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Prospective, monocentric study evaluating the presence of sarcopenia prior to neoadjuvant chemotherapy and during chemotherapy as part of optimised management.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with inoperable high-grade ovarian carcinoma | Other | Evaluation of sarcopenia in patients with inoperable high-grade ovarian carcinoma as part of optimised management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the date of surgery to the start date of adjuvant chemotherapy, assessed up to 2 months from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre GEKIERE, MD | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Bordeaux | France |
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|
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D043384 | Glutamyl Aminopeptidase |
| ID | Term |
|---|---|
| D000626 | Aminopeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |
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