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| Name | Class |
|---|---|
| Sohag University | OTHER |
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Radiation therapy (RT) is used in at least 50% of cancer patients and is critical in treating and palliating tumor-related symptoms. Normal tissue radiation toxicity remains an overwhelming obstacle in treating cancer patients with localized tumors.
Mucositis is the inflammation and ulceration of the oral and gastrointestinal mucosa observed with different cancer therapies. Oral mucositis is a common, severe, and debilitating complication of RT occurring several days to weeks after RT initiation.
This study is a single blind randomized controlled clinical trial with a parallel-group design conducted in the clinical oncology department of Beni-Suef University Hospital.
A total of 50 patients with head and neck cancer receiving RT were randomly assigned into either study group:
Group 1 (Intervention group):
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks
Group 2 (Control group):
This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks.
These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets)
Grade 2 Moderate; minimal, local or noninvasive intervention indicated. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEBO ointment + symptomatic therapy | Experimental | This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks. |
|
| symptomatic therapy | Active Comparator | This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks. These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEBO ointment | Drug | This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral mucositis Severity | Oral mucositis severity was measured by the World Health Organization Toxicity Scale (WHO grading system) Grade 1 Mild; asymptomatic Grade 2 Moderate; minimal, local inflammation Grade 3 Severe or medically significant Grade 4 Life-threatening Grade 5 Death | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dry mouth, Dysphagia score | Dry mouth, Dysphagia was measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Grade 1: Symptomatic, able to eat regular diet Grade 2: Symptomatic and altered eating/swallowing Grade 3: Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Engy Wahsh | 6october University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asmaa Abdelfattah Elsayed | Banī Suwayf | 82511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16080176 | Background | Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324. | |
| 15977916 | Background | Saadeh CE. Chemotherapy- and radiotherapy-induced oral mucositis: review of preventive strategies and treatment. Pharmacotherapy. 2005 Apr;25(4):540-54. doi: 10.1592/phco.25.4.540.61035. |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Symptomatic treatment only | Drug | This group included twenty-five patients given symptomatic therapy 3 times daily for 7 weeks. These therapies included anti-fungal agents (Miconaz oral gel), topical anesthetics and anti-inflammatory drugs (BBC oral spray), topical analgesic gel (Oracure gel), sodium bicarbonate mouthwash (Alkamisr sachets). |
|
| 7 weeks |
| Discomfort and pain severity | Discomfort and pain severity were recorded using the Numeric Rating Scale (NRS) Grade 1: Mild pain Grade 2: Moderate pain Grade 3: Severe pain | 7 weeks |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |