The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer
NCT ID: NCT04208334
Last Updated: 2023-03-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-02-13
Study Completion Date
2021-03-31
Brief Summary
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A study of Curcumin to prevent cancer anorexia and cachexia Syndrom in locally advance and advance stage head and neck cancer (stage III, IV)
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Detailed Description
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Conditions
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Cancer Cachexia
Head and Neck Cancer
Head and Neck Neoplasms
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Curcumin
Curcumin 4000mg/day x 60 days
Group Type
EXPERIMENTAL
Curcumin
Intervention Type
DIETARY_SUPPLEMENT
We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.
Placebo
Placebo x 60 days
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
We give a control arm to consume placebo for 60 consecutive days.
Interventions
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Curcumin
We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.
Intervention Type
DIETARY_SUPPLEMENT
Placebo
We give a control arm to consume placebo for 60 consecutive days.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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.
* History of allergy to Curcumin or herbal medicine
* History of Herbal medicine used
* History of Billiary of obstruction
* History of Antiplatelete or anticoagulant.
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Phramongkutklao College of Medicine and Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Tawasapon Thambamroong, MD
Role: PRINCIPAL_INVESTIGATOR
Phramongkutklao College of Medicine and Hospital
Locations
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Phramongkutklao Hospital
Ratchathewi, Bangkok, Thailand
Site Status
Countries
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Thailand
References
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Argiles JM, Busquets S, Stemmler B, Lopez-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014 Nov;14(11):754-62. doi: 10.1038/nrc3829. Epub 2014 Oct 9.
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BACKGROUND
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Meriggi F. Cancer Cachexia: One Step Ahead. Rev Recent Clin Trials. 2015;10(3):246-50. doi: 10.2174/1574887110666150916141351.
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Argiles JM, Lopez-Soriano FJ. The ubiquitin-dependent proteolytic pathway in skeletal muscle: its role in pathological states. Trends Pharmacol Sci. 1996 Jun;17(6):223-6. doi: 10.1016/0165-6147(96)10021-3.
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RESULT
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RESULT
Martin L, Birdsell L, Macdonald N, Reiman T, Clandinin MT, McCargar LJ, Murphy R, Ghosh S, Sawyer MB, Baracos VE. Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol. 2013 Apr 20;31(12):1539-47. doi: 10.1200/JCO.2012.45.2722. Epub 2013 Mar 25.
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RESULT
Cheng AL, Hsu CH, Lin JK, Hsu MM, Ho YF, Shen TS, Ko JY, Lin JT, Lin BR, Ming-Shiang W, Yu HS, Jee SH, Chen GS, Chen TM, Chen CA, Lai MK, Pu YS, Pan MH, Wang YJ, Tsai CC, Hsieh CY. Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. Anticancer Res. 2001 Jul-Aug;21(4B):2895-900.
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RESULT
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RESULT
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RESULT
Siddiqui RA, Hassan S, Harvey KA, Rasool T, Das T, Mukerji P, DeMichele S. Attenuation of proteolysis and muscle wasting by curcumin c3 complex in MAC16 colon tumour-bearing mice. Br J Nutr. 2009 Oct;102(7):967-75. doi: 10.1017/S0007114509345250. Epub 2009 Apr 27.
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RESULT
Gil da Costa RM, Aragao S, Moutinho M, Alvarado A, Carmo D, Casaca F, Silva S, Ribeiro J, Sousa H, Ferreira R, Nogueira-Ferreira R, Pires MJ, Colaco B, Medeiros R, Venancio C, Oliveira MM, Bastos MM, Lopes C, Oliveira PA. HPV16 induces a wasting syndrome in transgenic mice: Amelioration by dietary polyphenols via NF-kappaB inhibition. Life Sci. 2017 Jan 15;169:11-19. doi: 10.1016/j.lfs.2016.10.031. Epub 2016 Nov 22.
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RESULT
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RESULT
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Reference Type
RESULT
Thambamroong T, Seetalarom K, Saichaemchan S, Pumsutas Y, Prasongsook N. Efficacy of Curcumin on Treating Cancer Anorexia-Cachexia Syndrome in Locally or Advanced Head and Neck Cancer: A Double-Blind, Placebo-Controlled Randomised Phase IIa Trial (CurChexia). J Nutr Metab. 2022 Jun 2;2022:5425619. doi: 10.1155/2022/5425619. eCollection 2022.
Reference Type
DERIVED
Other Identifiers
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R119h/61
Identifier Type: -
Identifier Source: org_study_id
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