Prehabilitation program for older women with advanced ovarian cancer undergoing surgery
Prehabilitation & Rehabilitation in Oncogeriatrics: Adaptation to Deconditioning Risk and Accompaniment of Patients' Trajectories-ovary/Elderly Women With Ovarian Cancer-2, a GINECO Multicenter Randomized Study (PROADAPT-ovary/EWOC-2)
NA · Hospices Civils de Lyon · NCT04284969
This study is testing a prehabilitation program that helps older women with advanced ovarian cancer prepare for surgery to see if it can improve their recovery and reduce complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 292 (estimated) |
| Ages | 70 Years and up |
| Sex | Female |
| Sponsor | Hospices Civils de Lyon (other) |
| Drugs / interventions | chemotherapy |
| Locations | 11 sites (Bordeaux and 10 other locations) |
| Trial ID | NCT04284969 on ClinicalTrials.gov |
What this trial studies
The PROADAPT-ovary/EWOC-2 initiative focuses on enhancing surgical outcomes for older women with advanced ovarian cancer through a comprehensive prehabilitation program. This program includes nutritional, physical, and educational preparation before surgery, optimization of treatments during hospitalization, and support for a smooth transition from hospital to home post-surgery. The intervention is designed based on a validated rehabilitation model and aims to reduce complications associated with major cancer surgery in the elderly population. The approach is being evaluated across multiple hospitals to assess its effectiveness in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 70 and older, or those aged 60 and older with significant comorbidities or disabilities, who have been diagnosed with advanced ovarian cancer.
Not a fit: Patients with other progressive malignant tumors or those whose treatment does not include cytoreductive surgery may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly reduce surgical complications and improve recovery for older women undergoing treatment for advanced ovarian cancer.
How similar studies have performed: While prehabilitation has shown promise in improving outcomes for surgical patients, this specific multi-faceted approach in older women with ovarian cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Woman ≥70 year old OR Woman ≥60 years with significant comorbid condition (modified Charlson index≥3) or disability (ADL score\<6/6); * Histologically or cytologically proven FIGO (International Federation of Gynecology and Obstetrics) stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125/CEA \>25 and a radiological pelvic mass. * Patient oriented towards a complex medical procedure defined by pelvic surgery preceded or not by antineoplastic treatment (neoadjuvant chemotherapy). * Therapeutic decision validated in a multidisciplinary consultation meeting * Life expectancy \> 3 months. * Written informed consent obtained. * Covered by a Health System where applicable. Exclusion Criteria: * Any other progressive malignant tumor interfering with the patient's prognosis. * Patient whose validated therapeutic management does not include cytoreductive surgery. * Patient unable to be regularly followed up for any reason (geographic, family, social, psychological). * Patient unable to understand the questionnaires. * Patient unable to follow and adhere to test procedures for geographic, social or psychological reasons. * Patient placed under guardianship or curatorship. * Patient deprived of liberty. * Concurrent participation in another interventional drug trial. * Patient already included in this study
Where this trial is running
Bordeaux and 10 other locations
- Chu Bordeaux Pellegrin — Bordeaux, France (COMPLETED)
- CH Métropole Savoie — Chambéry, France (RECRUITING)
- Centre Georges François Leclerc — Dijon, France (RECRUITING)
- Hôpital Croix Rousse — Lyon, France (RECRUITING)
- Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet — Pierre-Bénite, France (RECRUITING)
- Centre hospitalier Annecy Genevois — Pringy, France (RECRUITING)
- CHU de St Etienne - Service gynécologie — Saint-Priest-en-Jarez, France (RECRUITING)
- CHU Nord Saint Etienne - Service oncologie médicale — Saint-Priest-en-Jarez, France (RECRUITING)
- Institut Gustave Roussy — Villejuif, France (RECRUITING)
- Médipôle Hôpital Mutualiste — Villeurbanne, France (RECRUITING)
- Villeurbanne Médipole MHP — Villeurbanne, France (RECRUITING)
Study contacts
- Study coordinator: Claire FALANDRY, PR
- Email: claire.falandry@chu-lyon.fr
- Phone: 4.78.86.32.87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, Surgery, Cytoreductive surgery, Older, Senior adult, Prehabilitation