Condition category
Cancer
Date applied
30/10/2017
Date assigned
11/11/2017
Last edited
10/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Curcumin is the active ingredient in turmeric extract and can be used as a dietary supplement known for its anti-inflammatory (swelling) behaviour. It may be beneficial for patients undergoing radiotherapy or chemoradiotherapy for cancers affecting the head and neck. Radiotherapy uses high energy rays to destroy cancer cells. Chemoradiotherapy is a combination of radiation and chemotherapy medications together. It is thought that curcumin capsules could help reduce mucositis (a painful inflammation of the membranes in the digestive tract that is an adverse impact of radiotherapy). The aim of this study is to find out the benefit of administering curcumin capsule in patients receiving radiotherapy or chemoradiotherapy for cancers affecting head and neck.

Who can participate?
Adults aged 30-90 years old who are undergoing radiotherapy for head and neck squamous cell carcinoma.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive 500mg of curcumin three times a day until they complete their radiotherapy. Those in the second group receive a placebo until the completion of radiotherapy. Participants are followed up to measured their tumour response and for any side effects.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. There is a slight risk of mild gastritis.

Where is the study run from?
R.L.Jalappa Hospital and Research Centre (India)

When is the study starting and how long is it expected to run for?
December 2012 to June 2014

Who is funding the study?
1. R. L. Jalappa Hospital and Research Centre (India)
2. Arjuna Natural Extracts Limited (India)

Who is the main contact?
Dr Arun P

Trial website

Contact information

Type

Scientific

Primary contact

Dr Arun P

ORCID ID

Contact details

Department of Otorhinolaryngology and Head and Neck Surgery
R.L.Jalappa Hospital and Research Centre
Tamaka
Kolar- 563101
Karnataka
Kolar Karnataka
563101
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SDUMC/ORLHNS/12P44002

Study information

Scientific title

Efficacy of curcumin as a radio-sensitiser and in minimising mucosal damage in patients receiving radiotherapy for head and neck squamous cell cancers

Acronym

Study hypothesis

To find out the Efficacy of Curcumin as a Radiosensitiser and in minimizing mucosal damage in patients receiving radiotherapy for head and neck squamous cell cancers.

Ethics approval

Ethical committee of Sri Devaraj Urs Medical College and Research Center, 28/11/2012, ref: ECR/425/Inst/KA/2013/RR-16

Study design

Interventional single centre single blinded randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Adjunct to radiotherapy in patients with head and neck squamous cell cancer

Intervention

Detailed clinical examination are carried out and patients are staged according to AJCC 2012 TNM classification. All adult patients undergoing radiotherapy or concurrent chemo-radiotherapy for Head and Neck Squamous Cell Carcinoma are included in the study. All participants undergo biopsy for histopathological diagnosis. Other required tests are done such as: complete blood investigations, including liver and renal function tests, x-ray mandible, chest x-ray, electrocardiogram, were done. Written informed consent is taken from all the patients included in the study. Patients with Non Squamous Head and Neck cancers, not giving consent for the treatment, with severe acid-peptic disease, with distant metastasis and with recurrent tumors were excluded from the study.

All patients enrolled in the study are randomized using 4x4 block randomization. In this method four groups are made and allotted into 1,2,3,4 groups, then random numbers were generated from 1 to 4 using Research Randomizer. The patients are randomised into 2 groups - Study group (Group A) and Control group (Group B). Patients in group A received daily dose of 500mg of turmeric extract capsules thrice a day (total dose 1.5gm/day) and were asked to take after food, while patients in control group received placebo capsules thrice a day till the completion of radiotherapy. The patients started consuming the capsules on the first day of radiation till the completion of radiotherapy.

The turmeric extract (Biocurcumax, Arjuna Natural Extracts Ltd) contains 500mg of curcuminoid complex in powder form in hard gelatin capsule which is approved by FSSAI (Food Safety and Standards Authority of India) as a nutraceutical. The matching placebo capsule contained starch powder.

All the patients receive one fraction (2Gy) of radiotherapy per day, five times a week, for a total dose of 66 Gy, spinal cord was excluded after 46Gy. Patients planned for Chemoradiation received Cisplatin infusion (50mg/m2) weekly along with radiotherapy. They remain as inpatients during their entire course of treatment and a constant check was kept on their dental, medical parameters and supportive care was given to subjects of both the arms. Patients are asked to maintain a good oral hygiene.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Tumor response is measured using the RECIST criteria using contrast enhanced computerized tomography (CECT) scan at three months
2. Effect of curcumin on oral mucositis is measured using the NCI-CTAE and WHO criteria for mucositis on a weekly basis during treatment and 2 months after treatment for subjective and Objective Assessment respectively

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

01/12/2012

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients undergoing radiotherapy or concurrent chemo-radiotherapy for Head and Neck Squamous Cell Carcinoma
2. Aged 30- 90 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64

Participant exclusion criteria

1. Patients with Non Squamous Head and Neck cancers, patients not giving consent for the treatment
2. Patients with severe acid-peptic disease
3. Patients with distant metastasis
4. Patients with recurrent tumors

Recruitment start date

10/12/2012

Recruitment end date

01/01/2014

Locations

Countries of recruitment

India

Trial participating centre

R.L.Jalappa Hospital and Research Centre
Department of Otorhinolaryngology and Head and Neck Surgery R.L.Jalappa Hospital and Research Centre Tamaka Karnataka
Karnataka
563101
India

Sponsor information

Organisation

Sri Devaraj Urs Medical College

Sponsor details

R.L.Jalappa Hospital and Research Centre
Tamaka
Kolar- 563101
Karnataka
Kolar
563101
India

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

R. L. Jalappa Hospital and Research Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Arjuna Natural Extracts Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Arun.P, Email : docarunkmc@gmail.com

Intention to publish date

30/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes