Status:
COMPLETED
Adjunctive Treatments for the Prevention of Radiotherapy-Induced Mucositis
Lead Sponsor:
Beni-Suef University
Collaborating Sponsors:
Sohag University
Conditions:
Radiotherapy Side Effect
Mucositis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 i...
Detailed Description
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 w...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 to 2 and normal hematologic and biochemical parameters.
Exclusion
- patients undergoing previous radiotherapy
- uncontrolled systemic or widely disseminated disease
- having any physical or mental abnormality,
- pregnant and lactating women
- presence of a synchronous double primary malignancy or simultaneous participation in another clinical trial
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06117904
Start Date
January 1 2024
End Date
July 1 2024
Last Update
July 25 2024
Active Locations (1)
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1
Asmaa Abdelfattah Elsayed
Banī Suwayf, Egypt, 82511