Undersøgelse om kvinders sunde kostvaner og levevis
Diætintervention hos kvinder, der er blevet behandlet for trin I, trin II eller trin III brystkræft: Kvinders sunde kost og levevis (WHEL) undersøgelse
RATIONALE: Kostfedt, frugt, grøntsager og fibre kan påvirke risikoen for gentagelse af brystkræft.
FORMÅL: Randomiseret klinisk forsøg for at bestemme effektiviteten af en kost rig på grøntsager, frugt og fibre og lavt fedtindhold hos kvinder, der er blevet behandlet for stadium I, stadium II eller stadium III brystkræft.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL: I. Bestem, om en kost rig på grøntsager, frugt og fibre og lavt fedtindhold er forbundet med et længere brystkræfthændelsesfrit interval hos brystkræftoverlevere. II. Motiver en interventionsgruppe af brystkræftoverlevere til at vedtage og opretholde et kostmønster, der er rigt på grøntsager, frugt og fibre og lavt fedtindhold. III. Demonstrere, at interventionen kan frembringe væsentlige ændringer i cirkulerende carotenoid- og østrogenbiomarkører sammenlignet med en sund kontroldiæt. IV. Test, om sandsynligheden for en sekundær cancerhændelse er forbundet med ændring i selvrapporteret kostindtag, cirkulerende carotenoidkoncentrationer og cirkulerende østrogenkoncentrationer.
OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne stratificeres efter alder (under 55 vs. 55 og derover på diagnosetidspunktet), stadium af tumor (stadie I og mindst 1 cm vs. stadium II/IIIA) og klinisk sted. Patienter randomiseres til en af to sunde kostregimer: Arm I: Patienter læres at følge et kostmønster, der vil frembringe væsentlige ændringer i cirkulerende carotenoid- og østrogenbiomarkører. Arm II: Patienter tildeles til at følge kostråd fastsat af National Cancer Institute og USDA. Alle patienter deltager i 24 timers kosttilbagekaldelser, madlavningskurser samt udfylder adskillige spørgeskemaer ved baseline og derefter efter 12, 24 eller 36, 48 og 72 måneder; en tilfældigt udvalgt 50 % stikprøve deltager i tilbagekaldelse efter 6 måneder. Patienterne følges telefonisk hver 6. måned i gennemsnitligt 6 år.
PROJEKTERET OPSLAG: I alt 3.000 kvinder vil blive optjent til denne undersøgelse inden for 5 år.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Cancer Center
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California
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La Jolla, California, Forenede Stater, 92093-0658
- University of California San Diego Cancer Center
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Oakland, California, Forenede Stater, 94611-5400
- Permanente Medical Group (060)
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Sacramento, California, Forenede Stater, 95616
- University of California Davis School of Medicine
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Union City, California, Forenede Stater, 94587
- Northern California Cancer Center
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Oregon
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Portland, Oregon, Forenede Stater, 97227-1110
- Center for Health Research - Portland
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas - MD Anderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
SYGDOMSKARAKTERISTIKA: Primært operabelt stadium I (tumorer mindst 1 cm), stadium II og stadium IIIA invasivt brystkarcinom Behandling inden for de seneste 4 år med total mastektomi og aksillær dissektion eller brystbesparende kirurgisk fjernelse af cancer med klare makroskopiske marginer og aksillære dissektion efterfulgt af adjuverende bryststråling Ingen tegn på tilbagevendende sygdom eller ny brystkræft siden afslutning af indledende lokal behandling bekræftet inden for de seneste 6 måneder af lægeevaluering, undtagen fase I mastektomi, for hvilken lægeevaluering kan ske inden for 1 år før randomisering Hormonreceptor status: Ikke angivet
PATIENT KARAKTERISTIKA: Alder: 18 til 70 på tidspunktet for diagnosen Køn: Kvinde Overgangsstatus: Ikke specificeret Ydeevnestatus: Ikke specificeret Forventet levetid: Mindst 10 år (eksklusive brystkræft) Hæmatopoietisk: Ikke specificeret Lever: Ingen skrumpelever Nyre: Ikke specificeret Andet : Ikke gravid Tilgængelig geografisk og telefonisk Kan kommunikere kostdata via 24-timers tilbagekaldelse af mad Kan forpligte sig til interventionsplanen Ingen komorbiditet, der kræver en specifik diæt eller tager en medicin, der kontraindikerer indtagelse af en kost med højt fiberindhold (f.eks. systemisk sklerodermi, andet fordøjelsesmalabsorptionssyndromer og insulinafhængig diabetes) Ingen anden primær eller tilbagevendende invasiv cancer inden for de seneste 10 år undtagen non-melanom hudkræft eller carcinom in situ i livmoderhalsen
TIDLIGERE SAMTYDENDE BEHANDLING: Biologisk terapi: Ikke specificeret Kemoterapi: Ingen samtidig kemoterapi Endokrin terapi: Ingen samtidig østrogenerstatningsterapi, inklusive vaginale østrogencremer Strålebehandling: Se sygdomskarakteristika Kirurgi: Se sygdomskarakteristika Andet: Ingen samtidige indskrivning i en anden klinisk undersøgelse. eller endepunkter, der ligner denne undersøgelse
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Intervention
kost med højt fiberindhold, høj vegetabilsk, fedtfattig kost
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Styring
NCI-anbefalet diæt
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Gentagelse af brystkræft
Tidsramme: Livstid
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Livstid
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Dødelighed
Tidsramme: Livstid
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Livstid
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Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: John P. Pierce, PhD, University of California, San Diego
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Rock CL, Natarajan L, Pu M, Thomson CA, Flatt SW, Caan BJ, Gold EB, Al-Delaimy WK, Newman VA, Hajek RA, Stefanick ML, Pierce JP; Women's Healthy Eating and Living Study Group. Longitudinal biological exposure to carotenoids is associated with breast cancer-free survival in the Women's Healthy Eating and Living Study. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):486-94. doi: 10.1158/1055-9965.EPI-08-0809. Epub 2009 Feb 3.
- Hernandez-Valero MA, Thomson CA, Hernandez M, Tran T, Detry MA, Theriault RL, Hajek RA, Pierce JP, Flatt SW, Caan BJ, Jones LA. 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. 2008 Aug;108(8):1323-9. doi: 10.1016/j.jada.2008.05.008.
- Mortimer JE, Flatt SW, Parker BA, Gold EB, Wasserman L, Natarajan L, Pierce JP; WHEL Study Group. Tamoxifen, hot flashes and recurrence in breast cancer. Breast Cancer Res Treat. 2008 Apr;108(3):421-6. doi: 10.1007/s10549-007-9612-x. Epub 2007 May 31.
- Saxe GA, Madlensky L, Kealey S, Wu DP, Freeman KL, Pierce JP. Disclosure to physicians of CAM use by breast cancer patients: findings from the Women's Healthy Eating and Living Study. Integr Cancer Ther. 2008 Sep;7(3):122-9. doi: 10.1177/1534735408323081.
- Hong S, Bardwell WA, Natarajan L, Flatt SW, Rock CL, Newman VA, Madlensky L, Mills PJ, Dimsdale JE, Thomson CA, Hajek RA, Chilton JA, Pierce JP. Correlates of physical activity level in breast cancer survivors participating in the Women's Healthy Eating and Living (WHEL) Study. Breast Cancer Res Treat. 2007 Jan;101(2):225-32. doi: 10.1007/s10549-006-9284-y. Epub 2006 Sep 21.
- 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, Parker BA, Greenberg ER, Flatt SW, Rock CL, Kealey S, Al-Delaimy WK, Bardwell WA, Carlson RW, Emond JA, Faerber S, Gold EB, Hajek RA, Hollenbach K, Jones LA, Karanja N, Madlensky L, Marshall J, Newman VA, Ritenbaugh C, Thomson CA, Wasserman L, Stefanick ML. 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. 2007 Jul 18;298(3):289-98. doi: 10.1001/jama.298.3.289.
- Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819.
- Saquib N, Flatt SW, Natarajan L, Thomson CA, Bardwell WA, Caan B, Rock CL, Pierce JP. 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. 2007 Oct;105(2):177-86. doi: 10.1007/s10549-006-9442-2. Epub 2006 Nov 23.
- Bardwell WA, Natarajan L, Dimsdale JE, Rock CL, Mortimer JE, Hollenbach K, Pierce JP. Objective cancer-related variables are not associated with depressive symptoms in women treated for early-stage breast cancer. J Clin Oncol. 2006 Jun 1;24(16):2420-7. doi: 10.1200/JCO.2005.02.0081. Epub 2006 May 1.
- Madlensky L, Flatt SW, Bardwell WA, Rock CL, Pierce JP; WHEL Study group. Is family history related to preventive health behaviors and medical management in breast cancer patients? Breast Cancer Res Treat. 2005 Mar;90(1):47-54. doi: 10.1007/s10549-004-2626-8.
- Newman VA, Thomson CA, Rock CL, Flatt SW, Kealey S, Bardwell WA, Caan BJ, Pierce JP; Women's Healthy Eating and Living (WHEL) Study Group. Achieving substantial changes in eating behavior among women previously treated for breast cancer--an overview of the intervention. J Am Diet Assoc. 2005 Mar;105(3):382-91; quiz 488. doi: 10.1016/j.jada.2004.12.008.
- Thomson CA, Giuliano AR, Shaw JW, Rock CL, Ritenbaugh CK, Hakim IA, Hollenbach KA, Alberts DS, Pierce JP. Diet and biomarkers of oxidative damage in women previously treated for breast cancer. Nutr Cancer. 2005;51(2):146-54. doi: 10.1207/s15327914nc5102_4.
- Thornton AA, Madlensky L, Flatt SW, Kaplan RM, Pierce JP. The impact of a second breast cancer diagnosis on health related quality of life. Breast Cancer Res Treat. 2005 Jul;92(1):25-33. doi: 10.1007/s10549-005-1411-7.
- Pierce JP, Newman VA, Flatt SW, Faerber S, Rock CL, Natarajan L, Caan BJ, Gold EB, Hollenbach KA, Wasserman L, Jones L, Ritenbaugh C, Stefanick ML, Thomson CA, Kealey S; Women's Healthy Eating and Living (WHEL) Study Group. Telephone counseling intervention increases intakes of micronutrient- and phytochemical-rich vegetables, fruit and fiber in breast cancer survivors. J Nutr. 2004 Feb;134(2):452-8. doi: 10.1093/jn/134.2.452.
- Rock CL, Flatt SW, Thomson CA, Stefanick ML, Newman VA, Jones L, Natarajan L, Pierce JP, Chang RJ, Witztum JL; Women's Healthy Eating and Living (WHEL) Study Group. Plasma triacylglycerol and HDL cholesterol concentrations confirm self-reported changes in carbohydrate and fat intakes in women in a diet intervention trial. J Nutr. 2004 Feb;134(2):342-7. doi: 10.1093/jn/134.2.342.
- Gold EB, Flatt SW, Pierce JP, Bardwell WA, Hajek RA, Newman VA, Rock CL, Stefanick ML. Dietary factors and vasomotor symptoms in breast cancer survivors: the WHEL Study. Menopause. 2006 May-Jun;13(3):423-33. doi: 10.1097/01.gme.0000185754.85328.44.
- Pierce JP, Faerber S, Wright FA, Rock CL, Newman V, Flatt SW, Kealey S, Jones VE, Caan BJ, Gold EB, Haan M, Hollenbach KA, Jones L, Marshall JR, Ritenbaugh C, Stefanick ML, Thomson C, Wasserman L, Natarajan L, Thomas RG, Gilpin EA; Women's Healthy Eating and Living (WHEL) study group. 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. 2002 Dec;23(6):728-56. doi: 10.1016/s0197-2456(02)00241-6.
- Wasserman L, Flatt SW, Natarajan L, Laughlin G, Matusalem M, Faerber S, Rock CL, Barrett-Connor E, Pierce JP. 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. 2004 Jan;28(1):49-56. doi: 10.1038/sj.ijo.0802481.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UCSD-980919
- CDR0000066920 (Registry Identifier: PDQ (Physician Data Query))
- UCSD-WHEL
- NCI-G99-1508
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