Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy (VIVROVAIRE TR)

While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored.

The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy

Study Overview

• Status: Active, not recruiting
• Conditions: Germ Cell Tumor; Sex Cord Stromal Tumor; Malignant Non-epithelial Ovarian Tumors
• Intervention / Treatment: Other: Self-questionnaires of living conditions and quality of life; Diagnostic test: Cardiac, pulmonary, auditory and biological assessment

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre Paul Papin
  • Besançon, France
    • CHU Besançon Jean MINJOZ
  • Bordeaux, France
    • Institut Bergonie
  • Bourg-en-Bresse, France
    • CH Fleyriat
  • Caen, France
    • Centre Francois Baclesse
  • Clermont-Ferrand, France
    • Centre Jean Perrin
  • Lyon, France
    • Centre Leon Berard
  • Marseille, France
    • Institut Paoli Calmettes
  • Nantes, France
    • Institut de Cancerologie de L'Ouest
  • Nantes, France
    • Centre Catherine de Sienne
  • Paris, France
    • Institut Gustave Roussy
  • Paris, France
    • GH Cochin Broca Hôtel-Dieu
  • Paris, France
    • Hôpital Diaconesses-Croix St Simon
  • Paris, France
    • Institut Curie,
  • Poitiers, France
    • CHU Poitiers
  • Reims, France
    • Institut Jean Godinot
  • Rennes, France
    • Institut Rennais de Cancérologie
  • Strasbourg, France
    • CHRU Stasbourg Hôpital Civil
  • Paris
    • Paris, Paris, France
      • HEGP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age> 18 years;
• Patient with an ovarian malignant germ cell tumor (TGMO) or a stroma tumor and / or sex cords (TSCS) treated optimally;
• Patient who has had surgery and chemotherapy (interest group) or only a surgery (control group);
• Patient in remission more than 2 years after the end of the initial treatment;
• Relapse authorized if remission more than 2 years after the end of the treatment;
• Patient with no other cancers (with the exception of basal cell skin carcinomas, in situ cancers of the breast and cervix);
• Patient having signed his consent to participate

Exclusion Criteria:

• Pregnant or breastfeeding woman;
• Psychiatric pathology that may disrupt the course of the study or prevent the interpretation of results;
• Person deprived of liberty;
• Major subject to a legal protection measure or unable to express his consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interest group (patients treated with chemotherapy); Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment	Other: Self-questionnaires of living conditions and quality of life; Patients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire); Diagnostic test: Cardiac, pulmonary, auditory and biological assessment; Patients will perform : Cardiac assesments (ECG, Carotid and humeral Doppler ultrasound, Trans-thoracic echocardiography 2D and 3D); Pulmonary and auditory assesment ( Respiratory Functional Exploration, Tonal audiogram); Blood tests
Other: Patient control group (patients not treated with chemotherapy); Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment	Other: Self-questionnaires of living conditions and quality of life; Patients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire); Diagnostic test: Cardiac, pulmonary, auditory and biological assessment; Patients will perform : Cardiac assesments (ECG, Carotid and humeral Doppler ultrasound, Trans-thoracic echocardiography 2D and 3D); Pulmonary and auditory assesment ( Respiratory Functional Exploration, Tonal audiogram); Blood tests
Other: Healthy volunteers; Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.	Other: Self-questionnaires of living conditions and quality of life; Patients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The chronic fatigue by questionnaires	2 years after surgery
The late sequelae of chemotherapy, particularly cardiovascular and pulmonary disorders, in adult patients in remission of a rare cancer of the ovary treated by surgery, supplemented or not by chemotherapy.	2 years after surgery
The quality of life by questionnaires	2 years after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
The fertility monitoring by questionnaires	2 years after surgery
The symptoms of menopause by questionnaires	2 years after surgery
Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);	2 years after surgery
The parental projects by age (≤ 45 years) by questionnaires	2 years after surgery

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse
• Collaborators: ARCAGY/ GINECO GROUP
• Investigators: Principal Investigator: Florence JOLY, Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): July 13, 2021
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 15, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Gonadal Tissue; Neoplasms, Germ Cell and Embryonal; Sex Cord-Gonadal Stromal Tumors; Public Health; Environment and Public Health; Health Status; Demography; Epidemiologic Measurements; Quality of Life
• Other Study ID Numbers: VIVROVAIRE TR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No