Clinical trial NCT06674564: Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery to Improve Prognosis and Better Wound Healing
Official title: Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Laryngectomy
Keywords: laryngeal cancer , zinc , probiotics, total laryngectomy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Model Description
Primary purpose: PREVENTION

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

Eligibility criteria: 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 \&gt;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.

Primary outcomes:
measure: wound healing
timeFrame: 21 days after surgery, a month total
measure: occurrence of percutaneous fistula
timeFrame: 21 days after surgery - total a month
measure: rate of infections
timeFrame: 21 days after surgery - a month total
measure: starting of oral feeding
timeFrame: 21 days after surgery-30 days total
Secondary outcomes:
measure: length of hospital stay
timeFrame: month from start , 21 days after surgery
measure: evaluation of safety of probiotics and zinc supplementations in adults patients after total/ partial laryngectomy in terms of adverse drug events.
timeFrame: 21-days post surgery month total
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospital
state: Al Abbasya
Study officials:
affiliation: pharmacy ASU
name: botamina nabil
role: PRINCIPAL_INVESTIGATOR
References: