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Completed

NCT Number: NCT04208334

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)

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Key information

Conditions

Cancer Cachexia Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phramongkutklao Hospital

Ratchathewi, Bangkok, 10400', Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Curcumin

Dietary Supplement

We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.

Placebo

Other

We give a control arm to consume placebo for 60 consecutive days.

Primary outcomes

  1. Muscle mass

    Time frame: 60 days after intervention

    We measure muscle mass by Bioelectrical Impedance Analysis (BIA)

Secondary outcomes

  1. BMI

    Time frame: 60 days after intervention

    We measure BMI by Bioelectrical Impedance Analysis (BIA)

  2. Hand grips muscle strength

    Time frame: 60 days after intervention

    We measure hand grips power by Hand grip test

  3. serum NF-kB level

    Time frame: 60 days after intervention

    We measure serum NF-kB by ELISA

Sponsors and collaborators

Lead sponsor

Phramongkutklao College of Medicine and Hospital

Other

Registry information

Official study title

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

Acronym: CurChexia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2019
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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