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NCT Number: NCT03418844

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Germ Cell Tumor Malignant Non-epithelial Ovarian Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Gonadal Tissue Sex Cord Stromal Tumor Sex Cord-Gonadal Stromal Tumors

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

HEGP, Paris, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-questionnaires of living conditions and quality of life

Other

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)

Cardiac, pulmonary, auditory and biological assessment

Diagnostic Test

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

Primary outcomes

  1. The chronic fatigue by questionnaires

    Time frame: 2 years after surgery

  2. 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.

    Time frame: 2 years after surgery

  3. The quality of life by questionnaires

    Time frame: 2 years after surgery

Secondary outcomes

  1. The fertility monitoring by questionnaires

    Time frame: 2 years after surgery

  2. The symptoms of menopause by questionnaires

    Time frame: 2 years after surgery

  3. Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);

    Time frame: 2 years after surgery

  4. The parental projects by age (≤ 45 years) by questionnaires

    Time frame: 2 years after surgery

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • ARCAGY/ GINECO GROUP

Registry information

Acronym: VIVROVAIRE TR

Important dates

Study start
2018
Primary completion
2021
Study completion
2025
First posted
Feb 1, 2018
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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