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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03418844
Acronym
VIVROVAIRE TR
Enrollment
268
Registered
2018-02-01
Start date
2018-05-07
Completion date
2025-12-31
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Germ Cell Tumor, Malignant Non-epithelial Ovarian Tumors, Sex Cord Stromal Tumor

Brief 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

Interventions

OTHERSelf-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_TESTCardiac, 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

Sponsors

ARCAGY/ GINECO GROUP
CollaboratorOTHER
Centre Francois Baclesse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Patients and healthy volunteers will complete several self-questionnaires on living conditions and quality of life. Patients will also perform a cardiac, pulmonary, auditory and biological assessment

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
The chronic fatigue by questionnaires2 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 questionnaires2 years after surgery

Secondary

MeasureTime frame
The fertility monitoring by questionnaires2 years after surgery
The parental projects by age (≤ 45 years) by questionnaires2 years after surgery
The symptoms of menopause by questionnaires2 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026