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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208334
Recruitment Status : Recruiting
First Posted : December 23, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Phramongkutklao College of Medicine and Hospital

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

Condition or disease Intervention/treatment Phase
Cancer Cachexia Head and Neck Cancer Head and Neck Neoplasms Dietary Supplement: Curcumin Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

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.




Primary Outcome Measures :
  1. Muscle mass [ Time Frame: 60 days after intervention ]
    We measure muscle mass by Bioelectrical Impedance Analysis (BIA)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208334


Contacts
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Contact: Tawasapon Thambamroong, MD 66944699145 T.thambamroong@pmk.ac.th

Locations
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Thailand
Phramongkutklao Hospital Recruiting
Ratchathewi, Bangkok, Thailand, 10400`
Contact: Tawasapon Thambamroong, MD    6627633325    t.thambamroong@pmk.ac.th   
Sub-Investigator: Naiyarat Prasongsuk, MD         
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Investigators
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Principal Investigator: Tawasapon Thambamroong, MD Phramongkutklao College of Medicine and Hospital
Publications of Results:
Srivastava DS, Dhaulakhandi DB. Role of NF-KB in Loss of Skeletal Muscle Mass in Cancer Cachexia and its Therapeutic Targets. AJCB. 2013;1(1):16.

Other Publications:

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Responsible Party: Phramongkutklao College of Medicine and Hospital
ClinicalTrials.gov Identifier: NCT04208334    
Other Study ID Numbers: R119h/61
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phramongkutklao College of Medicine and Hospital:
Cancer cachexia
Head and neck cancer
Curcumin
Tumuric
Cancer anorexia cachexia
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Wasting Syndrome
Anorexia
Cachexia
Neoplasms by Site
Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action