Category
»
Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
»
2023
INTERVENTION: D12.125.095.226 Experimental and control group: This is an evaluative, randomized, three‐arm, double‐blind, placebo‐controlled study. All patients are volunteers at the Hospital Regional do Câncer de Passos, located in the city of Passos MG, selected according to the type of gastrointestinal cancer they have and the duration of the chemotherapy cycle. A total of fifteen people of both sexes met the inclusion criteria for the study. Before supplementation, all patients will undergo an assessment of nutritional status, where weight and height will be evaluated, as well as additional information regarding weight loss, usual weight, muscle mass, muscle weakness and sarcopenia. Prior to data collection and filling out the questionnaires, a detailed anamnesis will be carried out (Appendi XI) containing information about identification, profession, age, family history of cancer, main GIT symptoms, lifestyle habits, physical examination, and food intake and symptoms of gastrointestinal cancers. The evaluation of the dietary pattern will be carried out using a food frequency questionnaire validated for colorectal cancer, the lifestyle will be evaluated with information from the medical records. For supplementation, the patients were divided into 3 groups according to the letter drawn (S, O, F), since all the pills came out of manipulation in unidentified packages, that is, the pills were manipulated and left the laboratory containing on their labels only the letters S, O and F, both the researchers who will evaluate the outcomes such as participants will not know which group each participant belongs to. The patients were submitted to a raffle, where they themselves raffled one of the three letters. Therefore, the administration of L‐Citrulline was carried out in patients submitted exclusivel CONDITION: Antineoplastics; Toxicity D27.888 PRIMARY OUTCOME: Evaluate the potential of L‐citrulline for mitigating the side effects of toxicity caused by chemotherapy treatment, after supplementation for 28 days, based on the comparison of biochemical tests performed at the beginning and end of supplementation. We also want to find differences between the intervention groups and the placebo control group. SECONDARY OUTCOME: Evaluate the potential of L‐citrulline on the mitigation of renal and hepatic toxicity through supplementation in dosages developed for this purpose compared to the beginning. It is also desired to find differences between the intervention groups with the placebo control. INCLUSION CRITERIA: Patients aged 18 years or older; with a diagnosis of gastrointestinal cancer confirmed by biopsy and histological analysis; first neoplasm; under treatment for a maximum of 12 months; capable of supplementation by oral administration
Epistemonikos ID: 67dc3760acfad6b8cc0b3c6b45871c9fdd2bf767
First added on: Feb 20, 2024