'Chronic fatigue, quality of life and long-term side-effects of chemotherapy in patients treated for non-epithelial ovarian cancer: national case-control protocol study of the GINECO-Vivrovaire rare tumors INCa French network for rare malignant ovarian tumors'

Autor: Anaïs Lelaidier, Patricia Pautier, Aude-Marie Savoye, H. Orfeuvre, Dominique Berton-Rigaud, Héloise Bourien, Alain Lortholary, Lionel Perrier, Djihane Ahmed-Lecheheb, Thibaut De La Motte Rouge, Jérôme Alexandre, Amandine Charreton, Elsa Kalbacher, Sophie Frank, Jean-Michel Grellard, François Gernier, Jean-Emmanuel Kurtz, Anne Floquet, Frédéric Selle, Isabelle Ray-Coquard, Idlir Licaj, Paule Augereau, Katia Kerdja, Cédric Nadeau, Fabien Labombarda, Florence Joly, Bénédicte Clarisse
Přispěvatelé: Groupe d'analyse et de théorie économique (GATE Lyon Saint-Étienne), Centre National de la Recherche Scientifique (CNRS)-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université Lumière - Lyon 2 (UL2)-École normale supérieure - Lyon (ENS Lyon), Groupe d'Analyse et de Théorie Economique Lyon - Saint-Etienne (GATE Lyon Saint-Étienne), École normale supérieure de Lyon (ENS de Lyon)-Université Lumière - Lyon 2 (UL2)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS)
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Quality of life
Male
Oncology
Cancer Research
medicine.medical_specialty
medicine.medical_treatment
Survivorship
Study Protocol
Physical sequelae
03 medical and health sciences
0302 clinical medicine
Surgical oncology
Surveys and Questionnaires
Internal medicine
Genetics
Chemotherapy
Humans
Medicine
030212 general & internal medicine
Survival rate
RC254-282
Fatigue
Etoposide
Testicular cancer
Ovarian Neoplasms
Germ cell ovarian neoplasms
Fatigue Syndrome
Chronic
business.industry
Standard treatment
Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Middle Aged
medicine.disease
[SHS.ECO]Humanities and Social Sciences/Economics and Finance
3. Good health
Survival Rate
Case-Control Studies
030220 oncology & carcinogenesis
Sex cord stromal tumors
Long-term effects
Female
France
Germ cell tumors
Cardiovascular and pulmonary disorders
business
Ovarian cancer
medicine.drug
Zdroj: BMC Cancer
BMC Cancer, BioMed Central, 2021, 21 (1), ⟨10.1186/s12885-021-08864-8⟩
BMC Cancer, 2021, 21 (1), ⟨10.1186/s12885-021-08864-8⟩
BMC Cancer, Vol 21, Iss 1, Pp 1-12 (2021)
ISSN: 1471-2407
Popis: Background Germ cell tumors and sex cord stromal tumors are rare cancers of the ovary. They mainly affect young women and are associated with a high survival rate. The standard treatment mainly involves conservative surgery combined with chemotherapy [bleomycin, etoposide and cisplatin (BEP)] depending on the stage and the prognostic factors, as for testicular cancers. As reported in testicular cancer survivors, chemotherapy may induce sequelae impacting quality of life, which has not yet been evaluated in survivors of germ cell tumors and sex cord stromal tumors. The GINECO-VIVROVAIRE-Rare tumor study is a two-step investigation aiming to assess i) chronic fatigue and quality of life and ii) long-term side-effects of chemotherapy with a focus on cardiovascular and pulmonary disorders. Methods Using self-reported questionnaires, chronic fatigue and quality of life are compared between 134 ovarian cancer survivors (cancer-free ≥2 years after treatment) treated with surgery and chemotherapy and 2 control groups (67 ovarian cancer survivors treated with surgery alone and 67 age-matched healthy women). Medical data are collected from patient records. In the second step evaluating the long-term side-effects of chemotherapy, a subgroup of 90 patients treated with chemotherapy and 45 controls undergo the following work-up: cardiovascular evaluation (clinical examination, non-invasive cardiovascular tests to explore heart disease, blood tests), pulmonary function testing, audiogram, metabolic and hormonal blood tests. Costs of sequelae will be also assessed. Patients are selected from the registry of the INCa French Network for Rare Malignant Ovarian Tumors, and healthy women by the ‘Seintinelles’ connected network (collaborative research platform). Discussion This study will provide important data on the potential long-term physical side-effects of chemotherapy in survivors of Germ Cell Tumors (GCT) and Sex Cord Stromal Tumors (SCST), especially cardiovascular and pulmonary disorders, and neurotoxicity. The identification of long-term side-effects can contribute to adjusting the treatment of ovarian GCT or SCST patients and to managing follow-up with adapted recommendations regarding practices and chemotherapy regimens, in order to reduce toxicity while maintaining efficacy. Based on the results, intervention strategies could be proposed to improve the management of these patients during their treatment and in the long term. Trial registration This trial was registered at clinicaltrials.gov: 03418844, on 1 February 2018. This trial was registered on 25 October 2017 under the unique European identification number (ID-RCB): 2017-A03028–45. Recruitment Status: Recruiting. Protocol version Version n° 4.2 dated from Feb 19, 2021. Trial sponsor Centre François Baclesse, 3 avenue du Général Harris, F-14076 Caen cedex 05, France.
Databáze: OpenAIRE
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