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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01224 | Registry Identifier | NCI's CTRO | |
| MC09C4 | Other Identifier | Mayo Clinic Cancer Center | |
| 10-001896 | Other Identifier | Mayo Clinic IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-adenosyl-L-methionine disulfate p-toluene-sulfonate | Drug | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amit Sood, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Two subjects were ineligible and excluded from all analyses except adverse events summary.
Forty-five (45) subjects were recruited between October 2010 and January 2012 at Mayo Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | SAMe | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SAMe | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis population includes only the subjects who have completed the quality of life self-assessment questionnaire. | Posted | Mean | 95% Confidence Interval | Percent of baseline | From baseline to week 7 |
|
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All participants who enrolled to the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAMe | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amit Sood | Mayo Clinic | 507-284-1623 | sood.amit@mayo.edu |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| questionnaire administration | Other | Ancillary studies |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| 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. | 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. | 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. | Week 1 to Week 7 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Tamoxifen Therapy | Number | Participants |
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| Raloxifene Therapy | Number | Participants |
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| Aromatase Inhibitor Therapy | Number | Participants |
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| Average Hot Flashes per Day | Number | Participants |
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| Duration of Flash Symptoms (months) | Number | Participants |
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| Breast Cancer History | Number | Participants |
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| Secondary | 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. | Includes all participants who initiated the study treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 7 |
|
|
|
| Secondary | 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. | Includes all participants who initiated the study treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 7 |
|
|
|
| Secondary | 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. | Includes all participants who initiated the study treatment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 7 |
|
|
|
| Secondary | 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. | All participants who enrolled to the trial. | Posted | Count of Participants | Participants | Week 1 to Week 7 |
|
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|
| 2 |
| 45 |
| 41 |
| 45 |
| Bloating | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
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| Allergic reaction | Immune system disorders | MedDRA 12 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
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| Fatigue |
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| Muscle or joint aches/pain |
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| Trouble concentrating |
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| Swelling of hands/feet |
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| Anxiousness |
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| Constipation |
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| Diarrhea |
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| Headache |
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| Nausea |
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| Lack of coordination |
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| Appetite |
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| Dry mouth |
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| Sleepiness |
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| Anger/hostility |
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| Tension/anxiety |
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| Confusion/bewilderment |
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| Depression/dejection |
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| Vigor/activity |
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| Sleep |
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| Concentration |
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| Overall QOL |
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| Enjoyment of life |
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| Social activities |
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| Leisure activities |
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| Work |
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| Relationships with others |
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| Sexuality |
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