ArthralgiaNCT02831582
Omega-3 Supplementation in Prevention of Aromatase Inhibitor-Induced Toxicity in Patients With Stage I-III Breast Cancer
A study testing Omega-3 Fatty Acid in people with Arthralgia and Breast Neoplasms, run by Ohio State University Comprehensive Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthralgia, Breast Neoplasms
- What is being tested?
- Omega-3 Fatty Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Oct 2016to 11 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44195
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
About this study
Official title: Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Arthralgia, Breast Neoplasms
- Being tested
- Omega-3 Fatty Acid, Placebo
- Keywords
- Breast Cancer, Postmenopausal, Stage IA, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB, Stage IIIC
- Medical subject headings
- Arthralgia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidDietary supplement
Also called n-3 Fatty Acid, Omega 3 Fatty Acid, OMEGA-3 FATTY ACIDS, Omega-3 Polyunsaturated Fatty Acid
Given PO.
PlaceboOther
Also called placebo therapy, sham therapy
Given PO.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (omega-3 fatty acid) | Active comparator | Patients receive omega-3 fatty acid supplementation PO QD for 6 months. Receives: Dietary Supplement: Omega-3 Fatty Acid |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO QD for 6 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to up to 6 months
Secondary outcomes (5)
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.
Measured: Baseline to up to 6 months
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.
Measured: Baseline to up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start12 Oct 2016
- Primary completion11 Dec 2021
- Study completion11 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArthralgiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Williams, Ohio State University Comprehensive Cancer Center
- Investigators
- Nicole Williams, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831582
- Sponsor's protocol ID
- OSU-15222
- Other IDs
- NCI-2016-00377
- Status last verified
- Feb 2023
- First submitted
- 1 May 2016
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35005781
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Aromatase Inhibitor-Induced Toxicity With Omega-3 Supplementation
- ClinicalTrials.gov ID
- NCT02831582
- Acronym / sponsor ID
- OSU-15222
- Conditions
- Arthralgia, Breast Neoplasms
- Keywords
- Breast Cancer, Postmenopausal, Stage IA, Stage IB, Stage IIA, Stage IIB, Stage IIIA, Stage IIIB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Oct 2016 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 11 Dec 2021 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (omega-3 fatty acid) | Active comparator | Dietary Supplement: Omega-3 Fatty AcidPatients receive omega-3 fatty acid supplementation PO QD for 6 months. |
| Arm II (placebo) | Placebo comparator | Other: PlaceboPatients receive placebo PO QD for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidAlso: n-3 Fatty Acid, Omega 3 Fatty Acid, OMEGA-3 FATTY ACIDS, Omega-3 Polyunsaturated Fatty AcidGiven PO. | Dietary supplement | Arm I (omega-3 fatty acid) |
| PlaceboAlso: placebo therapy, sham therapyGiven PO. | Other | Arm II (placebo) |
Primary outcome
Change in pain score based on the Brief Pain Inventory (BPI)
Time frame: Baseline to up to 6 months
Analysis of patterns of change over time in pain scores through the application of hierarchical linear regression models.
5 secondary outcomes
Change in joint symptoms based on quality of life instruments
Time frame: Baseline to up to 6 months
Change in joint symptoms based on symptomatology instruments
Time frame: Baseline to up to 6 months
Identification and validation of genetic risk predictors for aromatase inhibitor-induced arthralgias
Time frame: Up to 6 months
Rate of compliance
Time frame: Up to 6 months
SNP analysis by standard data preprocessing operations and sequential analysis
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 35005781Roberts 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.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Williams, MD principal investigator
Ohio State University Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acid in people with Arthralgia and Breast Neoplasms, run by Ohio State University Comprehensive Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score based on the Brief Pain Inventory (BPI) (time frame: Baseline to up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02831582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.