Ovarian CarcinomaOPTIMOVANCT05415527
Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management
A study testing Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA). in people with Ovarian Carcinoma, run by Institut Bergonié at 1 site in France.
Trial summary
Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2022to 18 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Inoperable, high-grade, epithelial ovarian carcinoma requiring perioperative chemotherapy (neoadjuvant and adjuvant).
- Optical medical treatment (carboplatin-taxol chemotherapy every 3 weeks) and surgery at Institut Bergonié.
- Non-clinically undernourished patient, i.e. without loss of more than 10% bodyweight in 6 months
- Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any tests required for the research).
- Patient with social security cover in accordance with Article 1121-11 of the French code of public health.
Who cannot join
- Contraindication to CT-scans.
- Contraindication to bone mineral densitometry.
- Patients over the age of 70 the G8 of whom requires oncogeriatric surgery.
- Patients under guardianship, vulnerable patients or patients under any other legal protection measures.
- Geographic, social or psychological factors meaning the patient is unable to commit to study follow-up and procedures.
- Patient already included in this study or in another study evaluating the impact of sarcopenia.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.
Read the detailed description
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
Before inclusion,all eligibility criteria will be verified.
Sarcopenia in patients with inoperable, high-grade epithelial ovarian carcinoma will be evaluated at different times:
- before treatment, in the 30 days prior to their inclusion in the study,
- after 3 neoadjuvant chemotherapy cycles,
- after 3 adjuvant chemotherapy cycles,
- 9 months after surgery. The reference detection method is by CT-scan. This will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening.
On inclusion, the patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia.
This follow-up by a dietician and a physical fitness trainer will be recorded at each neoadjuvant chemotherapy session.
Dietary advice will be given each time along with personalised advice if weight loss were to be observed.
If undernutrition or a foreseeable risk of undernutrition are diagnosed, parenteral nutrition will be prescribed by the oncologist, the anaesthetist or the surgeon.
The objective of APA is to prevent the onset or aggravation of disease, to increase patient autonomy and quality-of-life, or even to help them return to social activities.
Respiratory preparation will also be offered to increase the patient's respiratory capacity in view of surgery, with exercises to be done using a respiratory training device.
- Conditions
- Ovarian Carcinoma
- Being tested
- Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).
- Keywords
- Inoperable high-grade ovarian carcinoma, Sarcopenia evaluation, nutritional monitoring, adapted physical activity
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).Other
Sarcopenia will be evaluated by CT-scan. This method will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening.
The patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia.
| Study group | Role | What they receive |
|---|---|---|
| patients with inoperable high-grade ovarian carcinoma | Other | Evaluation of sarcopenia in patients with inoperable high-grade ovarian carcinoma as part of optimised management Receives: Other: Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0).
Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0). According to the 2019 HAS guidelines [Diagnosis of undernutrition in children and adults, November 2019], we consider the patient to have sarcopenia if her MSI is strictly below 38.5 cm2/m2.
Measured: Baseline
Secondary outcomes (1)
The time of access to chemotherapy
The time of access to chemotherapy is the time between the date of surgery and the adjuvant chemotherapy start date. Pretreatment sarcopenia is defined as for the primary endpoint.
Measured: From the date of surgery to the start date of adjuvant chemotherapy, assessed up to 2 months from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start11 Jun 2022
- Primary completion30 Apr 2025
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre GEKIERE, MD, Principal investigator, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415527
- Sponsor's protocol ID
- IB2021-05
- Other IDs
- ID-RCB 2021-A01992-39
- Acronym
- OPTIMOVA
- Status last verified
- Oct 2026
- First submitted
- 7 Jun 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pretreatment Sarcopenia in Patients With Inoperable High-grade Ovarian Carcinoma as Part of Optimised Management
- ClinicalTrials.gov ID
- NCT05415527
- Acronym / sponsor ID
- OPTIMOVA / IB2021-05
- Conditions
- Ovarian Carcinoma
- Keywords
- Inoperable high-grade ovarian carcinoma, Sarcopenia evaluation, nutritional monitoring, adapted physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- 11 Jun 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.
Detailed description
Prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study.
Before inclusion,all eligibility criteria will be verified.
Sarcopenia in patients with inoperable, high-grade epithelial ovarian carcinoma will be evaluated at different times:
- before treatment, in the 30 days prior to their inclusion in the study,
- after 3 neoadjuvant chemotherapy cycles,
- after 3 adjuvant chemotherapy cycles,
- 9 months after surgery. The reference detection method is by CT-scan. This will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening.
On inclusion, the patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia.
This follow-up by a dietician and a physical fitness trainer will be recorded at each neoadjuvant chemotherapy session.
Dietary advice will be given each time along with personalised advice if weight loss were to be observed.
If undernutrition or a foreseeable risk of undernutrition are diagnosed, parenteral nutrition will be prescribed by the oncologist, the anaesthetist or the surgeon.
The objective of APA is to prevent the onset or aggravation of disease, to increase patient autonomy and quality-of-life, or even to help them return to social activities.
Respiratory preparation will also be offered to increase the patient's respiratory capacity in view of surgery, with exercises to be done using a respiratory training device.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with inoperable high-grade ovarian carcinoma | Other | Other: Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).Evaluation of sarcopenia in patients with inoperable high-grade ovarian carcinoma as part of optimised management |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Inoperable, high-grade, epithelial ovarian carcinoma requiring perioperative chemotherapy (neoadjuvant and adjuvant).
- Optical medical treatment (carboplatin-taxol chemotherapy every 3 weeks) and surgery at Institut Bergonié.
- Non-clinically undernourished patient, i.e. without loss of more than 10% bodyweight in 6 months
- Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any tests required for the research).
Key exclusion criteria (6 listed)
- Contraindication to CT-scans.
- Contraindication to bone mineral densitometry.
- Patients over the age of 70 the G8 of whom requires oncogeriatric surgery.
- Patients under guardianship, vulnerable patients or patients under any other legal protection measures.
- Geographic, social or psychological factors meaning the patient is unable to commit to study follow-up and procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA).Sarcopenia will be evaluated by CT-scan. This method will be combined with a bone mineral density test which is also a way of entering into a more specific approach to sarcopenia screening. The patients will receive optimised treatment by nutritional monitoring and adapted physical activity (APA) in addition to follow-up for sarcopenia. | Other | patients with inoperable high-grade ovarian carcinoma |
Primary outcome
Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0).
Time frame: Baseline
Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0). According to the 2019 HAS guidelines [Diagnosis of undernutrition in children and adults, November 2019], we consider the patient to have sarcopenia if her MSI is strictly below 38.5 cm2/m2.
1 secondary outcome
The time of access to chemotherapy
Time frame: From the date of surgery to the start date of adjuvant chemotherapy, assessed up to 2 months from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre GEKIERE, MD principal investigator
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presence of sarcopenia evaluated prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management(dietician and APA). in people with Ovarian Carcinoma, run by Institut Bergonié at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with pretreatment sarcopenia identified by analysis of the baseline CT-scan (CT0). (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.