Clinical trial NCT04208334: The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Cachexia
Head and Neck Cancer
Head and Neck Neoplasms
Keywords: Cancer cachexia
Head and neck cancer
Curcumin
Tumuric
Cancer anorexia cachexia
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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)


Eligibility 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.

Primary outcomes:
measure: Muscle mass
timeFrame: 60 days after intervention
Secondary outcomes:
measure: BMI
timeFrame: 60 days after intervention
measure: Hand grips muscle strength
timeFrame: 60 days after intervention
measure: serum NF-kB level
timeFrame: 60 days after intervention
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Phramongkutklao Hospital
state: Bangkok
Study officials:
affiliation: Phramongkutklao College of Medicine and Hospital
name: Tawasapon Thambamroong, MD
role: PRINCIPAL_INVESTIGATOR
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