Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Dietary Intervention in Women Who Have Been Treated For Stage I, Stage II, or Stage III Breast Cancer: Women's Healthy Eating and Living (WHEL) Study

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention, Treatment Closed 18 to 70 at time of diagnosis NCI UCSD-980919 UCSD-WHEL, NCI-G99-1508, NCT00003787

Objectives

I.  Determine whether a diet rich in vegetables, fruit, and fiber and low in 
fat is associated with a longer breast cancer event-free interval in breast 
cancer survivors.

II.  Motivate an intervention group of breast cancer survivors to adopt and 
maintain a dietary pattern that is rich in vegetables, fruit, and fiber and 
low in fat.

III.  Demonstrate that the intervention can produce significant changes in 
circulating carotenoid and estrogen biomarkers compared to a healthy control 
diet.

IV.  Test whether the probability of a secondary cancer event is associated 
with change in self-reported dietary intake, circulating carotenoid 
concentrations, and circulating estrogen concentrations.

Entry Criteria

Disease Characteristics:

Primary operable stage I (tumors at least 1 cm), stage II, and stage IIIA
invasive breast carcinoma

Treatment within the past 4 years by total mastectomy and axillary dissection,
or breast sparing surgical removal of cancer with clear macroscopic margins
and axillary dissection followed by adjuvant breast radiation

No evidence of recurrent disease or new breast cancer since completion of
initial local treatment confirmed within the past 6 months by physician
evaluation, except stage I mastectomy, for which physician evaluation can be
within 1 year prior to randomization

Hormone receptor status:
 Not specified

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No concurrent chemotherapy

Endocrine therapy:
 No concurrent estrogen replacement therapy, including vaginal estrogen
  creams   

Radiotherapy:
 See Disease Characteristics

Surgery:
 See Disease Characteristics

Other:
 No concurrent enrollment in another clinical trial that has dietary
  restrictions or endpoints similar to this study

Patient Characteristics:

Age:
 18 to 70 at time of diagnosis

Sex:
 Female

Menopausal status:
 Not specified

Performance status:
 Not specified

Life expectancy:
 At least 10 years (excluding breast cancer)

Hematopoietic:
 Not specified

Hepatic:
 No cirrhosis

Renal:
 Not specified   

Other:
 Not pregnant
 Accessible geographically and by telephone
 Able to communicate dietary data via 24-hour food recall
 Able to commit to the intervention schedule
 No comorbidity requiring a specific diet or taking a medication which
  contraindicates consuming a high fiber diet (e.g., systemic scleroderma,
  other digestive malabsorption syndromes, and insulin dependent diabetes)
 No other primary or recurrent invasive cancer within the past 10 years except
  nonmelanoma skin cancer or carcinoma in situ of the cervix

Expected Enrollment

A total of 3,000 women will be accrued for this study within 5 years.

Outline

This is a randomized, multicenter study.  Patients are stratified according to 
age (under 55 vs 55 and over at time of diagnosis), stage of tumor (stage I 
and at least 1 cm vs stage II/IIIA), and clinical site.

Patients are randomized to one of two healthy dietary regimens:

Arm I:  Patients are taught to follow a dietary pattern that will produce 
significant changes in circulating carotenoid and estrogen biomarkers.

Arm II:  Patients are assigned to follow dietary guidelines established by the 
National Cancer Institute and the USDA.  

All patients participate in 24 hour dietary recalls, cooking classes, as well 
as complete several questionnaires, at baseline and then at 12, 24 or 36, 48, 
and 72 months; a randomly selected 50% sample participate in recall at 6 
months.

Patients are followed by telephone every 6 months for an average of 6 years.

Hernández-Valero MA, Thomson CA, Hernández M, et al.: Comparison of baseline dietary intake of Hispanic and matched non-Hispanic white breast cancer survivors enrolled in the Women's Healthy Eating and Living study. J Am Diet Assoc 108 (8): 1323-9, 2008.[PUBMED Abstract]

Mortimer JE, Flatt SW, Parker BA, et al.: Tamoxifen, hot flashes and recurrence in breast cancer. Breast Cancer Res Treat 108 (3): 421-6, 2008.[PUBMED Abstract]

Hong S, Bardwell WA, Natarajan L, et al.: Correlates of physical activity level in breast cancer survivors participating in the Women's Healthy Eating and Living (WHEL) Study. Breast Cancer Res Treat 101 (2): 225-32, 2007.[PUBMED Abstract]

Parker BA, Flatt SW, Mortimer JA, et al.: Impact of hormone replacement therapy on breast cancer: Women's Healthy Eating and Living (WHEL) study experience. [Abstract] Breast Cancer Res Treat 106 (1): A-1055, S59, 2007.

Pierce JP, Natarajan L, Caan BJ, et al.: Influence of a diet very high in vegetables, fruit, and fiber and low in fat on prognosis following treatment for breast cancer: the Women's Healthy Eating and Living (WHEL) randomized trial. JAMA 298 (3): 289-98, 2007.[PUBMED Abstract]

Pierce JP, Natarajan L, Cann BJ, et al.: The influence of a very high vegetable-fruit-fiber, low-fat diet on prognosis following treatment for breast cancer: results from the Womens Healthy Eating and Living (WHEL) randomized trial. [Abstract] Breast Cancer Res Treat 106 (1): A-61, S16, 2007.

Pierce JP, Stefanick ML, Flatt SW, et al.: Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol 25 (17): 2345-51, 2007.[PUBMED Abstract]

Saquib N, Flatt SW, Natarajan L, et al.: Weight gain and recovery of pre-cancer weight after breast cancer treatments: evidence from the women's healthy eating and living (WHEL) study. Breast Cancer Res Treat 105 (2): 177-86, 2007.[PUBMED Abstract]

Bardwell WA, Natarajan L, Dimsdale JE, et al.: Objective cancer-related variables are not associated with depressive symptoms in women treated for early-stage breast cancer. J Clin Oncol 24 (16): 2420-7, 2006.[PUBMED Abstract]

Madlensky L, Flatt SW, Bardwell WA, et al.: Is family history related to preventive health behaviors and medical management in breast cancer patients? Breast Cancer Res Treat 90 (1): 47-54, 2005.[PUBMED Abstract]

Newman VA, Thomson CA, Rock CL, et al.: Achieving substantial changes in eating behavior among women previously treated for breast cancer--an overview of the intervention. J Am Diet Assoc 105 (3): 382-91; quiz 488, 2005.[PUBMED Abstract]

Thomson CA, Giuliano AR, Shaw JW, et al.: Diet and biomarkers of oxidative damage in women previously treated for breast cancer. Nutr Cancer 51 (2): 146-54, 2005.[PUBMED Abstract]

Thornton AA, Madlensky L, Flatt SW, et al.: The impact of a second breast cancer diagnosis on health related quality of life. Breast Cancer Res Treat 92 (1): 25-33, 2005.[PUBMED Abstract]

Pierce JP, Newman VA, Flatt SW, et al.: Telephone counseling intervention increases intakes of micronutrient- and phytochemical-rich vegetables, fruit and fiber in breast cancer survivors. J Nutr 134 (2): 452-8, 2004.[PUBMED Abstract]

Rock CL, Flatt SW, Thomson CA, et al.: Plasma triacylglycerol and HDL cholesterol concentrations confirm self-reported changes in carbohydrate and fat intakes in women in a diet intervention trial. J Nutr 134 (2): 342-7, 2004.[PUBMED Abstract]

Wasserman L, Flatt SW, Natarajan L, et al.: Correlates of obesity in postmenopausal women with breast cancer: comparison of genetic, demographic, disease-related, life history and dietary factors. Int J Obes Relat Metab Disord 28 (1): 49-56, 2004.[PUBMED Abstract]

Gold EB, Flatt SW, Pierce JP, et al.: Dietary factors and vasomotor symptoms in breast cancer survivors: the WHEL Study. Menopause 13 (3): 423-33, 2006 May-Jun.[PUBMED Abstract]

Pierce JP, Faerber S, Wright FA, et al.: A randomized trial of the effect of a plant-based dietary pattern on additional breast cancer events and survival: the Women's Healthy Eating and Living (WHEL) Study. Control Clin Trials 23 (6): 728-56, 2002.[PUBMED Abstract]

Yost KJ, Haan MN, Levine RA, et al.: Comparing SF-36 scores across three groups of women with different health profiles. Qual Life Res 14 (5): 1251-61, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Rebecca and John Moores UCSD Cancer Center

John P. Pierce, PhD, Protocol chair		Ph: 858-822-5354

Registry Information
Official Title		Women's Healthy Eating and Living Study
Trial Start Date		1995-03-15
Registered in ClinicalTrials.gov		NCT00003787
Date Submitted to PDQ		1999-02-23
Information Last Verified		2006-07-28
NCI Grant/Contract Number		CA69375