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

Germ Cell Tumor Clinical Trial

— VIVROVAIRE TR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03418844
• Other study ID #: VIVROVAIRE TR
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 7, 2018
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 268
• Est. completion date: December 2024
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Germ Cell Tumor
• Malignant Non-epithelial Ovarian Tumors
• Neoplasms, Germ Cell and Embryonal
• Ovarian Neoplasms
• Sex Cord Stromal Tumor

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The chronic fatigue by questionnaires		2 years after surgery
Primary	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
Primary	The quality of life by questionnaires		2 years after surgery
Secondary	The fertility monitoring by questionnaires		2 years after surgery
Secondary	The symptoms of menopause by questionnaires		2 years after surgery
Secondary	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
Secondary	The parental projects by age (= 45 years) by questionnaires		2 years after surgery