Evaluation of Amino Acid Metabolism Changes in Ovarian Cancer

NCT ID: NCT06216496

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dynamic test

Group Type: EXPERIMENTAL

dynamic test for amino acid metabolism

Intervention Type: OTHER

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 glucose infusion (0.25g/kg/h of glucose)
• H4.5: Final blood sampling (amino acid assay) Each amino acid is plotted as a function of its perfusion rate on the abscissa and its variation in plasma concentration on the ordinate.

Interventions

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 glucose infusion (0.25g/kg/h of glucose)
• H4.5: Final blood sampling (amino acid assay) Each amino acid is plotted as a function of its perfusion rate on the abscissa and its variation in plasma concentration on the ordinate.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Grenoble Alpes

La Tronche, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Cécile Bétry

Role: primary

cbetry@chu-grenoble.fr

04 76 76 75 75

Other Identifiers

2022-A01369-34

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.038

Identifier Type: -

Identifier Source: org_study_id