Trial Outcomes & Findings for Evaluation of SAMe for Hot Flashes (NCT NCT01140646)
NCT ID: NCT01140646
Last Updated: 2019-01-31
Results Overview
Hot flash score was defined as the number of mild hot flashes for the week plus two times the number of moderate hot flashes plus three times the number of severe hot flashes plus four times the number of very severe hot flashes. Hot flash frequency was defined as the average number of hot flashes per day for each week. Week 7 percent of baseline was calculated. The reduction in hot flash score and frequency can be calculated by subtracting the week 7 percent of baseline from 100 percent.
COMPLETED
PHASE2
45 participants
From baseline to week 7
2019-01-31
Participant Flow
Forty-five (45) subjects were recruited between October 2010 and January 2012 at Mayo Clinic.
Two subjects were ineligible and excluded from all analyses except adverse events summary.
Participant milestones
| Measure |
SAMe
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
SAMe
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Refused Further Treatment
|
5
|
Baseline Characteristics
Evaluation of SAMe for Hot Flashes
Baseline characteristics by cohort
| Measure |
SAMe
n=43 Participants
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 6.5 • n=39 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=39 Participants
|
|
Tamoxifen Therapy
Yes
|
8 Participants
n=39 Participants
|
|
Tamoxifen Therapy
No
|
35 Participants
n=39 Participants
|
|
Raloxifene Therapy
Yes
|
0 Participants
n=39 Participants
|
|
Raloxifene Therapy
No
|
43 Participants
n=39 Participants
|
|
Aromatase Inhibitor Therapy
Yes
|
5 Participants
n=39 Participants
|
|
Aromatase Inhibitor Therapy
No
|
38 Participants
n=39 Participants
|
|
Average Hot Flashes per Day
2-3
|
3 Participants
n=39 Participants
|
|
Average Hot Flashes per Day
4-9
|
21 Participants
n=39 Participants
|
|
Average Hot Flashes per Day
>=10
|
19 Participants
n=39 Participants
|
|
Duration of Flash Symptoms (months)
<9 months
|
5 Participants
n=39 Participants
|
|
Duration of Flash Symptoms (months)
>=9 months
|
38 Participants
n=39 Participants
|
|
Breast Cancer History
Yes
|
18 Participants
n=39 Participants
|
|
Breast Cancer History
No
|
25 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 7Population: Analysis population includes only the subjects who have completed the quality of life self-assessment questionnaire.
Hot flash score was defined as the number of mild hot flashes for the week plus two times the number of moderate hot flashes plus three times the number of severe hot flashes plus four times the number of very severe hot flashes. Hot flash frequency was defined as the average number of hot flashes per day for each week. Week 7 percent of baseline was calculated. The reduction in hot flash score and frequency can be calculated by subtracting the week 7 percent of baseline from 100 percent.
Outcome measures
| Measure |
SAMe
n=31 Participants
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Percent of Baseline in Average Hot Flash Activity (Score and Frequency)
Week 7 percent of baseline for Hot Flash Score
|
64.6 Percent of baseline
Interval 49.2 to 80.0
|
|
Percent of Baseline in Average Hot Flash Activity (Score and Frequency)
Week 7 percent of baseline for Hot flash frequency
|
67.4 Percent of baseline
Interval 52.3 to 82.5
|
SECONDARY outcome
Timeframe: Baseline and Week 7Population: Includes all participants who initiated the study treatment.
The side effect questionnaire (SEQ) consists of 15 items on a scale of 0 to 10 with 10 represents worse symptoms. Each item were reported as individual scores with all scores transposed to a 0-100 point percentage scale where 100 is the best quality of life (QOL) scores. Change from baseline to week 7 scores was calculated by subtracting the baseline scores from the scores at week 7. The positive change in scores indicates an improvement in QOL and negative change in scores indicates a decline in QOL.
Outcome measures
| Measure |
SAMe
n=43 Participants
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Abnormal sweating
|
25 score on a scale
Standard Deviation 34.5
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Trouble sleeping
|
17.5 score on a scale
Standard Deviation 30.7
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Fatigue
|
11.7 score on a scale
Standard Deviation 25.2
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Muscle or joint aches/pain
|
10 score on a scale
Standard Deviation 20.6
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Trouble concentrating
|
7.5 score on a scale
Standard Deviation 20.2
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Swelling of hands/feet
|
2.8 score on a scale
Standard Deviation 18.9
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Anxiousness
|
2.8 score on a scale
Standard Deviation 16.7
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Constipation
|
2.5 score on a scale
Standard Deviation 25
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Diarrhea
|
1.4 score on a scale
Standard Deviation 18.3
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Headache
|
0 score on a scale
Standard Deviation 16
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Nausea
|
-1.4 score on a scale
Standard Deviation 18.1
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Lack of coordination
|
-3.8 score on a scale
Standard Deviation 14.8
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Appetite
|
-4.1 score on a scale
Standard Deviation 17.8
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Dry mouth
|
-4.1 score on a scale
Standard Deviation 22.4
|
|
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Sleepiness
|
-15.5 score on a scale
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: Baseline and Week 7Population: Includes all participants who initiated the study treatment.
The Profile of Mood States (POMS) consists of 30 items on scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The POMS was scored according to its specific scoring algorithm resulting in a total score and six subscale scores (anger/hostility, confusion/bewilderment, depression/dejection, fatigue/inertia, tension/anxiety, and vigor/activity). All scores were transposed to a 0-100 point percentage scale where 100 is the best quality of life (QOL) scores. Change from baseline to week 7 scores was calculated by subtracting the baseline scores from the scores at week 7. The positive change in scores indicates an improvement in QOL and negative change in scores indicates a decline in QOL.
Outcome measures
| Measure |
SAMe
n=43 Participants
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
POMS total
|
3.0 score on a scale
Standard Deviation 7.8
|
|
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Fatigue/inertia
|
10.9 score on a scale
Standard Deviation 18.7
|
|
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Anger/hostility
|
2.8 score on a scale
Standard Deviation 10.1
|
|
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Tension/anxiety
|
2.3 score on a scale
Standard Deviation 10.8
|
|
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Confusion/bewilderment
|
1.2 score on a scale
Standard Deviation 10.6
|
|
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Depression/dejection
|
0.7 score on a scale
Standard Deviation 8.8
|
|
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Vigor/activity
|
0.5 score on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Baseline and Week 7Population: Includes all participants who initiated the study treatment.
The Hot Flash Related Daily Interference Scale (HFRDIS) consists of 10 items on scale of 0 to 10 with 0 represents do not interfere and 10 represents completely interferes. An average of the scores of the 10 individual items was calculated for the HFRDIS total score. Each individual item were reported as individual scores. All scores were transposed to a 0-100 point percentage scale where 100 is the best quality of life (QOL) scores. Change from baseline to week 7 scores was calculated by subtracting the baseline scores from the scores at week 7. The positive change in scores indicates an improvement in QOL and negative change in scores indicates a decline in QOL.
Outcome measures
| Measure |
SAMe
n=43 Participants
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
HFRDIS total
|
8.6 score on a scale
Standard Deviation 14.4
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Mood
|
13.9 score on a scale
Standard Deviation 16.3
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Sleep
|
21.6 score on a scale
Standard Deviation 30.0
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Concentration
|
12.8 score on a scale
Standard Deviation 21.3
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Overall QOL
|
7.8 score on a scale
Standard Deviation 21.1
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Enjoyment of life
|
5.9 score on a scale
Standard Deviation 17.4
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Social activities
|
5.3 score on a scale
Standard Deviation 17.0
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Leisure activities
|
4.7 score on a scale
Standard Deviation 15.2
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Work
|
4.4 score on a scale
Standard Deviation 19.3
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Relationships with others
|
3.4 score on a scale
Standard Deviation 15.6
|
|
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Sexuality
|
2.8 score on a scale
Standard Deviation 23.7
|
SECONDARY outcome
Timeframe: Week 1 to Week 7Population: All participants who enrolled to the trial.
Adverse events were assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Outcome measures
| Measure |
SAMe
n=45 Participants
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Number of Patients Who Reported Grade 3 Adverse Events
Insomnia
|
2 Participants
|
|
Number of Patients Who Reported Grade 3 Adverse Events
Neoplasms: benign, malignant, unspecified
|
1 Participants
|
Adverse Events
SAMe
Serious adverse events
| Measure |
SAMe
n=45 participants at risk
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Psychiatric disorders
Insomnia
|
4.4%
2/45 • Number of events 2
All participants who enrolled to the trial.
|
Other adverse events
| Measure |
SAMe
n=45 participants at risk
The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
5/45 • Number of events 7
All participants who enrolled to the trial.
|
|
Gastrointestinal disorders
Bloating
|
51.1%
23/45 • Number of events 76
All participants who enrolled to the trial.
|
|
Gastrointestinal disorders
Diarrhea
|
24.4%
11/45 • Number of events 26
All participants who enrolled to the trial.
|
|
Gastrointestinal disorders
Nausea
|
35.6%
16/45 • Number of events 28
All participants who enrolled to the trial.
|
|
Gastrointestinal disorders
Stomach pain
|
2.2%
1/45 • Number of events 1
All participants who enrolled to the trial.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/45 • Number of events 1
All participants who enrolled to the trial.
|
|
General disorders
Fatigue
|
2.2%
1/45 • Number of events 2
All participants who enrolled to the trial.
|
|
Immune system disorders
Allergic reaction
|
6.7%
3/45 • Number of events 3
All participants who enrolled to the trial.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
1/45 • Number of events 2
All participants who enrolled to the trial.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • Number of events 1
All participants who enrolled to the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.2%
1/45 • Number of events 1
All participants who enrolled to the trial.
|
|
Nervous system disorders
Headache
|
6.7%
3/45 • Number of events 4
All participants who enrolled to the trial.
|
|
Psychiatric disorders
Insomnia
|
80.0%
36/45 • Number of events 143
All participants who enrolled to the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place