega-3 fatty acid supplementation orally (PO) twice daily (BID) and placebo PO BID for 6 weeks. ARM II: Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. ARM III: Patients receive placebo PO BID for 6 weeks.


Criteria:

Inclusion Criteria: - Have a confirmed diagnosis of breast cancer; participants can have had more than one primary cancer diagnosis in the past - Have undergone some type or combination of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer - Have completed all forms of standard adjuvant treatment (surgery, chemotherapy, radiation therapy) for breast cancer between 4 and 36 months prior to enrollment in the study; participants can be currently taking hormones (such as tamoxifen) or monoclonal antibodies (such as Herceptin) - Must have cancer-related fatigue, as indicated by a response of 4 or greater when asked to rate their level of fatigue at its worst in the past week on an 11-point scale anchored by "0" = no fatigue and "10" = as bad as you can imagine - Be able to read English - Able to swallow medication - Give written informed consent Exclusion Criteria: - Have used marine omega-3 supplements at any time within previous 3 months (this includes prescription omega-3 drugs such as Lovaza®) - Be taking anticoagulant medication (does not include aspirin) - Have sensitivity or allergy to fish and/or shellfish - Have sensitivity or allergy to soy and/or soybeans - Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue


Study is Available At:


Original ID:

URCC13091


NCT ID:

NCT02352779


Secondary ID:

NCI-2014-01191


Study Acronym:


Brief Title:

Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors


Official Title:

Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Rochester


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

108


Enrollment Type:

Actual


Overall Contact Information

Official Name:Luke Peppone
Principal Investigator
University of Rochester NCORP Research Base

Study Dates

Start Date:February 2015
Completion Date:April 2016
Completion Type:Actual
Primary Completion Date:February 2016
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:January 3, 2017
First Received Date:January 28, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Mean change and standard deviation in inflammation, measured by inflammatory marker (CRP, IL-6, TNF-alpha).
Time Frame:Baseline up to 6 weeks
Safety Issues:False
Description:ANCOVA models will be used with baseline as the covariate and follow-up as the response to assess the mean changes and standard deviations from baseline to follow-up between the groups. Separate ANCOVA models will be used for each inflammatory marker (CRP
Outcome Type:Secondary Outcome
Measure:Incidence of adverse events reported using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame:Up to 6 weeks
Safety Issues:True
Description:Chi-square statistic will be calculated to test the difference in adverse events between each omega-3 fatty acid arm versus placebo.
Outcome Type:Secondary Outcome
Measure:Adherence for the two omega-3 fatty acid supplementation regimens compared to placebo, measured by the Morisky Medication Adherence Questionnaire
Time Frame:Up to 6 weeks
Safety Issues:False
Description:A chi-square will be used to test the difference in adherence between each omega-3 fatty acid arm versus placebo. The Morisky Medication Adherence Questionnaire will be administered and used to categorize participants into three groups: high, moderate, an
Outcome Type:Primary Outcome
Measure:Mean change and standard deviation in cancer-related fatigue (CRF) , assessed using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFI-SF)
Time Frame:Baseline to 6 weeks
Safety Issues:False
Description:Analysis of covariance (ANCOVA) models will be used with baseline as the covariate and follow-up as the response to assess the mean changes and standard deviations between the groups. Separate ANCOVA models will be used for the BFI-SF and MFI-SF. The Spea

Study Interventions

Intervention Type:Dietary Supplement
Name:Omega-3 Fatty Acid
Description:Given PO
Arm Name:Arm I (low-dose omega-3 fatty acid)
Other Name:O3FA
Intervention Type:Other
Name:Placebo
Description:Given PO
Arm Name:Arm I (low-dose omega-3 fatty acid)
Other Name:PLCB
Intervention Type:Other
Name:Questionnaire Administration
Description:Ancillary studies
Arm Name:Arm I (low-dose omega-3 fatty acid)
Intervention Type:Other
Name:Laboratory Biomarker Analysis
Description:Correlative studies
Arm Name:Arm I (low-dose omega-3 fatty acid)

Study Arms

Study Arm Type:Experimental
Arm Name:Arm I (low-dose omega-3 fatty acid)
Description:Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks.
Study Arm Type:Experimental
Arm Name:Arm II (high-dose omega-3 fatty acid)
Description:Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.
Study Arm Type:Placebo Comparator
Arm Name:Arm III (placebo)
Description:Patients receive placebo PO BID for 6 weeks.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Gary Morrow
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.