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

Ain Shams University

Status: Active, not recruiting

Conditions: Laryngectomy

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT06674564

zn probiotics laryngeal cancer

Details and patient eligibility

About

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

Full 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

Enrollment: 140 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

control group

No Intervention group

Description:

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

zinc group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule

probiotics group

Active Comparator group

Description:

patients in this group will take probiotics beside the usual treatment

Treatment:

Dietary Supplement: Probiotic

zinc and probiotics proup

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule

Dietary Supplement: Probiotic