Breast Carcinoma, Cancer, Fatigue
Conditions
Keywords
Cancer Survivor
Brief 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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 Fatty Acid
Given PO
OTHERPlacebo
Given PO
OTHERQuestionnaire Administration
Ancillary studies
OTHERLaboratory Biomarker Analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Gary Morrow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 29 |
| 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 | 35 |
| Arm III (Placebo) Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies | 33 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Absence of Symptoms | 1 | 0 | 0 |
| Overall Study | Changed Mind | 1 | 0 | 0 |
| Overall Study | Disliked Intervention | 1 | 0 | 0 |
| Overall Study | Feeling Overwhelmed | 1 | 0 | 0 |
| Overall Study | No Reason | 0 | 0 | 1 |
| Overall Study | Other Medical Reason | 0 | 0 | 1 |
| Overall Study | Personal Issues | 1 | 1 | 0 |
| Overall Study | Study Related Symptoms | 1 | 0 | 0 |
| Overall Study | Too Many Forms | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm II (High-dose Omega-3 Fatty Acid) | Arm III (Placebo) | Arm I (Low-dose Omega-3 Fatty Acid) | Total |
|---|---|---|---|---|
| Age, Continuous | 60.40 years STANDARD_DEVIATION 9.35 | 58.03 years STANDARD_DEVIATION 10.94 | 60.62 years STANDARD_DEVIATION 11.1 | 59.66 years STANDARD_DEVIATION 10.4 |
| BMI | 32.31 kg/m^2 STANDARD_DEVIATION 7.45 | 32.64 kg/m^2 STANDARD_DEVIATION 8.17 | 30.11 kg/m^2 STANDARD_DEVIATION 6.07 | 31.76 kg/m^2 STANDARD_DEVIATION 7.34 |
| Education Level 2 or 4 year Degree / Some college | 18 Participants | 14 Participants | 13 Participants | 45 Participants |
| Education Level Graduate Degree | 5 Participants | 4 Participants | 6 Participants | 15 Participants |
| Education Level HS / GED Degree | 12 Participants | 14 Participants | 10 Participants | 36 Participants |
| Education Level No HS Degree or GED | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Employment Status (Current) Employment outside the house | 18 Participants | 13 Participants | 16 Participants | 47 Participants |
| Employment Status (Current) Home Maker | 3 Participants | 9 Participants | 6 Participants | 18 Participants |
| Employment Status (Current) Self Employed | 3 Participants | 0 Participants | 3 Participants | 6 Participants |
| Employment Status (Current) Unemployed | 11 Participants | 11 Participants | 4 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 33 Participants | 28 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Karnofsky Performance Status (KPS) | 92.00 Karnofsky Performance Scale STANDARD_DEVIATION 6.32 | 89.70 Karnofsky Performance Scale STANDARD_DEVIATION 7.7 | 91.38 Karnofsky Performance Scale STANDARD_DEVIATION 5.81 | 91.03 Karnofsky Performance Scale STANDARD_DEVIATION 6.69 |
| Marital Status Divorced | 7 Participants | 0 Participants | 5 Participants | 12 Participants |
| Marital Status Long Term, Committed SO | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Marital Status Married | 20 Participants | 25 Participants | 16 Participants | 61 Participants |
| Marital Status Single | 4 Participants | 2 Participants | 3 Participants | 9 Participants |
| Marital Status Widowed | 4 Participants | 3 Participants | 3 Participants | 10 Participants |
| Previous Treatment - Chemotherapy No | 16 Participants | 16 Participants | 16 Participants | 48 Participants |
| Previous Treatment - Chemotherapy Yes | 19 Participants | 17 Participants | 13 Participants | 49 Participants |
| Previous Treatment - Hormone Therapy No | 29 Participants | 24 Participants | 27 Participants | 80 Participants |
| Previous Treatment - Hormone Therapy Yes | 6 Participants | 9 Participants | 2 Participants | 17 Participants |
| Previous Treatment - Radiation No | 7 Participants | 8 Participants | 10 Participants | 25 Participants |
| Previous Treatment - Radiation Yes | 28 Participants | 25 Participants | 19 Participants | 72 Participants |
| Previous Treatment - Surgery No | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Previous Treatment - Surgery Yes | 33 Participants | 33 Participants | 28 Participants | 94 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 33 Participants | 27 Participants | 91 Participants |
| Sex: Female, Male Female | 35 Participants | 33 Participants | 29 Participants | 97 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 35 | 1 / 33 |
| serious Total, serious adverse events | 0 / 29 | 0 / 35 | 0 / 33 |
Outcome results
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).
Time frame: Baseline to 6 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Arm I (Low-dose Omega-3 Fatty Acid) | 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 Mean Post - Pre | -3.66 units on a scale |
| Arm I (Low-dose Omega-3 Fatty Acid) | 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 | MFSI-SF Mean Post - Pre | -11.03 units on a scale |
| Arm II (High-dose Omega-3 Fatty Acid) | 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 Mean Post - Pre | -3.68 units on a scale |
| Arm II (High-dose Omega-3 Fatty Acid) | 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 | MFSI-SF Mean Post - Pre | -13.93 units on a scale |
| Arm III (Placebo) | 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 Mean Post - Pre | -2.99 units on a scale |
| Arm III (Placebo) | 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 | MFSI-SF Mean Post - Pre | -10.94 units on a scale |
Comparison: BFI-SFp-value: 0.1666ANCOVA
Comparison: BFI-SFp-value: 0.1329ANCOVA
Comparison: MFSI-SFp-value: 0.9826ANCOVA
Comparison: MFSI-SFp-value: 0.4016ANCOVA