Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Weight Loss Program for Overweight Women With Stage I or Stage II Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Behavioral study	Closed	pre- and postmenopausal	NCI	CLB-9371 NCI-P93-0052

Objectives

I.  Identify the short-term compliance rate of overweight women who have 
completed adjuvant chemotherapy for stage I/II breast cancer and are enrolled 
in a weight loss intervention program.

II.  Demonstrate the feasibility of conducting such a program in a cooperative 
group setting.

III.  Correlate the expected beneficial weight loss and circulating levels of 
hormones and sex hormone-binding globulin (SHBG).

IV.  Obtain data that will be used to design a comparative study investigating 
the effect of weight loss on survival.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Prior/Concurrent Therapy:

See Population Characteristics
Concurrent tamoxifen allowed

Patient Characteristics:

Age:
  Pre- and postmenopausal

Sex:
  Women only

Performance status:
  0 or 1

Hematopoietic:
  Not specified

Hepatic:
  No previous history of cirrhosis

Renal:
  Not specified

Other:
  No requirement for steroids (including androgens, corticosteroids, megestrol
     acetate)
  No requirement for cholesterol-lowering therapeutic regimens
  No more than 10% weight loss 3 months prior to beginning weight loss program
  No existing medical condition that would preclude participation in a weight
     reduction and exercise program
  Must have reasonable proximity to a Weight Watchers facility

General Eligibility Criteria:

--Population Characteristics--

Women diagnosed with and treated for stage I/II adenocarcinoma of the breast
and considered overweight
  More than 10% over ideal body weight using Weight Watchers Goal-Weight Table

Completion of chemotherapy in a CALGB adjuvant study with full recovery from
toxicity required

Prior surgery may have included radical or modified radical mastectomy, or
breast-sparing procedure plus axillary dissection
  At least a level I and II axillary dissection required

Patients must consult with and receive approval from their physician prior to
beginning weight loss and exercise program

--Prior/Concurrent Therapy--

See Population Characteristics
Concurrent tamoxifen allowed

--Patient Characteristics--

Age:
  Pre- and postmenopausal

Sex:
  Women only

Performance status:
  0 or 1

Hematopoietic:
  Not specified

Hepatic:
  No previous history of cirrhosis

Renal:
  Not specified

Other:
  No requirement for steroids (including androgens, corticosteroids, megestrol
     acetate)
  No requirement for cholesterol-lowering therapeutic regimens
  No more than 10% weight loss 3 months prior to beginning weight loss program
  No existing medical condition that would preclude participation in a weight
     reduction and exercise program
  Must have reasonable proximity to a Weight Watchers facility

Expected Enrollment

A total of 150 women (75 premenopausal and 75 postmenopausal) will be entered.

Outline

Patients are stratified by menopausal status.

Patients who have completed and recovered from the toxic effects of adjuvant 
chemotherapy join a Weight Watchers (WW) program that includes a 6-week 
maintenance plan once the weight goal is achieved.  Participation in the 
program lasts for up to 1 year.

Concurrent steroids and cholesterol-lowering regimens are not allowed.

Patients are followed every 4 months for relapse and survival.  Blood levels 
of hormones, sex hormone-binding globulin, triglycerides, and lipids are 
obtained prior to entering and upon completion of the program, and upon 
relapse.

Trial Contact Information

Trial Lead Organizations

Cancer and Leukemia Group B

Consuelo Skosey, RN, Protocol chair		Ph: 312-702-0454; 888-824-0200

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