Breast CarcinomaNCT02352779
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
A study testing Omega-3 Fatty Acid, Questionnaire Administration and Laboratory Biomarker Analysis in people with Breast Carcinoma and Cancer, run by Gary Morrow at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Carcinoma, Cancer, Fatigue
- What is being tested?
- Omega-3 Fatty Acid, Questionnaire Administration and Laboratory Biomarker Analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Dayton NCORP
Dayton, Ohio, 45420
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, 49503
Greenville Health System NCORP
Greenville, South Carolina, 29605
Wisconsin NCORP
Marshfield, Wisconsin, 54449
University of Rochester NCORP Research Base
Rochester, New York, 14642
Wichita NCORP
Wichita, Kansas, 67214
About this study
Official title: Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
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.
- Conditions
- Breast Carcinoma, Cancer, Fatigue
- Being tested
- Omega-3 Fatty Acid, Placebo, Questionnaire Administration, Laboratory Biomarker Analysis
- Keywords
- Cancer Survivor
- Medical subject headings
- Breast Neoplasms, Neoplasms, Fatigue
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 O3FA, Omega-3 Fatty Acids, Omega-3 PUFA
Given PO
PlaceboOther
Also called PLCB
Given PO
Questionnaire AdministrationOther
Ancillary studies
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (low-dose omega-3 fatty acid) | Experimental | Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks. Receives: Dietary Supplement: Omega-3 Fatty Acid; Other: Placebo; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis |
| Arm II (high-dose omega-3 fatty acid) | Experimental | Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. Receives: Dietary Supplement: Omega-3 Fatty Acid; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis |
| Arm III (placebo) | Placebo comparator | Patients receive placebo PO BID for 6 weeks. Receives: Other: Placebo; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).
MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary Morrow
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Gary Morrow, University of Rochester NCORP Research Base
- Investigators
- Luke Peppone, Principal investigator, University of Rochester NCORP Research Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352779
- Sponsor's protocol ID
- URCC13091
- Other IDs
- NCI-2014-01191, URCC13091, URCC-13091, URCC-13091, U10CA037420, UG1CA189961, R03CA175599
- Status last verified
- Jul 2017
- First submitted
- 28 Jan 2015
- Last updated
- 8 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kleckner AS, Kleckner IR, Culakova E, Wojtovich AP, Klinedinst NJ, Kerns SL, Hardy SJ, Inglis JE, Padula GDA, Mustian KM, Janelsins MC, Dorsey SG, Saligan LN, Peppone LJ. Exploratory Analysis of Associations Between Whole Blood Mitochondrial Gene Expression and Cancer-Related Fatigue Among Breast Cancer Survivors. Nurs Res. 2022 Sep-Oct 01;71(5):411-417. doi: 10.1097/NNR.0000000000000598. Epub 2022 Apr 13.
PubMed 35416182Inglis JE, Kleckner AS, Lin PJ, Gilmore NJ, Culakova E, VanderWoude AC, Mustian KM, Fernandez ID, Dunne RF, Deutsch J, Peppone LJ. Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids in Breast Cancer Survivors. Nutr Cancer. 2021;73(9):1676-1686. doi: 10.1080/01635581.2020.1807574. Epub 2020 Aug 19.
PubMed 32812824
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
- ClinicalTrials.gov ID
- NCT02352779
- Acronym / sponsor ID
- URCC13091
- Conditions
- Breast Carcinoma, Cancer, Fatigue
- Keywords
- Cancer Survivor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Gary MorrowUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Feb 2015 (estimated)
- Results
- Posted 8 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (low-dose omega-3 fatty acid) | Experimental | Dietary Supplement: Omega-3 Fatty Acid, Other: Placebo, Other: Questionnaire Administration, Other: Laboratory Biomarker AnalysisPatients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks. |
| Arm II (high-dose omega-3 fatty acid) | Experimental | Dietary Supplement: Omega-3 Fatty Acid, Other: Questionnaire Administration, Other: Laboratory Biomarker AnalysisPatients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. |
| Arm III (placebo) | Placebo comparator | Other: Placebo, Other: Questionnaire Administration, Other: Laboratory Biomarker AnalysisPatients receive placebo PO BID for 6 weeks. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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: O3FA, Omega-3 Fatty Acids, Omega-3 PUFAGiven PO | Dietary supplement | Arm I (low-dose omega-3 fatty acid), Arm II (high-dose omega-3 fatty acid) |
| PlaceboAlso: PLCBGiven PO | Other | Arm I (low-dose omega-3 fatty acid), Arm III (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (low-dose omega-3 fatty acid), Arm II (high-dose omega-3 fatty acid), Arm III (placebo) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (low-dose omega-3 fatty acid), Arm II (high-dose omega-3 fatty acid), Arm III (placebo) |
Primary outcome
Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value
Time frame: Baseline to 6 weeks
BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine). MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35416182Kleckner AS, Kleckner IR, Culakova E, Wojtovich AP, Klinedinst NJ, Kerns SL, Hardy SJ, Inglis JE, Padula GDA, Mustian KM, Janelsins MC, Dorsey SG, Saligan LN, Peppone LJ. Exploratory Analysis of Associations Between Whole Blood Mitochondrial Gene Expression and Cancer-Related Fatigue Among Breast Cancer Survivors. Nurs Res. 2022 Sep-Oct 01;71(5):411-417. doi: 10.1097/NNR.0000000000000598. Epub 2022 Apr 13.
- Derived from this study: PubMed 32812824Inglis JE, Kleckner AS, Lin PJ, Gilmore NJ, Culakova E, VanderWoude AC, Mustian KM, Fernandez ID, Dunne RF, Deutsch J, Peppone LJ. Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids in Breast Cancer Survivors. Nutr Cancer. 2021;73(9):1676-1686. doi: 10.1080/01635581.2020.1807574. Epub 2020 Aug 19.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink 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.
Luke Peppone principal investigator
University of Rochester NCORP Research Base
6 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, Questionnaire Administration and Laboratory Biomarker Analysis in people with Breast Carcinoma and Cancer, run by Gary Morrow at 6 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 7 inclusion and 5 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 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 8 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value (time frame: Baseline to 6 weeks). 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 NCT02352779, which also lists 2 linked publications.
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 8 Aug 2017.