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

Head and Neck Cancer Clinical Trial

— CurChexia  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208334
• Other study ID #: R119h/61
• Status: Completed
• Phase: Phase 2
• Start date: February 13, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: March 2023
• Source: Phramongkutklao College of Medicine and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 31, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anorexia
• Cachexia
• Cancer Cachexia
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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

Other:
• Placebo
We give a control arm to consume placebo for 60 consecutive days.

Locations

Country	Name	City	State
Thailand	Phramongkutklao Hospital	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Phramongkutklao College of Medicine and Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	We measure muscle mass by Bioelectrical Impedance Analysis (BIA)	60 days after intervention
Secondary	BMI	We measure BMI by Bioelectrical Impedance Analysis (BIA)	60 days after intervention
Secondary	Hand grips muscle strength	We measure hand grips power by Hand grip test	60 days after intervention
Secondary	serum NF-kB level	We measure serum NF-kB by ELISA	60 days after intervention