Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06674564

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university hospital

Cairo, Al Abbasya, 11252, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc Acetate 50 Mg Oral Capsule

Dietary Supplement

zinc suppose to improve immunity and wound healing after laryngectomy

Probiotic

Dietary Supplement

probiotics lowering infections rates and improving outcomes after surgery

Primary outcomes

  1. wound healing

    Time frame: 21 days after surgery, a month total

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

  2. occurrence of percutaneous fistula

    Time frame: 21 days after surgery - total a month

    according to john et al grading 3- 4 grade

  3. rate of infections

    Time frame: 21 days after surgery - a month total

    rate of infection of wound after total /partial laryngectomy

  4. starting of oral feeding

    Time frame: 21 days after surgery-30 days total

    reconstruction of pharynx post operative and start oral feeding

Secondary outcomes

  1. length of hospital stay

    Time frame: month from start , 21 days after surgery

    length of hospital stay (hospital discharge)

  2. evaluation of safety of probiotics and zinc supplementations in adults patients after total/ partial laryngectomy in terms of adverse drug events.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.