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

Phase 2

Completed

• Conditions: Head and Neck Neoplasms; Cancer Cachexia; Head and Neck Cancer
• Interventions: Dietary Supplement: Curcumin; Other: Placebo

• Registration Number: NCT04208334
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Study Start: 2020-02-13
• Primary Completion: 2021-02-24
• Study Completion: 2021-03-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin	Curcumin	Curcumin 4000mg/day x 60 days
Placebo	Placebo	Placebo x 60 days

Primary Outcome Measures

Name	Time	Method
Muscle mass	60 days after intervention	We measure muscle mass by Bioelectrical Impedance Analysis (BIA)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Phramongkutklao Hospital; 🇹🇭 Ratchathewi, Bangkok, Thailand