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NCT Number: NCT06216496

Evaluation of Amino Acid Metabolism Changes in Ovarian Cancer

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dynamic test for amino acid metabolism

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: AMINOCANCER

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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