Title: Effect of Curcumin on Radiation induced Oral Mucositis

Principal Investigator:

Dr. Tej Prakash Soni (Consultant, Dept. Of Radiotherapy, BMCHRC, Jaipur)

Aims and Objectives:

To determine whether supplementation of curcumin reduces the severity of Oral Mucositis in patients receiving radiotherapy for Oral Cancers

Introduction:

Oral mucositis refers to the oral erythematous and ulcerative lesions commonly observed in patients undergoing cancer therapy. Oral Mucositis is one of the most common adverse reactions of radiation therapy for head and neck cancers. It compromises patient’s nutritional status, quality of life and contributes local and systemic infections. Mucositis may limit the patient’s ability to tolerate full course of radiation therapy and chemotherapy. Between 30% and 60% of patients receiving radiation therapy for cancer of the head and neck may develop oral mucositis, and greater than 90% of patients receiving concomitant chemotherapy. Currently, no intervention that is completely successful at preventing oral mucositis exists. Oral Mucositis management includes Granulocyte colony-stimulating factor (G-CSF), Amifostine, Antibiotics, Antifungals, Topical Coating Agents like Sucralfate, Antiinflammatory agents like Benzydamine HCL and maintaining good oral Hygiene.

Curcumin, a commonly-used spice (turmeric) in India and Southeast Asia, was shown in animal models to prevent chemotherapy and radiotherapy induced mucositis. It has proven properties like anti-inflammatory, antioxidant, antimicrobial, hepatoprotective, immunostimulant, antiseptic, and antimutagenic.

We hypothesize that curcumin may prevent oral mucosal injury and reduce the severity of oral mucositis in patients receiving radiotherapy for oral cancer.

Material and Method:

With the informed consent, 60 patients of postoperative Oral Squamous cell carcinoma will be randomly allocated equally in three arms: Arm A-Curcumin 1000 mg per day, Arm B-Curcumin 1500 mg per day, Arm C: Placebo during the course of radiotherapy.

Radiotherapy alone will be initiated within 4–6 weeks after operation using 6 MV photons with daily fractions of 1.8 or 2 Gy on 5 consecutive days per week. After Orifit thermoplastic immobilisation mask preparation in supine position, contrast enhanced CT scans with 3-5 mm slice thickness will be done for treatment planning. Radiotherapy planning will be done on Eclipse or Oncentra TPS. Radiotherapy Dose prescription will be 60 Gy in 30 fractions, five fractions in a week for 6 weeks.

All patients will be assessed weekly during radiotherapy. Oral mucositis will be assessed with use of the World Health Organization (WHO) scale, the Oral Mucositis Assessment Scale (OMAS), CTCAE v4.0, and a Visual Analog pain scale (VAS; patient reporting scale of 0–10).

Sample Size: 60 patients

Patient Selection Criteria:

Inclusion Criteria:

• Post surgical resection cases of Carcinoma Buccal Mucosa, Gingiva/Alveolus, Retromandibular Trigone, Oral Tongue, Lips, Floor of Mouth, Hard Palate
• Histology proven Squamous cell carcinoma
• Age >18 years to <70 years
• WHO Performance Status 0-1
• No prior history of Radiotherapy to head neck region

Exclusion Criteria:

·       Primary Site of Oropharynx, Nasopharynx, Larynx

·       History of previous Radiotherapy to head neck region

·       Histopathology other than squamous cell carcinoma