Back to resultsEvaluation of SAMe for Hot Flashes (SAMe)
Primary Purpose
Healthy, no Evidence of Disease, Hot Flashes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
S-adenosyl-L-methionine disulfate p-toluene-sulfonate
questionnaire administration
quality-of-life assessment
Sponsored by
About this trial
This is an interventional treatment trial for Healthy, no Evidence of Disease focused on measuring Hot flashes, dietary supplements, symptom management
Eligibility Criteria
Inclusion Criteria:
- Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer
- Bothersome hot flashes (defined by their occurrence >= 14 times per week and of sufficient severity to make the patient desire therapeutic intervention)
- Presence of hot flashes for >= 1 month prior to registration
- Life expectancy >= 6 months
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Ability to complete questionnaire(s) by themselves or with assistance
- Negative pregnancy test done =< 7 days prior to registration for women of childbearing potential only
Exclusion Criteria:
- Any of the following current (=< last 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for >= 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy, vitamin E, flaxseed, and megadose vitamins (herbal teas, multivitamins, and vitamin D are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency), medications interacting with SAMe (antidepressants, monoamine oxidase (MAO) inhibitors, meperidine, dextromethorphan, pentazocine, tramadol, gabapentin, and levodopa)
- Pregnant women
- Nursing women
- Women of childbearing potential who are unwilling to employ adequate contraception
- Known allergy to SAMe
- Current use or use within the past 6 months of SAMe
- Clinically significant acute or chronic progressive or unstable neurologic, psychiatric, hepatic, renal, cardiovascular, respiratory, metabolic, or systemic disease precluding participation in the study
- History of bipolar disorder or Parkinsonism
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm I
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent of Baseline in Average Hot Flash Activity (Score and Frequency)
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.
Secondary Outcome Measures
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
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.
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
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.
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
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.
Number of Patients Who Reported Grade 3 Adverse Events
Adverse events were assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01140646
Brief Title
Evaluation of SAMe for Hot Flashes
Acronym
SAMe
Official Title
Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its ability to potentially modulate serotonin.
PURPOSE: This phase II trial is studying the side effects and how well s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast cancer or those who do not wish to take estrogen due to a perceived increased risk of breast cancer.
Detailed Description
OBJECTIVES:
I. To evaluate the impact of SAMe on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
II. To evaluate the toxicity of SAMe in this study population. III. To evaluate the effect of SAMe using quality-of-life (QOL) measures.
OUTLINE:
During the first week, participants will complete a daily, prospective hot flash diary and complete baseline questionnaires and will not be taking any study medication. After this baseline week, participants will 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, no Evidence of Disease, Hot Flashes
Keywords
Hot flashes, dietary supplements, symptom management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-adenosyl-L-methionine disulfate p-toluene-sulfonate
Other Intervention Name(s)
SAMe disulfate p-toluene-sulfonate
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Percent of Baseline in Average Hot Flash Activity (Score and Frequency)
Description
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.
Time Frame
From baseline to week 7
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Description
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.
Time Frame
Baseline and Week 7
Title
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Description
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.
Time Frame
Baseline and Week 7
Title
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Description
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.
Time Frame
Baseline and Week 7
Title
Number of Patients Who Reported Grade 3 Adverse Events
Description
Adverse events were assessed per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time Frame
Week 1 to Week 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer
Bothersome hot flashes (defined by their occurrence >= 14 times per week and of sufficient severity to make the patient desire therapeutic intervention)
Presence of hot flashes for >= 1 month prior to registration
Life expectancy >= 6 months
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Ability to complete questionnaire(s) by themselves or with assistance
Negative pregnancy test done =< 7 days prior to registration for women of childbearing potential only
Exclusion Criteria:
Any of the following current (=< last 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for >= 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy, vitamin E, flaxseed, and megadose vitamins (herbal teas, multivitamins, and vitamin D are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency), medications interacting with SAMe (antidepressants, monoamine oxidase (MAO) inhibitors, meperidine, dextromethorphan, pentazocine, tramadol, gabapentin, and levodopa)
Pregnant women
Nursing women
Women of childbearing potential who are unwilling to employ adequate contraception
Known allergy to SAMe
Current use or use within the past 6 months of SAMe
Clinically significant acute or chronic progressive or unstable neurologic, psychiatric, hepatic, renal, cardiovascular, respiratory, metabolic, or systemic disease precluding participation in the study
History of bipolar disorder or Parkinsonism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Sood, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Evaluation of SAMe for Hot Flashes
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