LaryngectomyNCT06674564
Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery to Improve Prognosis and Better Wound Healing
A study testing Zinc Acetate 50 Mg Oral Capsule and Probiotic in people with Laryngectomy, run by Ain Shams University at 1 site in Egypt.
Trial summary
using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laryngectomy
- What is being tested?
- Zinc Acetate 50 Mg Oral Capsule and Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery
using zinc and probiotics supplementation for providing better prognosis for laryngeal cancer patients under going total or partial laryngectomy.
Read the 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
- Conditions
- Laryngectomy
- Being tested
- Zinc Acetate 50 Mg Oral Capsule, Probiotic
- Keywords
- laryngeal cancer , zinc , probiotics, total laryngectomy
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Acetate 50 Mg Oral CapsuleDietary supplement
zinc suppose to improve immunity and wound healing after laryngectomy
ProbioticDietary supplement
probiotics lowering infections rates and improving outcomes after surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule |
| probiotics group | Active comparator | patients in this group will take probiotics beside the usual treatment Receives: Dietary Supplement: Probiotic |
| zinc and probiotics proup | Active comparator | patients in this group will take zinc and probiotics beside the usual treatment Receives: Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule; Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing
The role of zinc and probiotics supplementations on the rate of wound healing (pharyngeal reconstruction.
Measured: 21 days after surgery, a month total
occurrence of percutaneous fistula
according to john et al grading 3- 4 grade
Measured: 21 days after surgery - total a month
rate of infections
rate of infection of wound after total /partial laryngectomy
Measured: 21 days after surgery - a month total
starting of oral feeding
reconstruction of pharynx post operative and start oral feeding
Measured: 21 days after surgery-30 days total
Secondary outcomes (2)
length of hospital stay
length of hospital stay (hospital discharge)
Measured: 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.
evaluation of safety of probiotics and zinc supplementations in adults patients after total/ partial laryngectomy in terms of adverse drug events.
Measured: 21-days post surgery month total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start9 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaryngectomyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- botamina nabil, Principal investigator, pharmacy ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674564
- Sponsor's protocol ID
- zn probiotics laryngeal cancer
- Status last verified
- Sep 2024
- First submitted
- 1 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: until the reaserch would be complete
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zinc and Probiotics Supplementation on Laryngeal Cancer Patients Undergoing Laryngectomy Surgery
- ClinicalTrials.gov ID
- NCT06674564
- Acronym / sponsor ID
- zn probiotics laryngeal cancer
- Conditions
- Laryngectomy
- Keywords
- laryngeal cancer , zinc , probiotics, total laryngectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Zinc Acetate 50 Mg Oral Capsulepatients in this group will take 50 mg zinc sulfate beside the usual treatment |
| probiotics group | Active comparator | Dietary Supplement: Probioticpatients in this group will take probiotics beside the usual treatment |
| zinc and probiotics proup | Active comparator | Dietary Supplement: Zinc Acetate 50 Mg Oral Capsule, Dietary Supplement: Probioticpatients in this group will take zinc and probiotics beside the usual treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Acetate 50 Mg Oral Capsulezinc suppose to improve immunity and wound healing after laryngectomy | Dietary supplement | zinc and probiotics proup, zinc group |
| Probioticprobiotics lowering infections rates and improving outcomes after surgery | Dietary supplement | probiotics group, zinc and probiotics proup |
Primary outcome
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.
occurrence of percutaneous fistula
Time frame: 21 days after surgery - total a month
according to john et al grading 3- 4 grade
rate of infections
Time frame: 21 days after surgery - a month total
rate of infection of wound after total /partial laryngectomy
starting of oral feeding
Time frame: 21 days after surgery-30 days total
reconstruction of pharynx post operative and start oral feeding
2 secondary outcomes
length of hospital stay
Time frame: 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.
Time frame: 21-days post surgery month total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No. until the reaserch would be complete
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
botamina nabil principal investigator
pharmacy ASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Acetate 50 Mg Oral Capsule and Probiotic in people with Laryngectomy, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing (time frame: 21 days after surgery, a month total). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.