Phase II/III Randomized Placebo Controlled Clinical Trial of Curcumin in Resectable Stage III and IV Squamous Head and Neck Cancers (Oral cancers)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000195

Enrollment

160

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: 3.6 gms/day for 6 months Control Intervention1: Placebo Capsule: 3.6 gms/day for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed squamous cancers of oral cavity 2. Stage III-IV (resectable lesions) 3. Karnofsky?s scale > 60% 4. Patients selected to undergo curative treatment (otherwise generally fit patients) 5. Patient has signed and dated the Informed Consent Document 6. Patient is willing and able to fully participate for the duration of the study

Exclusion criteria

Exclusion criteria: 1. All patients with unresectable lesions 2. Poor Karnofsky?s scale 3. Patients with non-squamous cancers. 4. Patients who does not comply with assigned complete treatment protocol. 5. Patients with potential behavior and cognitive impairment.

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of curcumin in subjects with histologically proven resectable stage III and IV squamous cancers of the head and neck (to monitor the rate of failure / recurrences) following standard treatment Timepoint: Baseline, 24 hrs, 7 days & 6 months for estimation of curcumin. For rate of failure/recurrence: every 2 months for 6 months and thereafter every 2 months till recurrence or upto 2 years.	—

Measure

Time frame

To determine the efficacy of curcumin in subjects with histologically proven resectable stage III and IV squamous cancers of the head and neck (to monitor the rate of failure / recurrences) following standard treatment Timepoint: Baseline, 24 hrs, 7 days & 6 months for estimation of curcumin. For rate of failure/recurrence: every 2 months for 6 months and thereafter every 2 months till recurrence or upto 2 years.

—

Secondary

Measure	Time frame
To evaluate curcumin induced modulation of biomarkers -COX-2/PGE2 -IL-6 Timepoint: Baseline, 24 hrs, 7 days & 6 months	—

Countries

India

Contacts

Public ContactDr. Alok Thakar

Principal Investigator

drathakar@gmail.com011-26593492

Outcome results