Evaluation of Amino Acid Metabolism Changes in Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dynamic test for amino acid metabolism.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: 40 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Amino Acid Metabolism Changes in Participants With Ovarian Cancer by Dynamic Test
Overview
Ovarian cancer is associated with undernutrition in more than half of all cases. The current management of undernutrition-cachexia in cancer is not specific. It is well recognized that the nutritional support currently offered to cancer patients is not effective in combating cachexia, which progresses inexorably, leading to the patient's death. It is therefore necessary to offer specific and adapted care, in particular by optimizing the quality of nitrogen intake. To achieve this, the investigators first need to define the specific amino acid requirements of cancer patients.
Interventions
- Other dynamic test for amino acid metabolism
Subjects are fasting, and the dynamic test is performed as follows: Placement of 1 peripheral venous line (for infusions). * H0-H1.5: infusion of a 10% glucose solution at increasing flow rate (3 steps of 30 min each: 0.06g/kg/h then 0.12g/kg/h then 0.25g/kg/h of glucose) * H1,5: initial blood sampling (amino acid assay) * H1.5-H4.5: infusion of amino acid solution (Aminoven 5%, Fresenius Kabi, Sèvres, France) at constant speed (flow rate 10.5 mg/kg/h of nitrogen or 1.30 ml/kg/H) in Y with glu
Primary outcome measures
- metabolism of each amino acid, in women with non-immediately resectable ovarian cancer (with or without peritoneal metastases) of high-grade serous type. [Time frame: 270 minutes]
Eligibility criteria
Inclusion criteria
- Histological diagnosis of high-grade serous ovarian cancer not immediately resectable (stage III or IVa) managed at Grenoble Alpes University Hospital.
- Affiliation to the French social security system.
- Able to understand and follow the instructions necessary for the conduct of the trial, and having given written consent for the study.
Exclusion criteria
- Significant active comorbidity requiring long-term drug treatment (e.g. organ failure, diabetes) or history of pathology likely to impact amino acid metabolism (e.g. urea or homocysteine cycle abnormalities, tyrosinemia, alkaptonuria, hyperprolinemia, organic aciduria).
- vegetarian or vegan diet
- difficult venous access
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
- Subject receiving more than 4,500 euros in compensation for participation in other research involving the human body in the 12 months preceding this study.
- Significant biological abnormalities (not explained by the underlying pathology for women with ovarian cancer)
- Liver metastases
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- CHU Grenoble Alpes — La Tronche
Identifiers
NCT: NCT06216496 · 38RC20.038 · 2022-A01369-34