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Evaluation of SAMe for Hot Flashes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01140646
First received: June 8, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy, no Evidence of Disease
Hot Flashes
 Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate
Other: questionnaire administration
Procedure: quality-of-life assessment
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of S-Adenosyl-L-Methionine (SAMe) for the Treatment of Hot Flashes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Reduction in average hot flash activity score (severity and frequency) [ Time Frame: From baseline to week 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in self-assessment items [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Adverse event grade incidence [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: October 2010
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
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.
 Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate
Given orally
Other Name: SAMe disulfate p-toluene-sulfonate
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140646

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Amit Sood, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Amit Sood, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT01140646     History of Changes
Other Study ID Numbers: MC09C4, NCI-2010-01224, MC09C4, 10-001896
Study First Received: June 8, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Hot flashes, dietary supplements, symptom management

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013