Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- wound healing
研究概览
简要总结
using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
open labelled
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
control group
patients in this group will not having any interventions except the usual treatment before and after surgery
zinc group
patients in this group will take 50 mg zinc sulfate beside the usual treatment
干预措施: Zinc Acetate 50 Mg Oral Capsule (Dietary Supplement)
zinc and probiotics proup
patients in this group will take zinc and probiotics beside the usual treatment
干预措施: Zinc Acetate 50 Mg Oral Capsule (Dietary Supplement)
zinc and probiotics proup
patients in this group will take zinc and probiotics beside the usual treatment
干预措施: Probiotic (Dietary Supplement)
probiotics group
patients in this group will take probiotics beside the usual treatment
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
wound healing
时间窗: 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
时间窗: 21 days after surgery - total a month
according to john et al grading 3- 4 grade
rate of infections
时间窗: 21 days after surgery - a month total
rate of infection of wound after total /partial laryngectomy
starting of oral feeding
时间窗: 21 days after surgery-30 days total
reconstruction of pharynx post operative and start oral feeding
次要结局
- length of hospital stay(month from start , 21 days after surgery)
- 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)