Healthy, no Evidence of DiseasePhase 2SAMeNCT01140646
Evaluation of SAMe for Hot Flashes
A Phase 2 study testing S-adenosyl-L-methionine disulfate p-toluene-sulfonate, questionnaire administration and quality-of-life assessment in people with Healthy, no Evidence of Disease and Hot Flashes, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Healthy, no Evidence of Disease, Hot Flashes
- What is being tested?
- S-adenosyl-L-methionine disulfate p-toluene-sulfonate, questionnaire administration and quality-of-life assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes
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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Healthy, no Evidence of Disease, Hot Flashes
- Being tested
- S-adenosyl-L-methionine disulfate p-toluene-sulfonate, questionnaire administration, quality-of-life assessment
- Keywords
- Hot flashes, dietary supplements, symptom management
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-adenosyl-L-methionine disulfate p-toluene-sulfonateDrug
Also called SAMe disulfate p-toluene-sulfonate
Given orally
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | 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. Receives: Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 7
Secondary outcomes (4)
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.
Measured: Baseline and Week 7
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.
Measured: Baseline and Week 7
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.
Measured: Baseline and Week 7
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.
Measured: Week 1 to Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy, no Evidence of DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Sood, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140646
- Sponsor's protocol ID
- MC09C4
- Other IDs
- NCI-2010-01224, MC09C4, 10-001896
- Acronym
- SAMe
- Status last verified
- Jan 2019
- First submitted
- 8 Jun 2010
- Last updated
- 31 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes
- ClinicalTrials.gov ID
- NCT01140646
- Acronym / sponsor ID
- SAMe / MC09C4
- Conditions
- Healthy, no Evidence of Disease, Hot Flashes
- Keywords
- Hot flashes, dietary supplements, symptom management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Jun 2010 (estimated)
- Results
- Posted 11 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate, Other: questionnaire administration, Procedure: quality-of-life assessmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-adenosyl-L-methionine disulfate p-toluene-sulfonateAlso: SAMe disulfate p-toluene-sulfonateGiven orally | Drug | Arm I |
| questionnaire administrationAncillary studies | Other | Arm I |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I |
Primary outcome
Percent of Baseline in Average Hot Flash Activity (Score and Frequency)
Time frame: From baseline to week 7
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.
4 secondary outcomes
Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)
Time frame: Baseline and Week 7
Change From Baseline to Week 7 for the Profile of Mood States (POMS)
Time frame: Baseline and Week 7
Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame: Baseline and Week 7
Number of Patients Who Reported Grade 3 Adverse Events
Time frame: Week 1 to Week 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Sood, M.D. study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-adenosyl-L-methionine disulfate p-toluene-sulfonate, questionnaire administration and quality-of-life assessment in people with Healthy, no Evidence of Disease and Hot Flashes, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Baseline in Average Hot Flash Activity (Score and Frequency) (time frame: From baseline to week 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.