The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer (CurChexia)

March 27, 2023 updated by: Phramongkutklao College of Medicine and Hospital

A Double-blind, Placebo-controlled Randomized Trial Phase II Evaluating the Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer

A study of Curcumin to prevent cancer anorexia and cachexia Syndrom in locally advance and advance stage head and neck cancer (stage III, IV)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400'
        • Phramongkutklao Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Head and neck cancer stage III-IV
  • Cancer anorexia cachexia syndrome by 2011 Cancer cachexia an International Consensus
  • Enteral feeding with Nasogastric Tube or Gastrostomy
  • ECOG 0-2
  • Normal Bone marrow, kidneys, and liver function
  • Normal function of enteral digestion and absorption

Exclusion Criteria:

  • Pregnancy
  • History of allergy to Curcumin or herbal medicine
  • History of Herbal medicine used
  • History of Billiary of obstruction
  • History of Antiplatelete or anticoagulant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curcumin
Curcumin 4000mg/day x 60 days
Dietary supplement: Curcumin
We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.
Placebo Comparator: Placebo
Placebo x 60 days
Other: Placebo
We give a control arm to consume placebo for 60 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle mass
Time Frame: 60 days after intervention
We measure muscle mass by Bioelectrical Impedance Analysis (BIA)
60 days after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: 60 days after intervention
We measure BMI by Bioelectrical Impedance Analysis (BIA)
60 days after intervention
Hand grips muscle strength
Time Frame: 60 days after intervention
We measure hand grips power by Hand grip test
60 days after intervention
serum NF-kB level
Time Frame: 60 days after intervention
We measure serum NF-kB by ELISA
60 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phramongkutklao College of Medicine and Hospital

Investigators

  • Principal Investigator: Tawasapon Thambamroong, MD, Phramongkutklao College of Medicine and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2020

Primary Completion (Actual)

February 24, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R119h/61

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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