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

Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery

using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.

Study Overview

• Status: Active, not recruiting
• Conditions: Laryngectomy
• Intervention / Treatment: Dietary supplement: Zinc Acetate 50 Mg Oral Capsule; Dietary supplement: Probiotic

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Abbasya
    • Cairo, Al Abbasya, Egypt, 11252
      • Ain Shams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; patients in this group will not having any interventions except the usual treatment before and after surgery
Active Comparator: zinc group; patients in this group will take 50 mg zinc sulfate beside the usual treatment	Dietary supplement: Zinc Acetate 50 Mg Oral Capsule; zinc suppose to improve immunity and wound healing after laryngectomy
Active Comparator: probiotics group; patients in this group will take probiotics beside the usual treatment	Dietary supplement: Probiotic; probiotics lowering infections rates and improving outcomes after surgery
Active Comparator: zinc and probiotics proup; patients in this group will take zinc and probiotics beside the usual treatment	Dietary supplement: Zinc Acetate 50 Mg Oral Capsule; zinc suppose to improve immunity and wound healing after laryngectomy; Dietary supplement: Probiotic; probiotics lowering infections rates and improving outcomes after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
wound healing	The role of zinc and probiotics supplementations on the rate of wound healing (pharyngeal reconstruction.	21 days after surgery, a month total
occurrence of percutaneous fistula	according to john et al grading 3- 4 grade	21 days after surgery - total a month
rate of infections	rate of infection of wound after total /partial laryngectomy	21 days after surgery - a month total
starting of oral feeding	reconstruction of pharynx post operative and start oral feeding	21 days after surgery-30 days total

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of hospital stay	length of hospital stay (hospital discharge)	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.	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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: botamina nabil, pharmacy ASU

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: laryngeal cancer , zinc , probiotics, total laryngectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Head and Neck Neoplasms; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Laryngeal Neoplasms
• Other Study ID Numbers: zn probiotics laryngeal cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: until the reaserch would be complete

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No