OncologyNCT06100692
Prophylactic Oral Vitamin D and Zinc for Radiation-Induced Oral Mucositis in Head and Neck Cancer
An observational study of Oncology, run by Assiut University.
Trial summary
The main aim of this study was to evaluate clinically the effect of a combination between oral vitamin D and oral zinc in comparison to conventional therapy in prevention of radiotherapy-induced oral mucositis in Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: maternal and perinatal morbidity and mortality
Who may be able to join
- Selection of patients
- All adults (18 years or older ), who were confirmed based on pathology ( Head and Neck Squamous Cell Carcinomas ), will administere chemo-radiotherapy either as preoperative (neoadjuvant), postoperative (adjuvant) therapy or definitive therapy, no randomization .
- The treatment group will receive combined oral Vit D and Zinc and the control group will take placebo capsules or receive no treatment.
- No documentation of any other causes of oral mucositis in their medical records as : immunocomprmized patients d.t HIV
Who cannot join
- Non Head and Neck cancer
- patients with any other causes of oral mucositis
- Double malignancy
- Un eligible patients for radiotherapy ( comatosed, bedridden and sever chest disease )
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Prophylactic Use of Oral Vitamin D and Zinc in Management of the Severity of Radiation Induced Oral Mucositis of Head and Neck Cancer Patients
The main aim of this study was to evaluate clinically the effect of a combination between oral vitamin D and oral zinc in comparison to conventional therapy in prevention of radiotherapy-induced oral mucositis in Assiut University Hospitals.
Read the detailed description
Most head and neck cancers are derived from the mucosal epithelium in the oral cavity, pharynx and larynx and are known collectively as head and neck squamous cell carcinoma (HNSCC). Oral cavity and larynx cancers are generally associated with tobacco consumption, alcohol abuse or both, whereas pharynx cancers are increasingly attributed to infection with human papillomavirus (HPV), primarily HPV-16. Thus, HNSCC can be separated into HPV-negative and HPV-positive HNSCC.
As a major histological type of HNC, head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide. Totally, 53,000 new cases and 10,860 HNC-related deaths were observed in the U.S. in 2019. According to the estimation of the World Health Organization, 439,000 mouth and oropharynx cancer will be observed in 2030.
The main treatment options are surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy.
Treatment options and recommendations depend on several factors, including the type and stage of head and neck cancer, possible side effects, and the patient's preferences and overall health.
Radiation therapy (RT) plays a key role in curative-intent treatments for head and neck cancers. Its use is indicated as a sole therapy in early stage tumors or in combination with surgery or concurrent chemotherapy in advanced stages. Recent technologic advances have resulted in both improved oncologic results and expansion of the indications for RT in clinical practice.
Chemotherapy is a treatment for head and neck cancer that uses powerful drugs to attack cancer cells. Often chemotherapy drugs are given before or during radiation to improve the effectiveness of care. Other drug therapies target the genetic mutations found in tumors or stimulate the immune system to fight the cancer.
Approximately 60% of head and neck cancer patients who were instructed to receive radiotherapy will suffer from oral mucositis. More importantly, the incidence of oral mucositis increases to 90% when patients underwent concurrent chemotherapy 19% of the latter will be hospitalized and will experience a delay in antineoplastic treatment for high-grade mucositis management.
Oral mucositis is a common side-effect associated with systemic chemotherapy and radiation of the head and neck region. It is characterized as an inflammation of the oral mucous membranes accompanied by many complex mucosal and submucosal changes. Ulcerative oral mucositis can cause significant oral pain, impair nutritional intake, lead to local or systemic infection, and cause significant economic cost. In addition, it may necessitate interruptions in cancer therapy, resulting in a reduction of the quality of life, a worse prognosis and an increase in patient management costs, thus adversely affecting patient prognosis.
vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis
Oral mucositis scale Vitamin D supplementation significantly improved erythema, lichenoid, edema, ulceration and pain in patients with inoperable/unresectable oral cancer.
Hypovitaminosis D could increase risk of developing OSCC from OPMDs, thus altering the immune response and it is associated with a lower survival rate in patients with OSCC, a greater recurrence of tumors in patients who underwent surgical treatment, and an increase in adverse reactions to chemotherapy. The use of vitamin D supplements can be a complement to primary therapy to prevent the recurrence of lesions and reduce adverse events associated with treatment.
Vitamin D supplementation has a role in reducing treatment-related toxicities, especially in advanced cancer.
Zinc sulfate is beneficial in decreasing the severity of radiation-induced mucositis and oral discomfort. These results should be confirmed by additional evaluation in randomized studies with a larger number of patients.
zinc has the potential of relieving oxidant damage and the progression of reactive oxygen species (ROS)-induced disease.
The World Health Organization has developed a grading system for mucositis based on clinical appearance and functional status.
The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
WHO Oral Mucositis Grading Scale Grade Description 0 (none) None I (mild) Oral soreness, erythema II (moderate) Oral erythema, ulcers, solid diet tolerated III (severe) Oral ulcers, liquid diet only IV (life-threatening) Oral alimentation impossible
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called zinc
the patients will receive a 30 pts a combination of oral vit D and zinc
| Study group | Role | What they receive |
|---|---|---|
| vit D and zinc group | will receive combination of oral vit D and zinc 30 patients Receives: Drug: Vitamin D | |
| placebo group | receive Placebo or no treatment 30 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral mucositis scale
The Oral Mucositis Assessment Scale (OMAS) is an objective scale that measures erythema and ulceration at nine sites within the oral cavity grade0:(none) grade1(mild): oral soreness and erythema grade 2(moderate):oral erythema ,ulcers, solid diet tolerance grade 3(sever) :liquids diet only grade 4(life threatening) oral alimentation impossible
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shorooq Mostafa Kamel Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100692
- Sponsor's protocol ID
- EPUO
- Status last verified
- Nov 2023
- First submitted
- 14 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hashim D, Sartori S, La Vecchia C, Serraino D, Maso LD, Negri E, Smith E, Levi F, Boccia S, Cadoni G, Luu HN, Lee YA, Hashibe M, Boffetta P. Hormone factors play a favorable role in female head and neck cancer risk. Cancer Med. 2017 Aug;6(8):1998-2007. doi: 10.1002/cam4.1136. Epub 2017 Jul 14.
PubMed 28707400Shuai T, Yi LJ, Tian X, Chen WQ, Chen H, Li XE. Prophylaxis with oral zinc sulfate against radiation-induced oropharyngeal mucositis in patients with head and neck cancer: Protocol for a meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13310. doi: 10.1097/MD.0000000000013310.
PubMed 30508920Rambod M, Pasyar N, Ramzi M. The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. Eur J Oncol Nurs. 2018 Apr;33:14-21. doi: 10.1016/j.ejon.2018.01.007. Epub 2018 Feb 2.
PubMed 29551172Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.
PubMed 25774860Anand A, Singh S, Sonkar AA, Husain N, Singh KR, Singh S, Kushwaha JK. Expression of vitamin D receptor and vitamin D status in patients with oral neoplasms and effect of vitamin D supplementation on quality of life in advanced cancer treatment. Contemp Oncol (Pozn). 2017;21(2):145-151. doi: 10.5114/wo.2017.68623. Epub 2017 Jun 30.
PubMed 28947884Sutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):917-30. doi: 10.1016/s0360-3016(00)01456-5.
PubMed 11240232Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7.
PubMed 33028357
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Use of Oral Vitamin D and Zinc in Management of the Severity of Radiation Induced Oral Mucositis of Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT06100692
- Acronym / sponsor ID
- EPUO
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
The main aim of this study was to evaluate clinically the effect of a combination between oral vitamin D and oral zinc in comparison to conventional therapy in prevention of radiotherapy-induced oral mucositis in Assiut University Hospitals.
Detailed description
Most head and neck cancers are derived from the mucosal epithelium in the oral cavity, pharynx and larynx and are known collectively as head and neck squamous cell carcinoma (HNSCC). Oral cavity and larynx cancers are generally associated with tobacco consumption, alcohol abuse or both, whereas pharynx cancers are increasingly attributed to infection with human papillomavirus (HPV), primarily HPV-16. Thus, HNSCC can be separated into HPV-negative and HPV-positive HNSCC.
As a major histological type of HNC, head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide. Totally, 53,000 new cases and 10,860 HNC-related deaths were observed in the U.S. in 2019. According to the estimation of the World Health Organization, 439,000 mouth and oropharynx cancer will be observed in 2030.
The main treatment options are surgery, radiation therapy, chemotherapy, targeted therapy, and immunotherapy.
Treatment options and recommendations depend on several factors, including the type and stage of head and neck cancer, possible side effects, and the patient's preferences and overall health.
Radiation therapy (RT) plays a key role in curative-intent treatments for head and neck cancers. Its use is indicated as a sole therapy in early stage tumors or in combination with surgery or concurrent chemotherapy in advanced stages. Recent technologic advances have resulted in both improved oncologic results and expansion of the indications for RT in clinical practice.
Chemotherapy is a treatment for head and neck cancer that uses powerful drugs to attack cancer cells. Often chemotherapy drugs are given before or during radiation to improve the effectiveness of care. Other drug therapies target the genetic mutations found in tumors or stimulate the immune system to fight the cancer.
Approximately 60% of head and neck cancer patients who were instructed to receive radiotherapy will suffer from oral mucositis. More importantly, the incidence of oral mucositis increases to 90% when patients underwent concurrent chemotherapy 19% of the latter will be hospitalized and will experience a delay in antineoplastic treatment for high-grade mucositis management.
Oral mucositis is a common side-effect associated with systemic chemotherapy and radiation of the head and neck region. It is characterized as an inflammation of the oral mucous membranes accompanied by many complex mucosal and submucosal changes. Ulcerative oral mucositis can cause significant oral pain, impair nutritional intake, lead to local or systemic infection, and cause significant economic cost. In addition, it may necessitate interruptions in cancer therapy, resulting in a reduction of the quality of life, a worse prognosis and an increase in patient management costs, thus adversely affecting patient prognosis.
vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis
Oral mucositis scale Vitamin D supplementation significantly improved erythema, lichenoid, edema, ulceration and pain in patients with inoperable/unresectable oral cancer.
Hypovitaminosis D could increase risk of developing OSCC from OPMDs, thus altering the immune response and it is associated with a lower survival rate in patients with OSCC, a greater recurrence of tumors in patients who underwent surgical treatment, and an increase in adverse reactions to chemotherapy. The use of vitamin D supplements can be a complement to primary therapy to prevent the recurrence of lesions and reduce adverse events associated with treatment.
Vitamin D supplementation has a role in reducing treatment-related toxicities, especially in advanced cancer.
Zinc sulfate is beneficial in decreasing the severity of radiation-induced mucositis and oral discomfort. These results should be confirmed by additional evaluation in randomized studies with a larger number of patients.
zinc has the potential of relieving oxidant damage and the progression of reactive oxygen species (ROS)-induced disease.
The World Health Organization has developed a grading system for mucositis based on clinical appearance and functional status.
The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
WHO Oral Mucositis Grading Scale Grade Description 0 (none) None I (mild) Oral soreness, erythema II (moderate) Oral erythema, ulcers, solid diet tolerated III (severe) Oral ulcers, liquid diet only IV (life-threatening) Oral alimentation impossible
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vit D and zinc group | – | Drug: Vitamin Dwill receive combination of oral vit D and zinc 30 patients |
| placebo group | – | –receive Placebo or no treatment 30 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- maternal and perinatal morbidity and mortality
Key inclusion criteria (4 listed)
- Selection of patients
Key exclusion criteria (4 listed)
- Non Head and Neck cancer
- patients with any other causes of oral mucositis
- Double malignancy
- Un eligible patients for radiotherapy ( comatosed, bedridden and sever chest disease )
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 |
|---|---|---|
| Vitamin DAlso: zincthe patients will receive a 30 pts a combination of oral vit D and zinc | Drug | vit D and zinc group |
Primary outcome
oral mucositis scale
Time frame: baseline
The Oral Mucositis Assessment Scale (OMAS) is an objective scale that measures erythema and ulceration at nine sites within the oral cavity grade0:(none) grade1(mild): oral soreness and erythema grade 2(moderate):oral erythema ,ulcers, solid diet tolerance grade 3(sever) :liquids diet only grade 4(life threatening) oral alimentation impossible
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 28707400Hashim D, Sartori S, La Vecchia C, Serraino D, Maso LD, Negri E, Smith E, Levi F, Boccia S, Cadoni G, Luu HN, Lee YA, Hashibe M, Boffetta P. Hormone factors play a favorable role in female head and neck cancer risk. Cancer Med. 2017 Aug;6(8):1998-2007. doi: 10.1002/cam4.1136. Epub 2017 Jul 14.
- Background: PubMed 30508920Shuai T, Yi LJ, Tian X, Chen WQ, Chen H, Li XE. Prophylaxis with oral zinc sulfate against radiation-induced oropharyngeal mucositis in patients with head and neck cancer: Protocol for a meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13310. doi: 10.1097/MD.0000000000013310.
- Background: PubMed 29551172Rambod M, Pasyar N, Ramzi M. The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. Eur J Oncol Nurs. 2018 Apr;33:14-21. doi: 10.1016/j.ejon.2018.01.007. Epub 2018 Feb 2.
- Background: PubMed 25774860Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.
- Background: PubMed 28947884Anand A, Singh S, Sonkar AA, Husain N, Singh KR, Singh S, Kushwaha JK. Expression of vitamin D receptor and vitamin D status in patients with oral neoplasms and effect of vitamin D supplementation on quality of life in advanced cancer treatment. Contemp Oncol (Pozn). 2017;21(2):145-151. doi: 10.5114/wo.2017.68623. Epub 2017 Jun 30.
- Background: PubMed 11240232Sutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):917-30. doi: 10.1016/s0360-3016(00)01456-5.
- Background: PubMed 33028357Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Assiut University.
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 4 inclusion and 4 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shorooq mostafa, master (01050036903, shorooqmostafa2510@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral mucositis scale (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100692, which also lists 7 linked publications.
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 7 Nov 2023.