Effect of Supplementation of Poly-unsaturated n-3 Fatty Acids and High-protein Diet on Epigenetic Modulation of Muscle Mass, Dose-limiting Toxicity and Intestinal Microbiota in Patients With Lung Cancer Submitted to Treatment With Immunotherapy, Chemotherapy and Tyrosine Kinase Inhibitors.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study is conducted to test the hypothesis that patients with lung cancer undergoing treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors receiving a high protein diet and supplemented with fish oil will improve muscle mass, therapeutic response and modulate the intestinal microbiota within a 4 month period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 90
Healthy Volunteers: f
View:
• Diagnosis of non-small cell lung cancer, both sexes, ECOG performance status (0-2) eligible for treatment with immunotherapy, chemotherapy and tyrosine Kinase Inhibitors.
Locations
Other Locations
Brazil
Federal University of Rio de Janeiro
RECRUITING
Rio De Janeiro
Contact Information
Primary
Wilza AF Peres, PhD
wilza@nutricao.ufrj.br
552139386432
Backup
Imanuely B Gonçalves, MsC
imanuely.goncalves@oncoclinicas.com
552134396432
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2025-03-15
Participants
Target number of participants: 50
Treatments
Placebo_comparator: Placebo Comparator: Placebo
Placebo Comparator: Placebo All subjects will be given placebo identically matched with regard to shape, color and taste. They will be given four tablet/day for four mounths.
Experimental: Experimental: Fish oil
All subjects will be given fish oil with a dose of 2.100 mg of EPA and 924 mg of DHA, in four tablet twice daily for four mounths.
Related Therapeutic Areas
Sponsors
Collaborators: Oncoclínicas, Institutos Madrileño de Estudios Avanzados IMDEA
Leads: Universidade Federal do Rio de Janeiro