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

NCT ID: NCT06674564

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-09

Study Completion Date

2026-10-31

Brief Summary

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

Detailed Description

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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

Conditions

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Laryngectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Model Description
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

open labelled

Study Groups

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control group

patients in this group will not having any interventions except the usual treatment before and after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

zinc group

patients in this group will take 50 mg zinc sulfate beside the usual treatment

Group Type ACTIVE_COMPARATOR

Zinc Acetate 50 Mg Oral Capsule

Intervention Type DIETARY_SUPPLEMENT

zinc suppose to improve immunity and wound healing after laryngectomy

probiotics group

patients in this group will take probiotics beside the usual treatment

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

probiotics lowering infections rates and improving outcomes after surgery

zinc and probiotics proup

patients in this group will take zinc and probiotics beside the usual treatment

Group Type ACTIVE_COMPARATOR

Zinc Acetate 50 Mg Oral Capsule

Intervention Type DIETARY_SUPPLEMENT

zinc suppose to improve immunity and wound healing after laryngectomy

Probiotic

Intervention Type DIETARY_SUPPLEMENT

probiotics lowering infections rates and improving outcomes after surgery

Interventions

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Zinc Acetate 50 Mg Oral Capsule

zinc suppose to improve immunity and wound healing after laryngectomy

Intervention Type DIETARY_SUPPLEMENT

Probiotic

probiotics lowering infections rates and improving outcomes after surgery

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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botamina nabil

Role: PRINCIPAL_INVESTIGATOR

pharmacy ASU

Locations

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Ain shams university hospital

Cairo, Al Abbasya, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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zn probiotics laryngeal cancer

Identifier Type: -

Identifier Source: org_study_id

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