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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01191 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC13091 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-13091 | Other Identifier | DCP | |
| URCC-13091 | Other Identifier | CTEP | |
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source | |
| R03CA175599 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVE:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Arm II (high-dose omega-3 fatty acid) | Experimental | Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. |
|
| Arm III (placebo) | Placebo Comparator | Patients receive placebo PO BID for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 Fatty Acid | Dietary Supplement | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luke Peppone | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wichita NCORP | Wichita | Kansas | 67214 | United States | ||
| Cancer Research Consortium of West Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35416182 | Derived | 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. | |
| 32812824 | Derived | Inglis 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. |
| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Low-dose Omega-3 Fatty Acid) | Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks. Omega-3 Fatty Acid: Given PO Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | Given PO |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Grand Rapids |
| Michigan |
| 49503 |
| United States |
| University of Rochester NCORP Research Base | Rochester | New York | 14642 | United States |
| Dayton NCORP | Dayton | Ohio | 45420 | United States |
| Greenville Health System NCORP | Greenville | South Carolina | 29605 | United States |
| Wisconsin NCORP | Marshfield | Wisconsin | 54449 | United States |
| Arm II (High-dose Omega-3 Fatty Acid) |
Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. Omega-3 Fatty Acid: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| FG002 | Arm III (Placebo) | Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Low-dose Omega-3 Fatty Acid) | Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks. Omega-3 Fatty Acid: Given PO Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| BG001 | Arm II (High-dose Omega-3 Fatty Acid) | Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. Omega-3 Fatty Acid: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| BG002 | Arm III (Placebo) | Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Karnofsky Performance Status (KPS) | The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. Essentially as used in oncology, the KPS is a measure of time to death. A higher score is favorable. There are 3 general categories which are broken down into 11 specific criteria. Scale range is from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease). The scale increases in units of 10. | Mean | Standard Deviation | Karnofsky Performance Scale |
| ||||||||||||||
| Education Level | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
| ||||||||||||||||
| Employment Status (Current) | Count of Participants | Participants |
| ||||||||||||||||
| Previous Treatment - Surgery | Count of Participants | Participants |
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| Previous Treatment - Chemotherapy | Count of Participants | Participants |
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| Previous Treatment - Radiation | Count of Participants | Participants |
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| Previous Treatment - Hormone Therapy | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Low-dose Omega-3 Fatty Acid) | Patients receive low-dose omega-3 fatty acid supplementation PO BID and placebo PO BID for 6 weeks. Omega-3 Fatty Acid: Given PO Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies | 0 | 29 | 0 | 29 | ||
| EG001 | Arm II (High-dose Omega-3 Fatty Acid) | Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks. Omega-3 Fatty Acid: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies | 0 | 35 | 0 | 35 | ||
| EG002 | Arm III (Placebo) | Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies | 0 | 33 | 1 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luke J. Peppone, PhD, MPH. Assistant Professor | University of Rochester Medical Center | 585-275-7827 | Luke_Peppone@urmc.rochester.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 or 4 year Degree / Some college |
|
| HS / GED Degree |
|
| No HS Degree or GED |
|
| Long Term, Committed SO |
|
| Divorced |
|
| Single |
|
| Widowed |
|
| Self Employed |
|
| Home Maker |
|
| Unemployed |
|
| No |
|
| No |
|
| No |
|
| No |
|
|
| ANCOVA |
Based on a contrast using the three-arm ANCOVA. |
| 0.1329 |
| Mean Difference (Final Values) |
| 0.6936 |
| Standard Error of the Mean |
| 0.4567 |
| 2-Sided |
| Other |
| MFSI-SF | ANCOVA | Based on a contrast using the three-arm ANCOVA. | 0.9826 | Mean Difference (Final Values) | 0.0831 | Standard Error of the Mean | 3.8065 | 2-Sided | Other |
| MFSI-SF | ANCOVA | Based on a contrast using the three-arm ANCOVA. | 0.4016 | Mean Difference (Final Values) | 2.9898 | Standard Error of the Mean | 3.5448 | 2-Sided | Other |