Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery to Improve Prognosis and Better Wound Healing
- Conditions
- Laryngectomy
- Registration Number
- NCT06674564
- Lead Sponsor
- Ain Shams University
- Brief Summary
using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.
- Detailed Description
Zinc supplementation decrease plasma levels of oxidative stress markers, inflammatory cytokines and IL6. Low Serum zinc level was believed to influence the survival of laryngeal cancer patients and hence,using zinc supplementation would improve survival.Zinc help in increasing wound healing as involve in membrane repair, decreasing oxidative stress , coagulation , suppressing inflammation and modulating .Probiotics stimulates epithelial cells to release interleukin 6 (IL-6) and stimulates dendritic cells and macrophages that help in releasing TNF-α and IFN-γ , development IgA B lymphocytes that cause increase production of IgM, IgG and IgE antibodies.using probiotics preoperative or post-operative offer good chance for decreasing morbidity , infection rates , abuse of antibiotics and complications. zinc and probiotic suppose to provide better wound healing low incidence of infections and fistula after total and partial laryngectomy
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- All patients presenting to ENT department will be subjected eligible Adults patients newly diagnosed at outpatient clinic with laryngeal cancer at any stage and will undergo total/partial laryngectomy surgery.
Patients with Level of hemoglobin >9 mg/dl and serum albumin 3g/dl According to (Crosetti et al. 2021).
Staging of laryngeal cancer according to the American Joint Committee on Cancer (AJCC) 8th edition by TNM system.
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- Impaired renal function sr.cr≤2.5 (zinc clearance). 2.Previous history of cancer diseases in other sites( previous chemotherapy or radiation).
3.Hypersensitivity to probiotics and zinc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method starting of oral feeding 21 days after surgery-30 days total reconstruction of pharynx post operative and start oral feeding
wound healing 21 days after surgery, a month total The role of zinc and probiotics supplementations on the rate of wound healing (pharyngeal reconstruction.
occurrence of percutaneous fistula 21 days after surgery - total a month according to john et al grading 3- 4 grade
rate of infections 21 days after surgery - a month total rate of infection of wound after total /partial laryngectomy
- Secondary Outcome Measures
Name Time Method length of hospital stay month from start , 21 days after surgery length of hospital stay (hospital discharge)
evaluation of safety of probiotics and zinc supplementations in adults patients after total/ partial laryngectomy in terms of adverse drug events. 21-days post surgery month total evaluation of safety of probiotics and zinc supplementations in adults patients after total/ partial laryngectomy in terms of adverse drug events.
Trial Locations
- Locations (1)
Ain shams university hospital
🇪🇬Cairo, Al Abbasya, Egypt
Ain shams university hospital🇪🇬Cairo, Al Abbasya, Egypt