Trial Outcomes & Findings for Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer (NCT NCT00096356)
NCT ID: NCT00096356
Last Updated: 2021-09-29
Results Overview
POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
236 participants
Primary outcome timeframe
24 weeks
Results posted on
2021-09-29
Participant Flow
Recruitment occurred in medical clinics
There was no run-in period. Everyone enrolled was randomized.
Participant milestones
| Measure |
Arm 1 - CoQ10 + Vitamin E
CoQ10 + Vitamin E 100mg/day in 3 doses
|
Arm 2 - Placebo + Vitamin E
Placebo + Vitamin E 100mg/day in 3 doses
|
|---|---|---|
|
Overall Study
STARTED
|
122
|
114
|
|
Overall Study
COMPLETED
|
78
|
61
|
|
Overall Study
NOT COMPLETED
|
44
|
53
|
Reasons for withdrawal
| Measure |
Arm 1 - CoQ10 + Vitamin E
CoQ10 + Vitamin E 100mg/day in 3 doses
|
Arm 2 - Placebo + Vitamin E
Placebo + Vitamin E 100mg/day in 3 doses
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
9
|
|
Overall Study
Physician Decision
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
17
|
23
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
multiple reasons
|
10
|
18
|
Baseline Characteristics
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 - CoQ10 & Vitamin E
n=122 Participants
CoQ10 plus Vitamin E 100mg/day in 3 doses
|
Arm 2 - Placebo & Vitamin E
n=114 Participants
Placebo plus Vitamin E 100mg/day in 3 doses
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
108 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
50.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
104 participants
n=5 Participants
|
102 participants
n=7 Participants
|
206 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=5 Participants
|
114 participants
n=7 Participants
|
236 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPOMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
Outcome measures
| Measure |
Arm 1 - CoQ10 & Vitamin E
n=122 Participants
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
|
Arm 2 - Placebo & Vitamin E
n=114 Participants
Placebo-Vitamin E 100 mg/day in 3 doses
|
|---|---|---|
|
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
|
6.96 units on a scale
Standard Error 0.71
|
8.33 units on a scale
Standard Error 0.79
|
SECONDARY outcome
Timeframe: 24 weeksFACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.
Outcome measures
| Measure |
Arm 1 - CoQ10 & Vitamin E
n=122 Participants
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
|
Arm 2 - Placebo & Vitamin E
n=114 Participants
Placebo-Vitamin E 100 mg/day in 3 doses
|
|---|---|---|
|
Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
|
111.8 units on a scale
Standard Error 1.81
|
109.8 units on a scale
Standard Error 1.96
|
SECONDARY outcome
Timeframe: 24 weeksCES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.
Outcome measures
| Measure |
Arm 1 - CoQ10 & Vitamin E
n=122 Participants
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
|
Arm 2 - Placebo & Vitamin E
n=114 Participants
Placebo-Vitamin E 100 mg/day in 3 doses
|
|---|---|---|
|
Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
|
11.7 units on a scale
Standard Error 0.96
|
12.4 units on a scale
Standard Error 1.05
|
Adverse Events
Arm 1 - CoQ10 & Vitamin E
Serious events: 22 serious events
Other events: 89 other events
Deaths: 0 deaths
Arm 2 - Placebo & Vitamin E
Serious events: 15 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1 - CoQ10 & Vitamin E
n=100 participants at risk
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
|
Arm 2 - Placebo & Vitamin E
n=93 participants at risk
Placebo-Vitamin E 100 mg/day in 3 doses
|
|---|---|---|
|
Blood and lymphatic system disorders
ANC
|
11.0%
11/100 • Number of events 12 • 28 weeks
One month past the end of treatment
|
4.3%
4/93 • Number of events 4 • 28 weeks
One month past the end of treatment
|
|
Blood and lymphatic system disorders
WBC
|
4.0%
4/100 • Number of events 4 • 28 weeks
One month past the end of treatment
|
2.2%
2/93 • Number of events 2 • 28 weeks
One month past the end of treatment
|
|
General disorders
allergic reaction
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
Blood and lymphatic system disorders
anemia
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
2.0%
2/100 • Number of events 2 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
Gastrointestinal disorders
constipation
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
|
Metabolism and nutrition disorders
dehydration
|
3.0%
3/100 • Number of events 4 • 28 weeks
One month past the end of treatment
|
2.2%
2/93 • Number of events 2 • 28 weeks
One month past the end of treatment
|
|
Gastrointestinal disorders
diarrhea
|
3.0%
3/100 • Number of events 3 • 28 weeks
One month past the end of treatment
|
2.2%
2/93 • Number of events 2 • 28 weeks
One month past the end of treatment
|
|
Nervous system disorders
dizziness
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
General disorders
fatigue
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
3.2%
3/93 • Number of events 4 • 28 weeks
One month past the end of treatment
|
|
General disorders
fever
|
2.0%
2/100 • Number of events 2 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
|
Cardiac disorders
hypotension
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
Gastrointestinal disorders
ileus
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
Infections and infestations
infection
|
2.0%
2/100 • Number of events 2 • 28 weeks
One month past the end of treatment
|
3.2%
3/93 • Number of events 4 • 28 weeks
One month past the end of treatment
|
|
General disorders
pain
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
2.2%
2/93 • Number of events 3 • 28 weeks
One month past the end of treatment
|
|
Gastrointestinal disorders
vomiting
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
|
Cardiac disorders
L vent sy d
|
0.00%
0/100 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
|
Gastrointestinal disorders
abd pain
|
0.00%
0/100 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
|
Cardiac disorders
chest pain
|
0.00%
0/100 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
|
General disorders
hot flashes
|
0.00%
0/100 • 28 weeks
One month past the end of treatment
|
2.2%
2/93 • Number of events 4 • 28 weeks
One month past the end of treatment
|
|
Gastrointestinal disorders
nausea
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
3.2%
3/93 • Number of events 3 • 28 weeks
One month past the end of treatment
|
|
Skin and subcutaneous tissue disorders
rash
|
2.0%
2/100 • Number of events 2 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
|
General disorders
headache
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
0.00%
0/93 • 28 weeks
One month past the end of treatment
|
|
General disorders
insomnia
|
0.00%
0/100 • 28 weeks
One month past the end of treatment
|
1.1%
1/93 • Number of events 1 • 28 weeks
One month past the end of treatment
|
Other adverse events
| Measure |
Arm 1 - CoQ10 & Vitamin E
n=100 participants at risk
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
|
Arm 2 - Placebo & Vitamin E
n=93 participants at risk
Placebo-Vitamin E 100 mg/day in 3 doses
|
|---|---|---|
|
General disorders
alopecia
|
8.0%
8/100 • Number of events 16 • 28 weeks
One month past the end of treatment
|
11.8%
11/93 • Number of events 19 • 28 weeks
One month past the end of treatment
|
|
General disorders
anorexia
|
11.0%
11/100 • Number of events 13 • 28 weeks
One month past the end of treatment
|
5.4%
5/93 • Number of events 7 • 28 weeks
One month past the end of treatment
|
|
General disorders
arthralgia
|
6.0%
6/100 • Number of events 10 • 28 weeks
One month past the end of treatment
|
2.2%
2/93 • Number of events 3 • 28 weeks
One month past the end of treatment
|
|
General disorders
constipation
|
13.0%
13/100 • Number of events 18 • 28 weeks
One month past the end of treatment
|
5.4%
5/93 • Number of events 7 • 28 weeks
One month past the end of treatment
|
|
General disorders
cough
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
6.5%
6/93 • Number of events 8 • 28 weeks
One month past the end of treatment
|
|
General disorders
diarrhea
|
13.0%
13/100 • Number of events 17 • 28 weeks
One month past the end of treatment
|
18.3%
17/93 • Number of events 22 • 28 weeks
One month past the end of treatment
|
|
General disorders
dizziness
|
13.0%
13/100 • Number of events 15 • 28 weeks
One month past the end of treatment
|
15.1%
14/93 • Number of events 15 • 28 weeks
One month past the end of treatment
|
|
General disorders
edema
|
4.0%
4/100 • Number of events 4 • 28 weeks
One month past the end of treatment
|
10.8%
10/93 • Number of events 13 • 28 weeks
One month past the end of treatment
|
|
General disorders
fatigue
|
48.0%
48/100 • Number of events 83 • 28 weeks
One month past the end of treatment
|
50.5%
47/93 • Number of events 80 • 28 weeks
One month past the end of treatment
|
|
General disorders
fever
|
2.0%
2/100 • Number of events 2 • 28 weeks
One month past the end of treatment
|
5.4%
5/93 • Number of events 5 • 28 weeks
One month past the end of treatment
|
|
General disorders
headache
|
16.0%
16/100 • Number of events 23 • 28 weeks
One month past the end of treatment
|
24.7%
23/93 • Number of events 31 • 28 weeks
One month past the end of treatment
|
|
General disorders
heartburn
|
30.0%
30/100 • Number of events 48 • 28 weeks
One month past the end of treatment
|
29.0%
27/93 • Number of events 31 • 28 weeks
One month past the end of treatment
|
|
General disorders
hot flashes
|
5.0%
5/100 • Number of events 6 • 28 weeks
One month past the end of treatment
|
7.5%
7/93 • Number of events 9 • 28 weeks
One month past the end of treatment
|
|
General disorders
infection
|
4.0%
4/100 • Number of events 6 • 28 weeks
One month past the end of treatment
|
5.4%
5/93 • Number of events 5 • 28 weeks
One month past the end of treatment
|
|
General disorders
insomnia
|
34.0%
34/100 • Number of events 53 • 28 weeks
One month past the end of treatment
|
28.0%
26/93 • Number of events 44 • 28 weeks
One month past the end of treatment
|
|
General disorders
irritability
|
13.0%
13/100 • Number of events 16 • 28 weeks
One month past the end of treatment
|
14.0%
13/93 • Number of events 21 • 28 weeks
One month past the end of treatment
|
|
General disorders
mucositis
|
11.0%
11/100 • Number of events 12 • 28 weeks
One month past the end of treatment
|
6.5%
6/93 • Number of events 7 • 28 weeks
One month past the end of treatment
|
|
General disorders
myalgia
|
5.0%
5/100 • Number of events 5 • 28 weeks
One month past the end of treatment
|
5.4%
5/93 • Number of events 7 • 28 weeks
One month past the end of treatment
|
|
General disorders
nausea
|
59.0%
59/100 • Number of events 75 • 28 weeks
One month past the end of treatment
|
55.9%
52/93 • Number of events 71 • 28 weeks
One month past the end of treatment
|
|
General disorders
neuropathy
|
13.0%
13/100 • Number of events 19 • 28 weeks
One month past the end of treatment
|
10.8%
10/93 • Number of events 15 • 28 weeks
One month past the end of treatment
|
|
General disorders
pain
|
15.0%
15/100 • Number of events 22 • 28 weeks
One month past the end of treatment
|
14.0%
13/93 • Number of events 20 • 28 weeks
One month past the end of treatment
|
|
General disorders
rash
|
12.0%
12/100 • Number of events 15 • 28 weeks
One month past the end of treatment
|
20.4%
19/93 • Number of events 27 • 28 weeks
One month past the end of treatment
|
|
General disorders
tachycardia
|
1.0%
1/100 • Number of events 1 • 28 weeks
One month past the end of treatment
|
5.4%
5/93 • Number of events 5 • 28 weeks
One month past the end of treatment
|
|
General disorders
vomiting
|
9.0%
9/100 • Number of events 9 • 28 weeks
One month past the end of treatment
|
10.8%
10/93 • Number of events 10 • 28 weeks
One month past the end of treatment
|
Additional Information
Dr. Glenn Lesser
Wake Forest University Comprehensive Cancer Center
Phone: (336) 713-5440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place