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Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery to Improve Prognosis and Better Wound Healing

Not Applicable
Active, not recruiting
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
Inclusion Criteria
  • 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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Exclusion Criteria
    1. 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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
starting of oral feeding21 days after surgery-30 days total

reconstruction of pharynx post operative and start oral feeding

wound healing21 days after surgery, a month total

The role of zinc and probiotics supplementations on the rate of wound healing (pharyngeal reconstruction.

occurrence of percutaneous fistula21 days after surgery - total a month

according to john et al grading 3- 4 grade

rate of infections21 days after surgery - a month total

rate of infection of wound after total /partial laryngectomy

Secondary Outcome Measures
NameTimeMethod
length of hospital staymonth 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
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