Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Assessing the Effects and Safety of MEBO as Add on Therapy for the Prevention of Radiotherapy-Induced Mucositis

ID
Name
BeniSuefUU
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-12-01
Trial end
2023-12-30
Status
Active (not recruiting)
Treatment
MEBO ointment
This group included twenty-five patients given Mebo ointment in combination with the symptomatic therapy 3 times daily for 7 weeks
Arms:
MEBO ointment + symptomatic therapy
Symptomatic treatment only
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).
Arms:
MEBO ointment + symptomatic therapy, symptomatic therapy
Size
60
Primary endpoint
Oral mucositis Severity
7 weeks
Eligibility criteria
Inclusion Criteria: 1. Adults (\>18 years) with histopathologically confirmed Head and Neck Cancer (HNC), primary tumor in the stages T1, T2, T3, or T4, a regional node of any N status, and distant metastases absent. 2. All patients who were going to receive RT (dose between 60-70 Gy) on the head and neck region as postoperative (adjuvant) or definitive therapy. Either these patients had received chemotherapy prior or in concomitant to radiotherapy. 3. Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2 and normal hematologic and biochemical parameters. Exclusion Criteria: 1. patients undergoing previous radiotherapy 2. uncontrolled systemic or widely disseminated disease 3. having any physical or mental abnormality, 4. pregnant and lactating women 5. presence of a synchronous double primary malignancy or simultaneous participation in another clinical trial
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-11-14

1 organization

2 products

2 indications

Organization
Beni-Suef University
Product
MEBO
Indication
Radiotherapy Side Effect
Indication
Mucositis
Product
Symptomatic treatment