TriangleNCT00003787 · CITED IN SOURCE DOCUMENTS
Women's Healthy Eating and Living Study
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- Not reported
- Status at capture
- COMPLETED
- Registry last update
- 2019-06-10
RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer recurrence. PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage II, or stage III breast cancer.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility 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 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 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
- healthy Volunteers
- false
- maximum Age
- 70 Years
- minimum Age
- 18 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Women who were diagnosed with early-stage breast cancer within the previous 4 years, and are between the ages of 18-74
Treatment arms and interventions
- arm Groups
- description
- high fiber, high vegetable, low-fat diet
- intervention Names
- Behavioral: educational/counseling intervention
- Behavioral: therapeutic dietary intervention
- label
- Intervention
- description
- NCI-recommended diet
- intervention Names
- Behavioral: therapeutic dietary intervention
- label
- Control
- interventions
- arm Group Labels
- Intervention
- name
- educational/counseling intervention
- type
- BEHAVIORAL
- arm Group Labels
- Control
- Intervention
- name
- therapeutic dietary intervention
- type
- BEHAVIORAL
Study design
- observational Model
- CASE_CONTROL
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 3088
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Breast Cancer Recurrence
- time Frame
- Lifetime
- secondary Outcomes
- measure
- Mortality
- time Frame
- Lifetime
Full study description
- brief Summary
- RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer recurrence. PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage II, or stage III breast cancer.
- detailed Description
- 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. 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. PROJECTED ACCRUAL: A total of 3,000 women will be accrued for this study within 5 years.
Source references
- references
- citation
- Hyder JA, Thomson CA, Natarajan L, Madlensky L, Pu M, Emond J, Kealey S, Rock CL, Flatt SW, Pierce JP; WHEL Study Group. Adopting a plant-based diet minimally increased food costs in WHEL Study. Am J Health Behav. 2009 Sep-Oct;33(5):530-9. doi: 10.5993/ajhb.33.5.6.
- pmid
- 19296743
- type
- BACKGROUND
- citation
- Yost KJ, Haan MN, Levine RA, Gold EB. Comparing SF-36 scores across three groups of women with different health profiles. Qual Life Res. 2005 Jun;14(5):1251-61. doi: 10.1007/s11136-004-6673-8.
- pmid
- 16047501
- type
- BACKGROUND
- citation
- Caan BJ, Emond JA, Su HI, Patterson RE, Flatt SW, Gold EB, Newman VA, Rock CL, Thomson CA, Pierce JP. Effect of postdiagnosis weight change on hot flash status among early-stage breast cancer survivors. J Clin Oncol. 2012 May 1;30(13):1492-7. doi: 10.1200/JCO.2011.36.8597. Epub 2012 Mar 19.
- pmid
- 22430275
- type
- RESULT
- citation
- Nechuta SJ, Caan BJ, Chen WY, Lu W, Chen Z, Kwan ML, Flatt SW, Zheng Y, Zheng W, Pierce JP, Shu XO. Soy food intake after diagnosis of breast cancer and survival: an in-depth analysis of combined evidence from cohort studies of US and Chinese women. Am J Clin Nutr. 2012 Jul;96(1):123-32. doi: 10.3945/ajcn.112.035972. Epub 2012 May 30.
- pmid
- 22648714
- type
- RESULT
- citation
- Al-Delaimy WK, Flatt SW, Natarajan L, Laughlin GA, Rock CL, Gold EB, Caan BJ, Parker BA, Pierce JP. IGF1 and risk of additional breast cancer in the WHEL study. Endocr Relat Cancer. 2011 Mar 3;18(2):235-44. doi: 10.1530/ERC-10-0121. Print 2011 Apr.
- pmid
- 21263044
- type
- RESULT
- citation
- Bertram LA, Stefanick ML, Saquib N, Natarajan L, Patterson RE, Bardwell W, Flatt SW, Newman VA, Rock CL, Thomson CA, Pierce JP. Physical activity, additional breast cancer events, and mortality among early-stage breast cancer survivors: findings from the WHEL Study. Cancer Causes Control. 2011 Mar;22(3):427-35. doi: 10.1007/s10552-010-9714-3. Epub 2010 Dec 24.
- pmid
- 21184262
- type
- RESULT
- citation
- Emond JA, Patterson RE, Natarajan L, Laughlin GA, Gold EB, Pierce JP. Sex hormone concentrations and the risk of breast cancer recurrence in postmenopausal women without hot flashes. Cancer Epidemiol Biomarkers Prev. 2011 May;20(5):939-45. doi: 10.1158/1055-9965.EPI-10-1240. Epub 2011 Mar 17.
- pmid
- 21415358
- type
- RESULT
- citation
- Jacobs ET, Thomson CA, Flatt SW, Al-Delaimy WK, Hibler EA, Jones LA, Leroy EC, Newman VA, Parker BA, Rock CL, Pierce JP. Vitamin D and breast cancer recurrence in the Women's Healthy Eating and Living (WHEL) Study. Am J Clin Nutr. 2011 Jan;93(1):108-17. doi: 10.3945/ajcn.2010.30009. Epub 2010 Oct 27.
- pmid
- 20980485
- type
- RESULT
- citation
- Madlensky L, Natarajan L, Tchu S, Pu M, Mortimer J, Flatt SW, Nikoloff DM, Hillman G, Fontecha MR, Lawrence HJ, Parker BA, Wu AH, Pierce JP. Tamoxifen metabolite concentrations, CYP2D6 genotype, and breast cancer outcomes. Clin Pharmacol Ther. 2011 May;89(5):718-25. doi: 10.1038/clpt.2011.32. Epub 2011 Mar 23.
- pmid
- 21430657
- type
- RESULT
- citation
- Paxton RJ, Jones LA, Chang S, Hernandez M, Hajek RA, Flatt SW, Natarajan L, Pierce JP. Was race a factor in the outcomes of the Women's Health Eating and Living Study? Cancer. 2011 Aug 15;117(16):3805-13. doi: 10.1002/cncr.25957. Epub 2011 Feb 11.
- pmid
- 21319157
- type
- RESULT
- citation
- Gold EB, Pierce JP, Natarajan L, Stefanick ML, Laughlin GA, Caan BJ, Flatt SW, Emond JA, Saquib N, Madlensky L, Kealey S, Wasserman L, Thomson CA, Rock CL, Parker BA, Karanja N, Jones V, Hajek RA, Pu M, Mortimer JE. Dietary pattern influences breast cancer prognosis in women without hot flashes: the women's healthy eating and living trial. J Clin Oncol. 2009 Jan 20;27(3):352-9. doi: 10.1200/JCO.2008.16.1067. Epub 2008 Dec 15.
- pmid
- 19075284
- type
- RESULT
- citation
- Pierce JP, Natarajan L, Caan BJ, Flatt SW, Kealey S, Gold EB, Hajek RA, Newman VA, Rock CL, Pu M, Saquib N, Stefanick ML, Thomson CA, Parker B. Dietary change and reduced breast cancer events among women without hot flashes after treatment of early-stage breast cancer: subgroup analysis of the Women's Healthy Eating and Living Study. Am J Clin Nutr. 2009 May;89(5):1565S-1571S. doi: 10.3945/ajcn.2009.26736F. Epub 2009 Apr 1.
- pmid
- 19339393
- type
- RESULT
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-13850afff124451e1f42
- requested nct id
- NCT00003787
- primary nct id
- NCT00003787
- source kind
- fda_spl_label
- source record id
- 5bcbc281-342c-4b05-8409-53a08b1fc9f6
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- payload sha256
- 946e008769e958a521f596a8d574e1a1768b0fbb408adb325ea29c6f81a97abf
- payload
- application numbers
- NDA021807
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-13850afff124451e1f42
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00003787
- occurrences
- context exact
- ional alleles of CYP2D6. In patients with estrogen receptor-positive breast cancer who were participating in the WHEL (Women's Health Eating and Living) Study (NCT00003787), the mean (SD) serum concentration of endoxifen was 22.8 (11.3), 15.9 (9.2), 8.1 (4.9) and 5.6 (3.8) ng/mL in 27 ultrarapid, 1,097 normal, 164 intermediate an
- end
- 6743
- exact text
- NCT00003787
- start
- 6732
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00300.json
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source json pointer
- /results/91/clinical_pharmacology/0
- source kind
- fda_spl_label
- source record id
- 5bcbc281-342c-4b05-8409-53a08b1fc9f6
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 71d8a03306f44e5e0a07cc68a8a8b9463909486eff01e785c33324694d049762
- spl effective time
- 20211129
- spl set id
- 1e6ff055-590c-41e6-9530-1fdf04cdbd02
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-19339760be8f479ddf23
- requested nct id
- NCT00003787
- primary nct id
- NCT00003787
- source kind
- fda_spl_label
- source record id
- 5bcbc281-342c-4b05-8409-53a08b1fc9f6
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- payload sha256
- da277dcbe123eccd1b9ea739ac1ad0ee430859be9ee3728ef211482a5189e560
- payload
- application numbers
- NDA021807
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-19339760be8f479ddf23
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00003787
- occurrences
- context exact
- ional alleles of CYP2D6. In patients with estrogen receptor-positive breast cancer who were participating in the WHEL (Women's Health Eating and Living) Study (NCT00003787), the mean (SD) serum concentration of endoxifen was 22.8 (11.3), 15.9 (9.2), 8.1 (4.9) and 5.6 (3.8) ng/mL in 27 ultrarapid, 1,097 normal, 164 intermediate an
- end
- 456
- exact text
- NCT00003787
- start
- 445
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00300.json
- source file sha256
- bbaf8e3e49a06d91fa717d034adb1798932735c99e42d8d769cf5f9eb31d345e
- source json pointer
- /results/91/pharmacogenomics/0
- source kind
- fda_spl_label
- source record id
- 5bcbc281-342c-4b05-8409-53a08b1fc9f6
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 279017ff7a366680be71a22205818933b022bbf012351dfe219d628ba3037b68
- spl effective time
- 20211129
- spl set id
- 1e6ff055-590c-41e6-9530-1fdf04cdbd02
Preserved source evidence · Not medical advice