“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” - HAL Accéder directement au contenu
Article dans une revue BMC Cancer Année : 2021

“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”

François Gernier
Djihane Ahmed-Lecheheb
  • Fonction : Auteur
Patricia Pautier
  • Fonction : Auteur
Anne Floquet
  • Fonction : Auteur
Cédric Nadeau
  • Fonction : Auteur
Sophie Frank
  • Fonction : Auteur
Jérôme Alexandre
  • Fonction : Auteur
Frédéric Selle
  • Fonction : Auteur
Dominique Berton-Rigaud
  • Fonction : Auteur
Elsa Kalbacher
  • Fonction : Auteur
Hubert Orfeuvre
  • Fonction : Auteur
Alain Lortholary
  • Fonction : Auteur
Paule Augereau
  • Fonction : Auteur
Fabien Labombarda
  • Fonction : Auteur
Jean-Michel Grellard
  • Fonction : Auteur
Idlir Licaj
  • Fonction : Auteur
  • PersonId : 764022
  • IdRef : 171458389
Bénédicte Clarisse
  • Fonction : Auteur
Aude-Marie Savoye
Héloise Bourien
  • Fonction : Auteur
Thibaut de La Motte Rouge
  • Fonction : Auteur
Jean-Emmanuel Kurtz
Katia Kerdja
  • Fonction : Auteur
Anaïs Lelaidier
  • Fonction : Auteur
Amandine Charreton
  • Fonction : Auteur
Isabelle Ray-Coquard
Florence Joly
  • Fonction : Auteur

Résumé

Abstract 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.
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Dates et versions

halshs-03428068, version 1 (14-11-2021)

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François Gernier, Djihane Ahmed-Lecheheb, Patricia Pautier, Anne Floquet, Cédric Nadeau, et al.. “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”. BMC Cancer, 2021, 21 (1), ⟨10.1186/s12885-021-08864-8⟩. ⟨halshs-03428068⟩
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