Evaluation of SAMe for Hot Flashes

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Healthy, no Evidence of Disease; Hot Flashes

Treatments: Other: questionnaire administration; Procedure: quality-of-life assessment; Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate

Study type: Interventional

Funder types: Other

Identifiers

NCT01140646

10-001896 (Other Identifier)

NCI-2010-01224 (Registry Identifier)

MC09C4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Arm I

Experimental group

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.

Treatment:

Other: questionnaire administration

Procedure: quality-of-life assessment

Drug: S-adenosyl-L-methionine disulfate p-toluene-sulfonate