Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02352779
Other study ID # URCC13091
Secondary ID NCI-2014-01191UR
Status Completed
Phase Phase 2
First received January 28, 2015
Last updated January 3, 2017
Start date February 2015
Est. completion date April 2016

Study information

Verified date January 2017
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date April 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 120 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Omega-3 Fatty Acid
Given PO
Other:
Placebo
Given PO
Questionnaire Administration
Ancillary studies
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Dayton NCORP Dayton Ohio
United States Cancer Research Consortium of West Michigan Grand Rapids Michigan
United States Greenville Health System NCORP Greenville South Carolina
United States Wisconsin NCORP Marshfield Wisconsin
United States University of Rochester NCORP Research Base Rochester New York
United States Wichita NCORP Wichita Kansas

Sponsors (2)

Lead Sponsor Collaborator
Gary Morrow National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in serum fatty acid level The differences between the three arms will be evaluated in time trajectory of the serum fatty acid levels with a linear mixed-effects model. The three time points (weeks 0, 3, and 6) will be the response. Comparisons of least squares means between arms will be performed using the Tukey multiple comparisons procedure. Baseline up to 6 weeks No
Primary 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) 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 Spearman Rank correlation will be calculated between the change in serum omega-3 fatty acid levels and changes in BFI-SF and MFI-SF to examine the dose-response effect. Baseline to 6 weeks No
Secondary Adherence for the two omega-3 fatty acid supplementation regimens compared to placebo, measured by the Morisky Medication Adherence Questionnaire 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, and low adherence. Adherence differences between actual and believed group assignment will be examined. Up to 6 weeks No
Secondary Incidence of adverse events reported using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 Chi-square statistic will be calculated to test the difference in adverse events between each omega-3 fatty acid arm versus placebo. Up to 6 weeks Yes
Secondary Mean change and standard deviation in inflammation, measured by inflammatory marker (CRP, IL-6, TNF-alpha). 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, IL-6, TNF-alpha). Baseline up to 6 weeks No
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients