eucine supplementation in cancer patients and its effect on inflammatio

Phase 1

• Conditions: Weight loss; Muscle strength; Body composition; Inflammation

• Registration Number: RBR-7m3rvth
• Lead Sponsor: Márcia Fábia Andrade Santos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-16
• Study Completion: 2022-07-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with head and neck cancer (CCP) histologically confirmed by biopsy and pathological anatomy, with weight loss above 5% in the last 12 months or body mass index (BMI) less than 20 kg/m²

Exclusion Criteria

Obesity (BMI equal or greater than 30kg/m²); preexisting inflammatory diseases; autoimmune diseases; chronic use of anti-inflammatory drugs and/or steroids; unbalanced diabetes mellitus; use of protein supplements; regular physical activity; use of probe for feeding.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate whether leucine supplementation in patients with head and neck cancer can attenuate protein catabolism and weight loss, through densitometry and bioimpedance, as well as to evaluate the effect of supplementation on modulating the expression of inflammatory factors through the method of serum cytokine analysis. For verification, p less than 0.05 will be considered statistically significant and pre- and post-intervention parameters will be evaluated.

Secondary Outcome Measures

Name	Time	Method
Evaluate the nitrogen balance through the analysis of urinary urea and protein intake calculated by the food recall. To analyze the quality of life through questionnaires validated for the population. For verification, p less than 0.05 will be considered statistically significant and pre- and post-intervention parameters will be evaluated.