Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06100692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-14
Brief Title:
Prophylactic Oral Vitamin D and Zinc for Radiation-Induced Oral Mucositis in Head and Neck Cancer
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 53000 new cases and 10860 HNC-related deaths were observed in the US in 2019 According to the estimation of the World Health Organization 439000 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 patients 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 calciumphosphorus balance Recently the non-calcemic roles of vitamin D as anti-inflammatory anti-oxidant and immuno-regulatory functions have been widely reportedSo 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 inoperableunresectable 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
As a major histological type of HNC head and neck squamous cell carcinoma HNSCC is the sixth most common cancer worldwide Totally 53000 new cases and 10860 HNC-related deaths were observed in the US in 2019 According to the estimation of the World Health Organization 439000 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 patients 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 calciumphosphorus balance Recently the non-calcemic roles of vitamin D as anti-inflammatory anti-oxidant and immuno-regulatory functions have been widely reportedSo 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 inoperableunresectable 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None