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using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | patients in this group will not having any interventions except the usual treatment before and after surgery | |
| zinc group | Active Comparator | patients in this group will take 50 mg zinc sulfate beside the usual treatment |
|
| probiotics group | Active Comparator | patients in this group will take probiotics beside the usual treatment |
|
| zinc and probiotics proup | Active Comparator | patients in this group will take zinc and probiotics beside the usual treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Acetate 50 Mg Oral Capsule | Dietary Supplement | zinc suppose to improve immunity and wound healing after laryngectomy |
|
| 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 |
| 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. |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| botamina nabil | pharmacy ASU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university hospital | Cairo | Al Abbasya | 11252 | Egypt |
until the reaserch would be complete
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Model Description
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open labelled
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| Probiotic | Dietary Supplement | probiotics lowering infections rates and improving outcomes after surgery |
|
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 |
| ID | Term |
|---|---|
| D007822 | Laryngeal Neoplasms |
| ID | Term |
|---|---|
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019345 | Zinc Acetate |
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019342 | Acetic Acid |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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