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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000193

Enrollment

Registered

2008-10-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Curcumin Capsule: 8 gms/day for 28 days Control Intervention1: Curcumin Lozenges: 400 mg/day for 28 days

Eligibility

Inclusion criteria

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 &#8805; 150 x 109 /L ? Hemoglobin &#8805; 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 &#8804; 5.0 times upper limit of normal ? Negative Pregnancy test (female patients of childbearing potential only)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 2. To evaluate the pharmacokinetics and bioavailability of the topical (lozenge) and oral form of curcumin 3. To evaluate the clinical response in these patientsTimepoint: Baseline, Day 15 and Day 28	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr. Anul D'Cruz

Principal Investigator

adcruz@vsnl.com022- 24177000

Outcome results