Trial Outcomes & Findings for Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors (NCT NCT02352779)
NCT ID: NCT02352779
Last Updated: 2017-08-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
Baseline to 6 weeks
Results posted on
2017-08-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Arm III (Placebo)
Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
36
|
35
|
|
Overall Study
COMPLETED
|
29
|
35
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
Arm III (Placebo)
Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Overall Study
Personal Issues
|
1
|
1
|
0
|
|
Overall Study
Too Many Forms
|
2
|
0
|
0
|
|
Overall Study
Feeling Overwhelmed
|
1
|
0
|
0
|
|
Overall Study
Disliked Intervention
|
1
|
0
|
0
|
|
Overall Study
Changed Mind
|
1
|
0
|
0
|
|
Overall Study
Study Related Symptoms
|
1
|
0
|
0
|
|
Overall Study
Absence of Symptoms
|
1
|
0
|
0
|
|
Overall Study
Other Medical Reason
|
0
|
0
|
1
|
|
Overall Study
No Reason
|
0
|
0
|
1
|
Baseline Characteristics
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm I (Low-dose Omega-3 Fatty Acid)
n=29 Participants
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
|
Arm II (High-dose Omega-3 Fatty Acid)
n=35 Participants
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
|
Arm III (Placebo)
n=33 Participants
Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.62 years
STANDARD_DEVIATION 11.10 • n=99 Participants
|
60.40 years
STANDARD_DEVIATION 9.35 • n=107 Participants
|
58.03 years
STANDARD_DEVIATION 10.94 • n=206 Participants
|
59.66 years
STANDARD_DEVIATION 10.40 • n=7 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
97 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
91 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
BMI
|
30.11 kg/m^2
STANDARD_DEVIATION 6.07 • n=99 Participants
|
32.31 kg/m^2
STANDARD_DEVIATION 7.45 • n=107 Participants
|
32.64 kg/m^2
STANDARD_DEVIATION 8.17 • n=206 Participants
|
31.76 kg/m^2
STANDARD_DEVIATION 7.34 • n=7 Participants
|
|
Karnofsky Performance Status (KPS)
|
91.38 Karnofsky Performance Scale
STANDARD_DEVIATION 5.81 • n=99 Participants
|
92.00 Karnofsky Performance Scale
STANDARD_DEVIATION 6.32 • n=107 Participants
|
89.70 Karnofsky Performance Scale
STANDARD_DEVIATION 7.70 • n=206 Participants
|
91.03 Karnofsky Performance Scale
STANDARD_DEVIATION 6.69 • n=7 Participants
|
|
Education Level
Graduate Degree
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Education Level
2 or 4 year Degree / Some college
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Education Level
HS / GED Degree
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Education Level
No HS Degree or GED
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Marital Status
Married
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
|
Marital Status
Long Term, Committed SO
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Marital Status
Divorced
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Marital Status
Single
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Marital Status
Widowed
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Employment Status (Current)
Employment outside the house
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Employment Status (Current)
Self Employed
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Employment Status (Current)
Home Maker
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Employment Status (Current)
Unemployed
|
4 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Previous Treatment - Surgery
Yes
|
28 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
|
Previous Treatment - Surgery
No
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Previous Treatment - Chemotherapy
Yes
|
13 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
|
Previous Treatment - Chemotherapy
No
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Previous Treatment - Radiation
Yes
|
19 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Previous Treatment - Radiation
No
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Previous Treatment - Hormone Therapy
Yes
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Previous Treatment - Hormone Therapy
No
|
27 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
80 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 weeksBFI-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).
Outcome measures
| Measure |
Arm I (Low-dose Omega-3 Fatty Acid)
n=24 Participants
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
|
Arm II (High-dose Omega-3 Fatty Acid)
n=30 Participants
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
|
Arm III (Placebo)
n=27 Participants
Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
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
Interval -4.37 to -2.96
|
-3.68 units on a scale
Interval -4.31 to -3.05
|
-2.99 units on a scale
Interval -3.65 to -2.33
|
|
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
Interval -16.55 to -5.5
|
-13.93 units on a scale
Interval -18.82 to -9.05
|
-10.94 units on a scale
Interval -16.07 to -5.82
|
Adverse Events
Arm I (Low-dose Omega-3 Fatty Acid)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (High-dose Omega-3 Fatty Acid)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm III (Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Low-dose Omega-3 Fatty Acid)
n=29 participants at risk
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
|
Arm II (High-dose Omega-3 Fatty Acid)
n=35 participants at risk
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
|
Arm III (Placebo)
n=33 participants at risk
Patients receive placebo PO BID for 6 weeks.
Placebo: Given PO
Questionnaire Administration: Ancillary studies
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/29
|
0.00%
0/35
|
3.0%
1/33 • Number of events 1
|
Additional Information
Luke J. Peppone, PhD, MPH. Assistant Professor
University of Rochester Medical Center
Phone: 585-275-7827
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place