Evaluation of Amino Acid Metabolism Changes in Ovarian Cancer (AMINOCANCER)

May 17, 2024 updated by: University Hospital, Grenoble

Evaluation of Amino Acid Metabolism Changes in Participants With Ovarian Cancer by Dynamic Test

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France
        • Recruiting
        • Chu Grenoble Alpes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynamic test
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
degree of consumption of each amino acid estimated by the difference in plasma concentration in µmol/L measured after 90 minutes (H 1.5) and 270 minutes (H 4.5) of perfusion.
270 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC20.038
  • 2022-A01369-34 (Other Identifier: ID/RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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