Can Pre-Surgery training help older ovarian cancer patients recover better?
NCT ID NCT04284969
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a program called PROADAPT for women aged 70 and older with advanced ovarian cancer who need surgery. The program includes exercise, nutrition advice, education, and medication management before and after surgery. The goal is to see if it reduces serious complications and improves quality of life. About 292 participants will be randomly assigned to the program or standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PROADAPT program (behavioral intervention including exercise, nutrition, education, and medication management)
- What this could lead to
- If successful, this program could help elderly ovarian cancer patients recover faster and with fewer complications after surgery.
- What could go wrong
- This is a relatively early-stage study (Phase NA) with 292 participants, so results may not apply to all patients. The program is complex and may be hard to implement consistently across hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 292 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CH Métropole Savoie
RECRUITINGChambéry, 73000, France
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CHU Nord Saint Etienne - Service oncologie médicale
RECRUITINGSaint-Priest-en-Jarez, 42270, France
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CHU de St Etienne - Service gynécologie
RECRUITINGSaint-Priest-en-Jarez, 42270, France
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Centre Georges François Leclerc
RECRUITINGDijon, 21079, France
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Centre hospitalier Annecy Genevois
RECRUITINGPringy, 74374, France
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Chu Bordeaux Pellegrin
COMPLETEDBordeaux, 33000, France
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Hôpital Croix Rousse
RECRUITINGLyon, 69004, France
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Institut Gustave Roussy
RECRUITINGVillejuif, 94805, France
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Médipôle Hôpital Mutualiste
RECRUITINGVilleurbanne, 69616, France
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Service de Gériatrie, Centre Hospitalier Lyon Sud, 165 chemin du Grand Revoyet
RECRUITINGPierre-Bénite, 69495, France
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Villeurbanne Médipole MHP
RECRUITINGVilleurbanne, 69616, France
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Other studies related to the condition(s) this trial covers.
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- Fixing broken ribs with surgery may cut pain better than drugs alone
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?