Back to resultsThe Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer (CurChexia)
Primary Purpose
Cancer Cachexia, Head and Neck Cancer, Head and Neck Neoplasms
Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Curcumin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cancer Cachexia focused on measuring Cancer cachexia, Head and neck cancer, Curcumin, Tumuric, Cancer anorexia cachexia
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.
Sites / Locations
- Phramongkutklao Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Curcumin
Placebo
Arm Description
Curcumin 4000mg/day x 60 days
Placebo x 60 days
Outcomes
Primary Outcome Measures
Muscle mass
We measure muscle mass by Bioelectrical Impedance Analysis (BIA)
Secondary Outcome Measures
BMI
We measure BMI by Bioelectrical Impedance Analysis (BIA)
Hand grips muscle strength
We measure hand grips power by Hand grip test
serum NF-kB level
We measure serum NF-kB by ELISA
Full Information
NCT ID
NCT04208334
First Posted
December 19, 2019
Last Updated
March 27, 2023
Sponsor
Phramongkutklao College of Medicine and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04208334
Brief Title
The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Cachexia, Head and Neck Cancer, Head and Neck Neoplasms
Keywords
Cancer cachexia, Head and neck cancer, Curcumin, Tumuric, Cancer anorexia cachexia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curcumin
Arm Type
Experimental
Arm Description
Curcumin 4000mg/day x 60 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo x 60 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Description
We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
We give a control arm to consume placebo for 60 consecutive days.
Primary Outcome Measure Information:
Title
Muscle mass
Description
We measure muscle mass by Bioelectrical Impedance Analysis (BIA)
Time Frame
60 days after intervention
Secondary Outcome Measure Information:
Title
BMI
Description
We measure BMI by Bioelectrical Impedance Analysis (BIA)
Time Frame
60 days after intervention
Title
Hand grips muscle strength
Description
We measure hand grips power by Hand grip test
Time Frame
60 days after intervention
Title
serum NF-kB level
Description
We measure serum NF-kB by ELISA
Time Frame
60 days after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tawasapon Thambamroong, MD
Organizational Affiliation
Phramongkutklao College of Medicine and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phramongkutklao Hospital
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400'
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Learn more about this trial
The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer
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