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

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ClinicalTrials.gov Identifier: NCT03418844
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
ARCAGY/ GINECO GROUP
Information provided by (Responsible Party):
Centre Francois Baclesse

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


Condition or disease Intervention/treatment Phase
Germ Cell Tumor Sex Cord Stromal Tumor Malignant Non-epithelial Ovarian Tumors Other: Self-questionnaires of living conditions and quality of life Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418844


Contacts
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Contact: Florence JOLY, PhD 33 2 31 45 50 02 f.joly@baclesse.unicancer.fr

Locations
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France
CHU Besançon Jean MINJOZ Not yet recruiting
Besançon, France
Contact: Elsa KALBACHER, MD         
Principal Investigator: Elsa KALBACHER, MD         
Sub-Investigator: Fernando BAZAN, MD         
Sub-Investigator: Martin DEMARCHI, MD         
Sub-Investigator: Laura MANSI, MD         
Institut Bergonié Not yet recruiting
Bordeaux, France
Contact: Anne FLOQUET, MD         
Principal Investigator: Anne FLOQUET, MD         
Sub-Investigator: Frederic GUYON, MD         
Sub-Investigator: Camille CHAKIBA-BRUGERE, MD         
CH Fleyriat Not yet recruiting
Bourg-en-Bresse, France
Contact: Hubert ORFEUVRE, MD         
Principal Investigator: Hubert ORFEUVRE, MD         
Centre François Baclesse Recruiting
Caen, France
Contact: Florence JOLY, PhD    33 2 31 45 50 02    f.joly@baclesse.unicancer.fr   
Contact: Jean-Michel GRELLARD    33 2 31 45 50 02    jm.grellard@baclesse.unicancer.fr   
Principal Investigator: Florence JOLY, PhD         
Sub-Investigator: Laura MOISE, MD         
Sub-Investigator: Elodie COQUAN, MD         
Sub-Investigator: Pierre-Emmanuel BRACHET, MD         
Sub-Investigator: Emeline MERIAUX, MD         
Centre Jean Perrin Not yet recruiting
Clermont-Ferrand, France
Contact: Sophie DUBOIS, MD         
Sub-Investigator: Christophe POMEL, PhD         
Principal Investigator: Sophie DUBOIS, MD         
Sub-Investigator: Marie-Ange MOURET-REYNIER, MD         
Sub-Investigator: Morgane MASSON, MD         
Centre Léon Berard Recruiting
Lyon, France
Contact: Isabelle RAY-COQUARD, PhD         
Principal Investigator: Isabelle RAY-COQUARD, PhD         
Sub-Investigator: Christine ROUSSET-JABLONSKI, MD         
Sub-Investigator: Olivier TREDAN, MD         
Sub-Investigator: Pierre-Etienne HEUDEL, MD         
Sub-Investigator: Pauline ROCHEFORT, MD         
Sub-Investigator: Mehdi BRAHMI, MD         
Sub-Investigator: Nicolas CHOPIN, MD         
Sub-Investigator: Pierre MEEUS, MD         
Institut Paoli Calmettes Not yet recruiting
Marseille, France
Contact: Magali PROVENSAL, MD         
Principal Investigator: Magali PROVENSAL, MD         
Centre Catherine de Sienne Not yet recruiting
Nantes, France
Contact: Alain LORTHOLARY, MD         
Principal Investigator: Alain LORTHOLARY, MD         
Sub-Investigator: Claude EL KOURI, MD         
Sub-Investigator: Dorothée CHOCTEAU-BOUJU, MD         
Sub-Investigator: Hélène CASTANIE, MD         
Sub-Investigator: Benjamin LINOT, MD         
Institut de Cancérologie de l'Ouest Recruiting
Nantes, France
Contact: Dominique BERTON-RIGAUD, MD         
Principal Investigator: Dominique BERTON-RIGAUD, MD         
Sub-Investigator: Emmanuelle BOURBOULOUX, MD         
Sub-Investigator: Carole GOURMELON, MD         
Sub-Investigator: Jean-Sebastien FRENEL, MD         
Sub-Investigator: Marie ROBERT, MD         
GH Cochin Broca Hôtel-Dieu Not yet recruiting
Paris, France
Contact: Jérôme ALEXANDRE, PhD         
Principal Investigator: Jérôme ALEXANDRE, PhD         
Sub-Investigator: Anh Tuan DINXH-XUAN, PhD         
Institut Gustave Roussy Recruiting
Paris, France
Contact: Patricia PAUTIER, MD         
Principal Investigator: Patricia PAUTIER, MD         
Sub-Investigator: Alexandra LEARY, MD         
Sub-Investigator: Judith MICHELS, MD         
Sub-Investigator: Fanny POMMERET, MD         
CHU Poitiers Not yet recruiting
Poitiers, France
Contact: Cedric NADEAU, MD         
Principal Investigator: Cedric NADEAU, MD         
Institut Jean Godinot Not yet recruiting
Reims, France
Contact: Aude-Marie SAVOYE, MD         
Principal Investigator: Aude-Marie SAVOYE, MD         
Institut Rennais de Cancérologie Not yet recruiting
Rennes, France
Contact: Thibault DE LA MOTTE ROUGE, MD         
Principal Investigator: Thibault DE LA MOTTE ROUGE, MD         
CHRU Stasbourg Hôpital Civil Not yet recruiting
Strasbourg, France
Contact: Laure DE COCK, MD         
Principal Investigator: Laure DE COCK, MD         
Sub-Investigator: Jean-Emmanuel KURTZ, PhD         
Sponsors and Collaborators
Centre Francois Baclesse
ARCAGY/ GINECO GROUP
Investigators
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Principal Investigator: Florence JOLY Centre François Baclesse

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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT03418844     History of Changes
Other Study ID Numbers: VIVROVAIRE TR
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatigue
Neoplasms, Germ Cell and Embryonal
Ovarian Neoplasms
Sex Cord-Gonadal Stromal Tumors
Signs and Symptoms
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Gonadal Tissue