Trial Outcomes & Findings for S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy (NCT NCT01385137)
NCT ID: NCT01385137
Last Updated: 2017-04-07
Results Overview
Linear regression model-adjusted week 12 mean score by treatment group. Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10
COMPLETED
PHASE3
262 participants
12 weeks post-registration
2017-04-07
Participant Flow
Participant milestones
| Measure |
Arm I (Omega-3-fatty Acid)
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Evaluable at Baseline
STARTED
|
131
|
131
|
|
Evaluable at Baseline
COMPLETED
|
122
|
127
|
|
Evaluable at Baseline
NOT COMPLETED
|
9
|
4
|
|
Evaluable for Primary Endpoint
STARTED
|
131
|
131
|
|
Evaluable for Primary Endpoint
COMPLETED
|
102
|
107
|
|
Evaluable for Primary Endpoint
NOT COMPLETED
|
29
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy
Baseline characteristics by cohort
| Measure |
Arm I (Omega-3-fatty Acid)
n=122 Participants
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
n=127 Participants
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
n=5 Participants
|
59.1 years
n=7 Participants
|
59.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
113 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Osteoarthritis
Yes
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Osteoarthritis
No
|
94 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-registrationLinear regression model-adjusted week 12 mean score by treatment group. Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10
Outcome measures
| Measure |
Arm I (Omega-3-fatty Acid)
n=102 Participants
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
n=107 Participants
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score
|
5.3 BPI score
Interval 4.68 to 5.91
|
5.47 BPI score
Interval 4.86 to 6.09
|
SECONDARY outcome
Timeframe: Up to 25 weeksPopulation: All participants receiving at least some protocol treatment
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome measures
| Measure |
Arm I (Omega-3-fatty Acid)
n=117 Participants
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
n=124 Participants
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Arthralgia
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Diarrhea
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Dyspepsia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Pain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Pain in extremity
|
1 Participants
|
0 Participants
|
|
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Peripheral motor neuropathy
|
0 Participants
|
1 Participants
|
|
Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Rash maculo-papular
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeks post-registrationLinear regression model-adjusted week 12 mean score by treatment group The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate higher symptom burden.
Outcome measures
| Measure |
Arm I (Omega-3-fatty Acid)
n=102 Participants
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
n=107 Participants
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
|
34.5 WOMAC score
Interval 29.4 to 39.7
|
36.7 WOMAC score
Interval 31.5 to 41.8
|
SECONDARY outcome
Timeframe: 12 weeks post-registrationLinear regression model-adjusted week 12 mean score by treatment group. Higher scores represent higher symptom burden. Range is 0 to 100.
Outcome measures
| Measure |
Arm I (Omega-3-fatty Acid)
n=100 Participants
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
n=107 Participants
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score
|
28.8 M-SACRAH score
Interval 23.9 to 33.7
|
28.1 M-SACRAH score
Interval 23.2 to 33.0
|
SECONDARY outcome
Timeframe: 12 weeks post-registrationFACT-ES measures physical, social and family, emotional, and functional well-being and endocrine symptoms. The FACT scaleshave five response levels ("not at all" to "very much"), where higher scores reflect better well-being and fewer symptoms. This scale provided a measure of the broader impact of join pain and stiffness symptoms. Score range is 0 to 220.
Outcome measures
| Measure |
Arm I (Omega-3-fatty Acid)
n=100 Participants
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
n=107 Participants
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score
|
95 FACT-ES score
Interval 91.7 to 98.3
|
92.8 FACT-ES score
Interval 89.5 to 96.1
|
Adverse Events
Arm I (Omega-3-fatty Acid)
Arm II (Placebo)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Omega-3-fatty Acid)
n=117 participants at risk
Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
|
Arm II (Placebo)
n=124 participants at risk
Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
|
|---|---|---|
|
Gastrointestinal disorders
Bloating
|
6.0%
7/117 • Up to 25 weeks
|
1.6%
2/124 • Up to 25 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
18/117 • Up to 25 weeks
|
8.9%
11/124 • Up to 25 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
19.7%
23/117 • Up to 25 weeks
|
12.9%
16/124 • Up to 25 weeks
|
|
Gastrointestinal disorders
Nausea
|
10.3%
12/117 • Up to 25 weeks
|
13.7%
17/124 • Up to 25 weeks
|
|
General disorders
Fatigue
|
5.1%
6/117 • Up to 25 weeks
|
6.5%
8/124 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
47.0%
55/117 • Up to 25 weeks
|
50.8%
63/124 • Up to 25 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
9.4%
11/117 • Up to 25 weeks
|
12.1%
15/124 • Up to 25 weeks
|
|
Nervous system disorders
Headache
|
2.6%
3/117 • Up to 25 weeks
|
5.6%
7/124 • Up to 25 weeks
|
|
Vascular disorders
Hot flashes
|
3.4%
4/117 • Up to 25 weeks
|
6.5%
8/124 • Up to 25 weeks
|
Additional Information
Study Statistician
SWOG Statistical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place