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A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Other | Standard Care |
|
| Interventional arm | Active Comparator | Standard Care plus NAC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetyl-Cysteine with Institutional standard care | Drug | A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis. | Difference between the two arms regarding incidence of grade ≥ 2 according to World Health Organization scale for Oral Mucositis. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to develop oral mucositis with grade ≥ 2. | Difference between the two arms regarding time to develop oral mucositis with grade ≥ 2 according to WHO scale for oral mucositis. World Health Organization scale for oral mucositis
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reem Abou-Elezz, BSc | Contact | +201065396455 | reemabouelezz@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed el-Husseiny shams, Professor | Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University | Principal Investigator |
| Noha Mansour, phD | Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Oncology and Nuclear Medicine of Mansoura University Hospital | Recruiting | Al Mansurah | Egypt |
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| Institutional standard care | Drug | Benzydamine Mouthwash |
|
| 8 weeks |
| Duration of oral mucositis with grade ≥ 2. | Difference between the two arms regarding duration of oral mucositis with grade ≥ 2 according to WHO scale for oral mucositis. | 8 weeks |
| Pain assessed by Visual Analog Scale (VAS). | The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression. The most simple VAS is a straight horizontal line of fixed length usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best). we will allocate this scale in comparing pain severity between the two arms. | 8 weeks |
| Functional oral intake scale | TUBE DEPENDENT (levels 1-3)
TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. Total oral intake with no restrictions | 8 weeks |
| Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4 | A questionnaire filled by head and neck cancer patient to assess the quality of life. H&N1 I am able to eat the foods that I like H&N2 My mouth is dry H&N3 I have trouble breathing H&N4 My voice has its usual quality and strength H&N5 I am able to eat as much food as I want H&N6 I am unhappy with how my face and neck look H&N7 I can swallow naturally and easily H&N8 I smoke cigarettes or other tobacco products H&N9 I drink alcohol (e.g. beer, wine, etc.) H&N10 I am able to communicate with others H&N11 I can eat solid foods H&N12 I have pain in my mouth, throat or neck Scoring:Not at all (0) A little bit (1) Somewhat (2) Quite a bit (3) Very much(4) | 8 weeks |
| Study Director |
| Rasha Mohamed Abd-Ellatif, Professor | Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Mansoura University | Study Director |
| Fatma Gharib Khirallah, Associate Professor | Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Tanta University | Study Director |
| Mohamed Awad Ebrahim, Professor | Center of Medical Oncology and Adult BMT, Faculty of Medicine, Mansoura University. | Study Director |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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