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Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen


Phase 2
20 Years
N/A
Not Enrolling
Female
Breast Cancer, Hot Flashes

Thank you

Trial Information

Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen


OBJECTIVES:

- Compare the effect of soy protein vs placebo on the daily number and severity of hot
flashes in postmenopausal women with breast disease taking tamoxifen.

- Compare the quality of life in patients treated with these regimens.

- Compare the time to first relief of hot flashes in patients treated with these
regimens.

- Compare the effect of these regimens on hormonal change in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to duration of hot flashes (less than 9 months vs 9 months or more)
and frequency of hot flashes (7 to 9 per day vs more than 9 per day).

Patients receive oral placebo once per day and keep a hot flash diary daily for 1 week and
are then randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral soy supplement once daily for 12 weeks.

- Arm II: Patients receive oral placebo once daily for 12 weeks. Patients on both arms
complete a daily hot flash diary.

Quality of life is assessed at baseline and at weeks 6 and 12.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 130 patients (65 per treatment arm) will be accrued for this
study within 9 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed breast disease, including one of the following:

- Atypical ductal hyperplasia

- Ductal carcinoma in situ

- Lobular carcinoma in situ

- Stage I, II, or IIIA invasive adenocarcinoma

- Must be taking tamoxifen on a daily basis

- Bothersome hot flashes, at least 7 per day for at least 1 month and severe enough to
make patient desire intervention

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 20 and over

Sex:

- Female

Menopausal status:

- Postmenopausal, defined by one of the following:

- Surgical menopause

- At least 1 year since prior menses

- Postmenopausal FSH levels

Performance status:

- CALGB 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No prior soy or milk intolerance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Prior adjuvant chemotherapy allowed

- No concurrent adjuvant chemotherapy

Endocrine therapy:

- See Disease Characteristics

- At least 4 weeks since prior progestational therapy

- No concurrent progestins (e.g., megestrol)

- No concurrent systemic hormone replacement therapy or vaginal estrogen creams

- Estradiol-releasing vaginal ring allowed

Radiotherapy:

- Prior radiotherapy allowed

- No concurrent radiotherapy

Surgery:

- Prior surgery allowed

- No concurrent surgery

Other:

- At least 4 weeks since prior vitamin E, clonidine, belladonna derivative, or soy
supplement for hot flashes

- At least 4 weeks since prior selective serotonin reuptake inhibitors for hot flashes

- Concurrent antidepressants allowed provided dose has been stable for at least 1 month
and the purpose is for other than control of hot flashes

- No concurrent vitamin E, clonidine, belladonna derivative, or other soy supplement
for hot flashes

- Concurrent low doses of vitamin E that are part of a multivitamin allowed

- No other concurrent soy products

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Outcome Measure:

Change in number of daily hot flashes at 3 months from baseline

Principal Investigator

Gini F. Fleming, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

CDR0000069219

NCT ID:

NCT00031720

Start Date:

March 2002

Completion Date:

April 2006

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • lobular breast carcinoma in situ
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • ductal breast carcinoma in situ
  • hot flashes
  • Breast Neoplasms
  • Hot Flashes

Name

Location

Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Kinston Medical SpecialistsKinston, North Carolina  28501
Center for Cancer Care at OSF Saint Anthony Medical CenterRockford, Illinois  61108
Commonwealth Hematology-Oncology, PC - WorcesterWorcester, Massachusetts  01605