Using Aloe Vera Gel and Manuka Honey to Treat Oral Mucositis from Radiation
Synergistic Effect of Aloe Vera Gel and Manuka Honey on Radiation Induced Oral Mucositis in Head and Neck Cancer Patients: Randomized Controlled Clinical Trial
This study is testing if a mix of Aloe Vera Gel and Manuka Honey can help people with head and neck cancer feel better by reducing the painful mouth sores caused by radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06381635 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Aloe Vera Gel and Manuka Honey in managing radiation-induced oral mucositis in patients undergoing treatment for head and neck cancer. Participants will apply either the Aloe Vera Gel and Manuka Honey mixture or saline three times daily during their radiotherapy and for six months afterward. The study will also assess the impact of these treatments on specific biomarkers in saliva, such as TGFβ1 and EGF. The goal is to provide a potential therapeutic option to alleviate the painful side effects of radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are patients aged 20-70 with a confirmed diagnosis of head and neck malignancy who are receiving non-palliative radiotherapy and have developed oral mucositis.
Not a fit: Patients with diabetes mellitus or those who have undergone radiotherapy within the last six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the severity of oral mucositis and improve the quality of life for patients undergoing radiation therapy.
How similar studies have performed: While the use of Aloe Vera and Manuka Honey is promising, this specific combination for radiation-induced mucositis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * a) Have a confirmed or medically treated diabetes mellitus b) Radiotherapy within the last 6 months prior to this study c) Vulnerable patients
Where this trial is running
Cairo and 1 other locations
- ain shams University — Cairo, Egypt (Recruiting)
- Fatma E.Sayed — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Fatma E. Hassanein
- Email: fatmahassanein@dent.asu.edu.eg
- Phone: +201000093885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.