Trial Outcomes & Findings for The Role of Serotonin in Hot Flashes After Breast Cancer (NCT NCT00228943)
NCT ID: NCT00228943
Last Updated: 2015-04-14
Results Overview
Mean serum tryptophan levels (blood draw) at the end of the nadir period.
COMPLETED
NA
28 participants
baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours
2015-04-14
Participant Flow
Subjects were recruited from a Midwestern outpatient cancer clinic from 2005 to 2007.
260 women were screened, 39 of whom were not interested, 162 were found ineligible.
Participant milestones
| Measure |
Full Strength Acute Tryptophan Depletion and Control
Subjects were randomized to receive both a full-strength acute tryptophan depletion drink and half-strength tryptophan depletion drink (control). Some participants received the full-strength drink first for week 1 and then crossed-over to the half-strength (control) drink for week 2; the other participants received the half-strength (control) drink for week 1 and then crossed over to the full-strength drink for week 2.
|
|---|---|
|
Week 1
STARTED
|
28
|
|
Week 1
COMPLETED
|
28
|
|
Week 1
NOT COMPLETED
|
0
|
|
Week 2
STARTED
|
28
|
|
Week 2
COMPLETED
|
27
|
|
Week 2
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Serotonin in Hot Flashes After Breast Cancer
Baseline characteristics by cohort
| Measure |
Entire Sample
n=28 Participants
Consented subjects in the entire sample were randomized to one of two groups for the cross-over design study. One group of subjects received a full-strength tryptophan depletion drink during week 1 followed by a half-strength (control) drink week 2. The other group of subjects received a half-strength tryptophan depletion (control) drink during week 1 followed by a full-strength drink week 2.
The final analysis combined groups to compare full strength versus control.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 9.6 • n=39 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: baseline, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hoursPopulation: The number of subjects with complete serum data for both arms of the study were analyzed.
Mean serum tryptophan levels (blood draw) at the end of the nadir period.
Outcome measures
| Measure |
Full Strength Acute Tryptophan Depletion
n=24 Participants
|
Half-Strength Tryptophan Depletion - Control
n=23 Participants
|
|---|---|---|
|
Serum Tryptophan Levels
|
0.0034 nmol/ml
Standard Deviation .0027
|
0.02 nmol/ml
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: One 24 hour monitoring session per week for 8 weeksPopulation: Subjects with completed hot flash data during both arms of study.
Mean of the 24 hour monitoring sessions for each patient based on one 24 hour monitoring session after each intervention using an electronic monitor.
Outcome measures
| Measure |
Full Strength Acute Tryptophan Depletion
n=27 Participants
|
Half-Strength Tryptophan Depletion - Control
n=27 Participants
|
|---|---|---|
|
Objective Subject Hot Flash Frequency
|
2.30 frequency of hot flashes
Standard Deviation 2.92
|
2.62 frequency of hot flashes
Standard Deviation 3.29
|
Adverse Events
Full Strength Acute Tryptophan Depletion
Half-Strength Tryptophan Depletion - Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place