Evaluation of SAMe for Hot Flashes

NCT01140646 | Completed Phase 2 Results DMC

• 3 other identifiers: MC09C4NCI-2010-0122410-001896
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy, no Evidence of Disease; Hot Flashes

Keywords

Hot flashes, dietary supplements, symptom management

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to week 7

Secondary Outcomes (4)

• Change From Baseline to Week 7 for the Side Effect Questionnaire (SEQ)

  Baseline and Week 7

• Change From Baseline to Week 7 for the Profile of Mood States (POMS)

  Baseline and Week 7

• Change From Baseline to Week 7 for the Hot Flash Related Daily Interference Scale (HFRDIS)

  Baseline and Week 7

• Number of Patients Who Reported Grade 3 Adverse Events

  Week 1 to Week 7

Study Arms (1)

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.

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

Interventions

S-adenosyl-L-methionine disulfate p-toluene-sulfonate DRUG

Given orally

Also known as: SAMe disulfate p-toluene-sulfonate

Arm I

questionnaire administration OTHER

Ancillary studies

Arm I

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Amit Sood
• Organization: Mayo Clinic

sood.amit@mayo.edu

507-284-1623

Study Officials

• Amit Sood, M.D.

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 9, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 31, 2019
• Results First Posted: April 11, 2014

Record last verified: 2019-01

Locations

US (1)