NCT04208334CompletedPhase 2
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
Phramongkutklao College of Medicine and Hospital1 site in 1 country20 target enrollmentStarted: February 13, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Muscle mass
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Placebo
Placebo Comparator
Placebo x 60 days
Intervention: Placebo (Other)
Curcumin
Experimental
Curcumin 4000mg/day x 60 days
Intervention: Curcumin (Dietary Supplement)
Outcomes
Primary Outcomes
Muscle mass
Time Frame: 60 days after intervention
We measure muscle mass by Bioelectrical Impedance Analysis (BIA)
Secondary Outcomes
- BMI(60 days after intervention)
- Hand grips muscle strength(60 days after intervention)
- serum NF-kB level(60 days after intervention)
Investigators
Study Sites (1)
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