Synergistic Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis in Head and Neck Cancer Patients: Randomized Controlled Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Aloe Vera Gel and Manuka Honey in management of Radiation Induced Mucositis in head and neck cancer patients. The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are: 1. Is Aloe Vera Gel and Manuka Honey effective in management of Radiation Induced Mucositis? 2. Does Aloe Vera Gel and Manuka Honey affect the level of TGFβ1 and EGF in saliva of patients with radiation induced mucositis? participants will be asked to apply Aloe Vera Gel and Manuka Honey or saline three times daily during radiotherapy and 6 months after radiotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

• a) Patients with a confirmed histologic diagnosis of H\&N malignancy who are referred to non-palliative radiotherapy in the oral cavity.

• b) Patient who is receiving radiation therapy with IMRT or 3D techniques. c) Patients received 50-70 Gy of total radiation at the rate of 2 Gy/fraction daily and 5 fractions/week.

• d) Patient who received concurrent chemotherapy with radiotherapy e) Presence of Oral Mucositis f) Age 20-70 years old g) Willing to participate in the study. h) Able to complete the study assessments.

Locations
Other Locations
Egypt
ain shams University
RECRUITING
Cairo
Fatma E.Sayed
RECRUITING
Cairo
Contact Information
Primary
Fatma E. Hassanein
fatmahassanein@dent.asu.edu.eg
+201000093885
Backup
Asma A. Abou Bakr, PHD
Asmaa.Aboubakr@bue.edu.eg
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 40
Treatments
Experimental: intervention group
patients will be given 20 mL of Manuka honey with aloe vera gel, 15 min before and after the radiotherapy. They were instructed to swallow slowly to smear the layer of honey on the oral and pharyngeal mucosa. Patients were also advised to take 20 mL of Manuka honey before sleeping in the night. This treatment protocol was followed from day 1 of radiation till 6 weeks.
Placebo_comparator: Control group
patients will be given 20 mL of 0.9% of saline 15 min before and after radiotherapy \[54\]. They will be advised to rinse saline. They will be instructed to keep saline for at least 5 min duration and then to spit it out. They will be advised to rinse 20 mL of saline in the same manner before sleeping. This treatment protocol was followed from day 1 of radiation till 6 weeks.
Related Therapeutic Areas
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov