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Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

Primary Purpose

Arthralgia, Breast Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omega-3 Fatty Acid
Placebo
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthralgia focused on measuring Breast Cancer, Postmenopausal, Stage IA, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB, Stage IIIC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole)
  • Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed.
  • Prior tamoxifen use is allowed
  • Prior chemotherapy is allowed
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Metastatic malignancy of any kind
  • Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
  • AI use > 21 days prior to study enrollment
  • Known bleeding disorders
  • Current use of warfarin or other anticoagulants
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
  • Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation
  • Pregnant or nursing women
  • Known sensitivity or allergy to fish or fish oil
  • Unable to give informed consent

Sites / Locations

  • City of Hope
  • Cleveland Clinic Cancer Center/Fairview Hospital
  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm I (omega-3 fatty acid)

Arm II (placebo)

Arm Description

Patients receive omega-3 fatty acid supplementation PO QD for 6 months.

Patients receive placebo PO QD for 6 months.

Outcomes

Primary Outcome Measures

Change in pain score based on the Brief Pain Inventory (BPI)
Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.

Secondary Outcome Measures

Change in joint symptoms based on quality of life instruments
An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups.
Change in joint symptoms based on symptomatology instruments
An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups.
Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias
Interaction tests between treatment and stratification variables will be conducted to explore whether these factors are predictive of average pain scores.
Rate of compliance
The rates of adherence to and discontinuation of AI therapy will be recorded. Reasons for treatment discontinuation will be described. In addition, the investigators will also examine the compliance rates with n-3 PUFA or placebo supplements with pill counts at each visit and with a patient recorded medication calendar.
SNP analysis by standard data preprocessing operations and sequential analysis
A sequential analysis of the data that allows filtering of extraneous SNPs and select SNP loci, identification and creation of predictive SNP clusters, and then evaluation of the networks' potential clinical and biological validity will be performed.

Full Information

First Posted
May 1, 2016
Last Updated
February 24, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02831582
Brief Title
Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
Official Title
Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 12, 2016 (Actual)
Primary Completion Date
December 11, 2021 (Actual)
Study Completion Date
December 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial studies the use of omega-3 fatty acid supplementation in preventing aromatase inhibitor-induced toxicity in patients with stage I-III breast cancer. An omega-3 supplementation may help relieve moderate to severe bone pain and improve joint symptoms caused by aromatase inhibitor-induced arthralgias.
Detailed Description
PRIMARY OBJECTIVES: I. To determine the efficacy of the complementary therapy omega-3 fatty acid (n-3 PUFA) supplementation in preventing aromatase inhibitor-induced arthralgias (AIIAs). SECONDARY OBJECTIVES: I. To prospectively define the population most at risk for developing AIIAs by the identification and validation of genetic risk predictors and to develop a single nucleotide polymorphism (SNP)/gene profile predictive of treatment intervention response. OUTLINE: Patients are randomized to 1 of 2 groups. Group I: Patients receive omega-3 fatty acid supplementation orally (PO) once daily (QD) for 6 months. Group II: Patients receive placebo PO QD for 6 months. After completion of study, patients will be followed up periodically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthralgia, Breast Neoplasms
Keywords
Breast Cancer, Postmenopausal, Stage IA, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB, Stage IIIC

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (omega-3 fatty acid)
Arm Type
Active Comparator
Arm Description
Patients receive omega-3 fatty acid supplementation PO QD for 6 months.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO QD for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 Fatty Acid
Other Intervention Name(s)
n-3 Fatty Acid, Omega 3 Fatty Acid, OMEGA-3 FATTY ACIDS, Omega-3 Polyunsaturated Fatty Acid, Omega-3 PUFA, omega-3-Fatty Acids
Intervention Description
Given PO.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, sham therapy
Intervention Description
Given PO.
Primary Outcome Measure Information:
Title
Change in pain score based on the Brief Pain Inventory (BPI)
Description
Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.
Time Frame
Baseline to up to 6 months
Secondary Outcome Measure Information:
Title
Change in joint symptoms based on quality of life instruments
Description
An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups.
Time Frame
Baseline to up to 6 months
Title
Change in joint symptoms based on symptomatology instruments
Description
An exploratory analysis, logistic mixed effect regression models will be used to compare the occurrence of moderate to severe joint symptoms during the 6 month period between the two treatment groups.
Time Frame
Baseline to up to 6 months
Title
Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias
Description
Interaction tests between treatment and stratification variables will be conducted to explore whether these factors are predictive of average pain scores.
Time Frame
Up to 6 months
Title
Rate of compliance
Description
The rates of adherence to and discontinuation of AI therapy will be recorded. Reasons for treatment discontinuation will be described. In addition, the investigators will also examine the compliance rates with n-3 PUFA or placebo supplements with pill counts at each visit and with a patient recorded medication calendar.
Time Frame
Up to 6 months
Title
SNP analysis by standard data preprocessing operations and sequential analysis
Description
A sequential analysis of the data that allows filtering of extraneous SNPs and select SNP loci, identification and creation of predictive SNP clusters, and then evaluation of the networks' potential clinical and biological validity will be performed.
Time Frame
Up to 6 months
Other Pre-specified Outcome Measures:
Title
Level of inflammatory markers
Time Frame
Up to 6 months
Title
Red blood cells (RBC) n-3 PUFA levels
Description
The relationship between RBC n-3 PUFA levels, inflammatory blood markers and the joint symptoms evaluated by the patient symptom assessment instruments. Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pairwise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the FDA-approved AIs (anastrazole, exemestane, letrozole) Concurrent gonadotropin-releasing hormone (GnRH) agonist therapy is allowed; concurrent breast related radiation therapy is allowed. Prior tamoxifen use is allowed Prior chemotherapy is allowed Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Metastatic malignancy of any kind Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease AI use > 21 days prior to study enrollment Known bleeding disorders Current use of warfarin or other anticoagulants Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements Daily use of n-3 PUFA concentrates or capsules or any other supplements that might interact with n-3 PUFA supplements if > 375 mg per day of of eicosapentaenoic acid (EPA)/ docosahexaenoic acid (DHA) within six months of study initiation Pregnant or nursing women Known sensitivity or allergy to fish or fish oil Unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Williams, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Cleveland Clinic Cancer Center/Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35005781
Citation
Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer

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