“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”

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.

The comparison of functional status and health-related parameters in ovarian cancer survivors with healthy controls

“…Our results also demonstrated that advanced-stage OC survivors had experienced higher levels of fatigue similar to the previous findings on this subject [ 42 ]. Muscle strength, neuropathy, mobility, depression, anxiety, and exercise intolerance may all contribute to fatigue [ 7 , 33 ], which may explain the difference between OC survivor subgroups.…”

“…OC patients commonly experience a varied range of physical and psychological symptoms resulting from the chronic disease process and the adverse effects of these treatments [ 2 , 6 ]. These symptoms and related consequences include neuropathy, loss of muscle strength, fatigue, decreased mobility, exercise intolerance, dyspnea, and diminished health-related quality of life [ 7 , 8 ]. Furthermore, the adverse effects of local and systemic treatments on health-related components of physical fitness (muscle strength, exercise capacity, body composition) may still persist even during the survival phase of OC [ 8 – 10 ].…”

Prediction for 2-year mortality of metastatic ovarian cancer patients based on surveillance, epidemiology, and end results database

“…These suggested that surgery and chemotherapy should be operated in ovarian cancer patients based on the feasibility conditions of patients to improve the outcome of these patients. In addition, chemotherapy might be associated with some side-effects such as fatigue in patients, and intervention strategies should be proposed to improve the management of these patients during their treatment and in the long term ( 41 ). In the past, ovarian cancer was found to be a radiosensitive tumor, and radiation was one of the main therapies for patients with epithelial ovarian cancer, which was applied to manage patients with low residual volumes of disease ( 42 ).…”

Effectiveness and safety of nintedanib in prevention of pulmonary fibrosis induced by bleomycin in malignant ovarian germ cell tumour: study protocol for a randomised, double-blind, placebo-controlled trial

“…GOG-NTX uses 11 items to describe peripheral nerve disorders, such as numbness, discomfort, arthralgia, deep sensitivity problems and walking disorders. The detailed description has also been discussed in a previous study 27. A combination of these questionnaires can help demonstrate the life status of MOGCT patients after treatment.…”