An invivo study to evaluate the role of curcumin in oral pre-malignant lesions and gingivo-buccal cancers

Phase 2

Registration Number: CTRI/2008/091/000193

Lead Sponsor: DBT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 90

Inclusion Criteria

? Age > 18 years
? Histologically confirmed resectable oral cavity cancer (T3, T4a) with a co-existent premalignant condition i.e. leukoplakia or submucous fibrosis.
? Gives informed consent
? Previously untreated
? WHO performance status of < 1
? Laboratory values (performed within 14 days prior to administration of Curcumin)
? WBC count > 3.0 x 109 /L
? Platelet count ≥ 150 x 109 /L
? Hemoglobin ≥ 10 gm/dl (100 gm/l)
? Serum creatinine less than 1.5 times the upper normal limit
? Total bilirubin less than 1.5 times the upper normal limit
? SGOT or SGPT ≤ 5.0 times upper limit of normal
? Negative Pregnancy test (female patients of childbearing potential only)

Exclusion Criteria

? The patient is < 18 years or >75 years of age
? The patient has had chemotherapy, immunotherapy, hormonal therapy, or radiation therapy within 4 weeks of the baseline visit
? The patient will need concurrent chemotherapy, radiotherapy, hormonal (other than HRT for menopause), or immunotherapy during the time of study
? The patient has history of any form of cancer within the past three years (excluding non-melanoma skin cancer and in situ cervical cancer)
? The patient has received any investigational medication within 30 days of starting the curcumin therapy
? The patient is participating in any other study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To determine modulation of biologic endpoints (COX-2, PGE-2, Ki67, p53, bcl2 and antiphospho-NFkB p65) in both premalignant lesions and invasive cancers<br>2. To evaluate the pharmacokinetics and bioavailability of the topical (lozenge) and oral form of curcumin<br>3. To evaluate the clinical response in these patientsTimepoint: Baseline, Day 15 and Day 28

Secondary Outcome Measures