Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors

• Sponsor: Gary Morrow (Other)
• Overall Status: Completed
• CT.gov ID: NCT02352779
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 108
• Locations: 6
• Arms: 3
• Duration (Months): 14
• Patients Per Site: 18
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma; Cancer; Fatigue	Dietary Supplement: Omega-3 Fatty Acid; Other: Placebo; Other: Questionnaire Administration; Other: Laboratory Biomarker Analysis	N/A

Detailed Description

PRIMARY OBJECTIVE:

1. 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

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Feasibility of Omega-3 Supplementation for Cancer-Related Fatigue
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Omega-3 Fatty Acid; Given PO; Other Names: O3FA Omega-3 Fatty Acids Omega-3 PUFA ; Other: Placebo; Given PO; Other Names: PLCB ; Other: Questionnaire Administration; Ancillary studies; Other: Laboratory Biomarker Analysis; Correlative studies
Experimental: Arm II (high-dose omega-3 fatty acid) Patients receive high-dose omega-3 fatty acid supplementation PO BID for 6 weeks.	Dietary Supplement: Omega-3 Fatty Acid; Given PO; Other Names: O3FA Omega-3 Fatty Acids Omega-3 PUFA ; Other: Questionnaire Administration; Ancillary studies; Other: Laboratory Biomarker Analysis; Correlative studies
Placebo Comparator: Arm III (placebo) Patients receive placebo PO BID for 6 weeks.	Other: Placebo; Given PO; Other Names: PLCB ; Other: Questionnaire Administration; Ancillary studies; Other: Laboratory Biomarker Analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wichita NCORP	Wichita	Kansas	United States	67214
2	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan	United States	49503
3	University of Rochester NCORP Research Base	Rochester	New York	United States	14642
4	Dayton NCORP	Dayton	Ohio	United States	45420
5	Greenville Health System NCORP	Greenville	South Carolina	United States	29605
6	Wisconsin NCORP	Marshfield	Wisconsin	United States	54449

Sponsors and Collaborators

• Gary Morrow
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Luke Peppone, University of Rochester NCORP Research Base

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

None provided.

• Responsible Party: Gary Morrow, Principal Investigator, URCC NCORP Research Base, University of Rochester NCORP Research Base
• ClinicalTrials.gov Identifier: NCT02352779
• Other Study ID Numbers: URCC13091; NCI-2014-01191; URCC13091; URCC-13091; URCC-13091; U10CA037420; UG1CA189961; R03CA175599
• First Posted: Feb 2, 2015
• Last Update Posted: Aug 8, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gary Morrow, Principal Investigator, URCC NCORP Research Base, University of Rochester NCORP Research Base: Cancer Survivor
• Additional relevant MeSH terms: Breast Neoplasms; Fatigue

Study Results

Participant Flow

Arm/Group Title	Arm I (Low-dose Omega-3 Fatty Acid)	Arm II (High-dose Omega-3 Fatty Acid)	Arm III (Placebo)
Arm/Group Description	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	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	Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
Period Title: Overall Study
STARTED	37	36	35
COMPLETED	29	35	33
NOT COMPLETED	8	1	2

Baseline Characteristics

Arm/Group Title	Arm I (Low-dose Omega-3 Fatty Acid)	Arm II (High-dose Omega-3 Fatty Acid)	Arm III (Placebo)	Total
Arm/Group Description	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	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	Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies	Total of all reporting groups
Overall Participants	29	35	33	97
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.62 (11.10)	60.40 (9.35)	58.03 (10.94)	59.66 (10.40)
Sex: Female, Male (Count of Participants)
Female	29 100%	35 100%	33 100%	97 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	28 96.6%	35 100%	33 100%	96 99%
Unknown or Not Reported	1 3.4%	0 0%	0 0%	1 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 3.4%	0 0%	0 0%	1 1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	1 3.4%	4 11.4%	0 0%	5 5.2%
White	27 93.1%	31 88.6%	33 100%	91 93.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.11 (6.07)	32.31 (7.45)	32.64 (8.17)	31.76 (7.34)
Karnofsky Performance Status (KPS) (Karnofsky Performance Scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Karnofsky Performance Scale]	91.38 (5.81)	92.00 (6.32)	89.70 (7.70)	91.03 (6.69)
Education Level (Count of Participants)
Graduate Degree	6 20.7%	5 14.3%	4 12.1%	15 15.5%
2 or 4 year Degree / Some college	13 44.8%	18 51.4%	14 42.4%	45 46.4%
HS / GED Degree	10 34.5%	12 34.3%	14 42.4%	36 37.1%
No HS Degree or GED	0 0%	0 0%	1 3%	1 1%
Marital Status (Count of Participants)
Married	16 55.2%	20 57.1%	25 75.8%	61 62.9%
Long Term, Committed SO	2 6.9%	0 0%	3 9.1%	5 5.2%
Divorced	5 17.2%	7 20%	0 0%	12 12.4%
Single	3 10.3%	4 11.4%	2 6.1%	9 9.3%
Widowed	3 10.3%	4 11.4%	3 9.1%	10 10.3%
Employment Status (Current) (Count of Participants)
Employment outside the house	16 55.2%	18 51.4%	13 39.4%	47 48.5%
Self Employed	3 10.3%	3 8.6%	0 0%	6 6.2%
Home Maker	6 20.7%	3 8.6%	9 27.3%	18 18.6%
Unemployed	4 13.8%	11 31.4%	11 33.3%	26 26.8%
Previous Treatment - Surgery (Count of Participants)
Yes	28 96.6%	33 94.3%	33 100%	94 96.9%
No	1 3.4%	2 5.7%	0 0%	3 3.1%
Previous Treatment - Chemotherapy (Count of Participants)
Yes	13 44.8%	19 54.3%	17 51.5%	49 50.5%
No	16 55.2%	16 45.7%	16 48.5%	48 49.5%
Previous Treatment - Radiation (Count of Participants)
Yes	19 65.5%	28 80%	25 75.8%	72 74.2%
No	10 34.5%	7 20%	8 24.2%	25 25.8%
Previous Treatment - Hormone Therapy (Count of Participants)
Yes	2 6.9%	6 17.1%	9 27.3%	17 17.5%
No	27 93.1%	29 82.9%	24 72.7%	80 82.5%

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Low-dose Omega-3 Fatty Acid)	Arm II (High-dose Omega-3 Fatty Acid)	Arm III (Placebo)
Arm/Group Description	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	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	Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
Measure Participants	24	30	27
BFI-SF Mean Post - Pre	-3.66	-3.68	-2.99
MFSI-SF Mean Post - Pre	-11.03	-13.93	-10.94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Low-dose Omega-3 Fatty Acid), Arm III (Placebo)
	Comments	BFI-SF
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1666
	Comments
	Method	ANCOVA
	Comments	Based on a contrast using the three-arm ANCOVA.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.6763
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4843
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm II (High-dose Omega-3 Fatty Acid), Arm III (Placebo)
	Comments	BFI-SF
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1329
	Comments
	Method	ANCOVA
	Comments	Based on a contrast using the three-arm ANCOVA.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.6936
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4567
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Arm I (Low-dose Omega-3 Fatty Acid), Arm III (Placebo)
	Comments	MFSI-SF
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9826
	Comments
	Method	ANCOVA
	Comments	Based on a contrast using the three-arm ANCOVA.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.0831
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.8065
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Arm II (High-dose Omega-3 Fatty Acid), Arm III (Placebo)
	Comments	MFSI-SF
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4016
	Comments
	Method	ANCOVA
	Comments	Based on a contrast using the three-arm ANCOVA.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.9898
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.5448
	Estimation Comments

Adverse Events

Arm/Group Title	Arm I (Low-dose Omega-3 Fatty Acid)		Arm II (High-dose Omega-3 Fatty Acid)		Arm III (Placebo)
Arm/Group Description	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		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		Patients receive placebo PO BID for 6 weeks. Placebo: Given PO Questionnaire Administration: Ancillary studies Laboratory Biomarker Analysis: Correlative studies
All Cause Mortality
	Arm I (Low-dose Omega-3 Fatty Acid)		Arm II (High-dose Omega-3 Fatty Acid)		Arm III (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I (Low-dose Omega-3 Fatty Acid)		Arm II (High-dose Omega-3 Fatty Acid)		Arm III (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/35 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (Low-dose Omega-3 Fatty Acid)		Arm II (High-dose Omega-3 Fatty Acid)		Arm III (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/35 (0%)		1/33 (3%)
Skin and subcutaneous tissue disorders
Pruritis	0/29 (0%)	0	0/35 (0%)	0	1/33 (3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.