Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk of Fertility Loss Caused by Chemotherapy
1. oktober 2020 oppdatert av: Latin American Cooperative Oncology Group
Evaluation of the Attitude of Pre Menopausal Women With Breast Cancer Faced With the Risk
To evaluate the attitude of pre menopausal women with breast cancer faced with the risk of loss of fertility caused by chemotherapy using EORTC's Fertility Questionnaire.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
To characterize the attitude of pre menopausal patients with breast cancer regarding the risks of infertility based on the following variables:
- Age at diagnosis
- Number of children
- Will of having children
- Marital status
- Scholarity
- Period of time from the diagnosis
- Time of the last menstruation period
- Chemotherapy administration
- Clinical staging at the diagnosis
- Pathological evaluation
- Documentation of the cancer therapy
Studietype
Observasjonsmessig
Registrering (Faktiske)
343
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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São Paulo, Brasil
- Hospital Perola Byington
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brasil
- CPO - Pucrs
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Porto Alegre, Rio Grande Do Sul, Brasil
- HCPA
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Havana, Cuba
- Instituto Nacional de Oncologia y Radiobiologia
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Toluca de Lerdo, Mexico
- Cenro Oncologico Estatal ISSEMYM
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Surquillo, Peru
- INEN
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Puerto Cabello, Venezuela
- Hospital de Clínicas San Agustín
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 40 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Pre menopausal women diagnosed with breast cancer prior treatment
Beskrivelse
Inclusion Criteria:
- Women with age ≥ 18 and ≤ 40
- Indication of (neo) adjuvant chemotherapy
- Prior chemotherapy treatment
- Patients with menstrual periods in the last 6 months
- In use of contraceptive methods
- Without breast cancer recurrence
- Capacity to read and understand the informed consent
Exclusion Criteria:
- Patients which received or with indication of definitive ovarian suppression (surgery and/or radiotherapy), except temporary pharmacological ovarian suppression
- Patients whom initiated chemotherapy treatment before entering the study
- Altered state of mind, dementia, or any other psychiatry problem that can interfere in the comprehension or interpretation of the informed consent.
- Previous diagnosis of infertility
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Pre menopausal women with breast cancer
Pre menopausal women with breast cancer prior treatment in face of infertility evoked by chemotherapy
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To analyze the number of pre-menopausal patients diagnosed with breast cancer that did not agree in receiving chemotherapy due to the risk of infertility
Tidsramme: Baseline and 1 year after after the first interview
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Baseline and 1 year after after the first interview
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Sivilstatus
Tidsramme: Grunnlinje
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Grunnlinje
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Infertility risk for breast cancer patients after accepting chemotherapy
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Minimal percentage of cure necessary for patients accept the chemotherapy treatment
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Age when diagnosed
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Number of children
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Desire to have kids
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Scholarity
Tidsramme: Baseline
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Baseline
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Period of time since the diagnosis
Tidsramme: Baseline
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Baseline
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Chemotherapy scheme administration
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Period of time from the last menstruation period
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Description of quality of life of patients with the EORTC QLQ-BR23
Tidsramme: Baseline and 1 year after the first interview
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Baseline and 1 year after the first interview
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studieleder: Gustavo Werutsky, MD, Latin American Cooperative Oncology Group
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):133-4.
- Benson JR, Jatoi I, Keisch M, Esteva FJ, Makris A, Jordan VC. Early breast cancer. Lancet. 2009 Apr 25;373(9673):1463-79. doi: 10.1016/S0140-6736(09)60316-0.
- Cardoso F, Loibl S, Pagani O, Graziottin A, Panizza P, Martincich L, Gentilini O, Peccatori F, Fourquet A, Delaloge S, Marotti L, Penault-Llorca F, Kotti-Kitromilidou AM, Rodger A, Harbeck N; European Society of Breast Cancer Specialists. The European Society of Breast Cancer Specialists recommendations for the management of young women with breast cancer. Eur J Cancer. 2012 Dec;48(18):3355-77. doi: 10.1016/j.ejca.2012.10.004. Epub 2012 Oct 29.
- Colleoni M, Rotmensz N, Robertson C, Orlando L, Viale G, Renne G, Luini A, Veronesi P, Intra M, Orecchia R, Catalano G, Galimberti V, Nole F, Martinelli G, Goldhirsch A. Very young women (<35 years) with operable breast cancer: features of disease at presentation. Ann Oncol. 2002 Feb;13(2):273-9. doi: 10.1093/annonc/mdf039.
- Vallejos Sologuren C, Gómez HL, et al. Clinicopathologic and outcome variables of worse prognosis in premenopausal patients (pts) age 35 and younger. 2010 Breast Cancer Symposium. Abstract 65
- Reichman BS, Green KB. Breast cancer in young women: effect of chemotherapy on ovarian function, fertility, and birth defects. J Natl Cancer Inst Monogr. 1994;(16):125-9.
- Senkus E, Gomez H, Dirix L, Jerusalem G, Murray E, Van Tienhoven G, Westenberg AH, Bottomley A, Rapion J, Bogaerts J, Di Leo A, Neskovic-Konstantinovic Z. Attitudes of young patients with breast cancer toward fertility loss related to adjuvant systemic therapies. EORTC study 10002 BIG 3-98. Psychooncology. 2014 Feb;23(2):173-82. doi: 10.1002/pon.3384. Epub 2013 Aug 29.
- Gradishar WJ, Schilsky RL. Ovarian function following radiation and chemotherapy for cancer. Semin Oncol. 1989 Oct;16(5):425-36. No abstract available.
- Stearns V, Schneider B, Henry NL, Hayes DF, Flockhart DA. Breast cancer treatment and ovarian failure: risk factors and emerging genetic determinants. Nat Rev Cancer. 2006 Nov;6(11):886-93. doi: 10.1038/nrc1992. Epub 2006 Oct 12.
- Dnistrian AM, Schwartz MK, Fracchia AA, Kaufman RJ, Hakes TB, Currie VE. Endocrine consequences of CMF adjuvant therapy in premenopausal and postmenopausal breast cancer patients. Cancer. 1983 Mar 1;51(5):803-7. doi: 10.1002/1097-0142(19830301)51:53.0.co;2-v.
- Moore HCF, et al. Phase III trial (Prevention of Early Menopause Study [POEMS]-SWOG S0230) of LHRH analog during chemotherapy (CT) to reduce ovarian failure in earlystage, hormone receptor-negative breast cancer: An international Intergroup trial of SWOG, IBCSG, ECOG, and CALGB (Alliance). J Clin Oncol 32:5s, 2014 (suppl; abstr LBA505)
- Brandberg Y, Michelson H, Nilsson B, Bolund C, Erikstein B, Hietanen P, Kaasa S, Nilsson J, Wiklund T, Wilking N, Bergh J; Scandinavian Breast Group Study 9401. Quality of life in women with breast cancer during the first year after random assignment to adjuvant treatment with marrow-supported high-dose chemotherapy with cyclophosphamide, thiotepa, and carboplatin or tailored therapy with Fluorouracil, epirubicin, and cyclophosphamide: Scandinavian Breast Group Study 9401. J Clin Oncol. 2003 Oct 1;21(19):3659-64. doi: 10.1200/JCO.2003.07.020.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2015
Primær fullføring (Faktiske)
15. juni 2020
Studiet fullført (Faktiske)
15. juni 2020
Datoer for studieregistrering
Først innsendt
27. januar 2016
Først innsendt som oppfylte QC-kriteriene
8. august 2016
Først lagt ut (Anslag)
11. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. oktober 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. oktober 2020
Sist bekreftet
1. oktober 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LACOG 0414
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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