11 Psychosocial Issues, Quality of Life, Lifestyle

11.1 Diet and Estrogen Metabolism in Postmenopausal Women

Objectives

Determine the effect of a low-fat diet combined with either high fiber (25-35 grams per day) or low fiber (10-15 grams per day) intake on estrogen metabolism in healthy postmenopausal women.

Participation Criteria

• Healthy postmenopausal female between the ages of 50 and 69 with diet of greater than 32% of total calories from fat and less than 15 grams of fiber.
• No concurrent medication that can interfere with blood test results.
• No hormone replacement therapy or thyroid hormones.
• At least 2 years since menopause.
• Increased body fat (125%-175% of ideal body weight).
• Increased upper body fat (waist-to-hip circumference ratio greater than 0.85).
• Serum estradiol greater than 13 picograms per milliliter.

Randomization

All patients must successfully complete a dietary
run-in phase for 4 weeks before randomization. During the run-in phase, patients are asked to maintain a food record for days 7-14. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 14, 21, and 28.

Patients are given 3 prepackaged meals a day for 12 weeks. Patients must maintain a record of all food eaten and return all food containers to the center for documentation. Patients undergo radioisotopic infusion study of sex steroid metabolism on days 70, 77, and 84. At the end of the 12 weeks, patients meet with the dietitian for 30 minutes to receive instructions on maintaining a low-fat, high fiber diet for the second phase of the study.

David Heber, Chair Principal Investigator
Ph: 310-206-1987 Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California

11.2 Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy

Objectives

I. Evaluate the relative contributions of factors that may lead to weight gain in breast cancer patients receiving adjuvant chemotherapy. Factors examined include:

• Hormonal and growth factor status (follicle stimulating hormone; total, bound, and free estradiol; androgens; sex hormone binding globulin; thyroid hormones; prolactin; insulin-like growth factors I and II; and plasma leptin).
• Factors affecting energy intake or expenditure (oral intake, physical activity, and resting metabolic rate).
• Psychological factors (depression and quality of life).

II. Evaluate the effect of chemotherapy on hormonal and growth factor status in these patients.
III. Assess the impact of chemotherapy on bone marrow density in these patients.

Participation Criteria

• Age: 18 to 80
• Menopausal status: Premenopausal or postmenopausal.
• Histologically proven newly diagnosed stage I, II, or resectable IIIA primary breast cancer.
• Scheduled to receive chemotherapy.
• No prior oophorectomy.

Protocol

Patients are monitored at baseline (4 weeks after surgery and before chemotherapy) and at 2 weeks and 6 months after completion of chemotherapy.

Patients complete various questionnaires (epidemiological risk factor, dietary assessment/ energy intake, physical activity, depression, and quality of life) at these time points. Other tests conducted at these time points include daily energy expenditure (measured by drinking doubly labeled water for one week), body composition (measured with dual energy x-ray absorptiometry), visceral and subcutaneous abdominal adipose tissue (measured by axial CT scans), and blood tests for hormone levels.

Noreen Aziz, Chair
Ph: 301-496-0598 Division of Clinical Sciences

Demetrius Albanes Principal Investigator
Ph: 301-496-8559 Cancer Prevention Studies Branch Bethesda, Maryland

11.3 Randomized Study of Methods in Education for Breast Cancer Genetics

Objectives

Compare the effect of two different methods of providing education to persons enrolling in a breast cancer genetics program.

Participation Criteria

• Diagnosis of breast cancer or ductal carcinoma in situ at age 45 or under
  OR
  Diagnosis of ovarian cancer at age 50 or under
  OR
  Diagnosis of breast cancer with bilateral disease or multiple primaries or breast cancer and ovarian cancer in the same individual
  OR
  Diagnosis of breast or ovarian cancer AND

• At least one first-or second-degree relative with breast cancer diagnosed at age 45 or under or ovarian cancer at age 50 or under
  OR
• Three relatives in the same lineage with breast or ovarian cancer where each affected individual is a first-or second- degree relative to another of the affected individuals
  OR
• First-or second-degree male relative with breast cancer diagnosed at any age
  OR

• Women of Ashkenazi Jewish descent who meet any of the above criteria with specified ages of onset of 50 for breast cancer and any age for ovarian cancer OR
• Male with breast cancer diagnosed at any age OR
• Documented BRCA mutation in the family

Protocol

Participants are randomized to one of two different education methods.

All participants complete a pre-test questionnaire, then attend a breast cancer genetics education and counseling session. A post-test questionnaire is also
completed.

Participants may then choose to undergo germline BRCA testing.

Participants are followed at 1 week and 3, 6, and 12 months after receiving results of BRCA germline testing.

Pamela Klein, Chair Principal Investigator
Ph: 301-295-3899 Division of Clinical Sciences, Medicine Branch Bethesda, Maryland

11.4 Randomized Study of Stress Reduction in Older Women with Stage II, III, or IV Breast Cancer

Objectives

I. Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival
time in older women with stage II, III, or IV breast cancer.

II. Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients.

III. Determine baseline variables that contribute to predicting survival time in these patients.

Participation Criteria

• Age: 55 and over.
• Menopausal status: Not specified.
• Hormone receptor status: Not specified.
• Diagnosis of stage II, III, or IV breast cancer.
• No brain or CNS metastases.

Randomization

Rhoda Pomerantz, Chair
Ph: 773-665-3606 St. Joseph Health Centers & Hospital