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Cancer CachexiaPhase 2CurChexiaNCT04208334

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

A Phase 2 study testing Curcumin in people with Cancer Cachexia and Head and Neck Cancer, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Curcumin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteThailand
Study dates
13 Feb 2020to 31 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Pregnancy
  • History of allergy to Curcumin or herbal medicine
  • History of Herbal medicine used
  • History of Billiary of obstruction
  • History of Antiplatelete or anticoagulant.

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Phramongkutklao Hospital

    Ratchathewi, Bangkok, 10400'

Other trials in Thailand

About this study

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

A study of Curcumin to prevent cancer anorexia and cachexia Syndrom in locally advance and advance stage head and neck cancer (stage III, IV)

Being tested
Curcumin, Placebo
Keywords
Cancer cachexia, Head and neck cancer, Curcumin, Tumuric, Cancer anorexia cachexia
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurcuminDietary supplement

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

  • PlaceboOther

    We give a control arm to consume placebo for 60 consecutive days.

Study groups in NCT04208334
Study groupRoleWhat they receive
CurcuminExperimentalCurcumin 4000mg/day x 60 days
Receives: Dietary Supplement: Curcumin
PlaceboPlacebo comparatorPlacebo x 60 days
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle mass

    We measure muscle mass by Bioelectrical Impedance Analysis (BIA)

    Measured: 60 days after intervention

Secondary outcomes (3)

  1. BMI

    We measure BMI by Bioelectrical Impedance Analysis (BIA)

    Measured: 60 days after intervention

  2. Hand grips muscle strength

    We measure hand grips power by Hand grip test

    Measured: 60 days after intervention

  3. serum NF-kB level

    We measure serum NF-kB by ELISA

    Measured: 60 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2019
  2. Study start13 Feb 2020
  3. Primary completion24 Feb 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04208334
Sponsor's protocol ID
R119h/61
Acronym
CurChexia
Status last verified
Mar 2023
First submitted
19 Dec 2019
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25291291

  • Puigserver P, Rhee J, Lin J, Wu Z, Yoon JC, Zhang CY, Krauss S, Mootha VK, Lowell BB, Spiegelman BM. Cytokine stimulation of energy expenditure through p38 MAP kinase activation of PPARgamma coactivator-1. Mol Cell. 2001 Nov;8(5):971-82. doi: 10.1016/s1097-2765(01)00390-2.

    PubMed 11741533

  • Meriggi F. Cancer Cachexia: One Step Ahead. Rev Recent Clin Trials. 2015;10(3):246-50. doi: 10.2174/1574887110666150916141351.

    PubMed 26435290

  • 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.

    PubMed 8763200

  • Glass DJ. Signaling pathways perturbing muscle mass. Curr Opin Clin Nutr Metab Care. 2010 May;13(3):225-9. doi: 10.1097/mco.0b013e32833862df.

    PubMed 20397318

  • Constantinou C, Fontes de Oliveira CC, Mintzopoulos D, Busquets S, He J, Kesarwani M, Mindrinos M, Rahme LG, Argiles JM, Tzika AA. Nuclear magnetic resonance in conjunction with functional genomics suggests mitochondrial dysfunction in a murine model of cancer cachexia. Int J Mol Med. 2011 Jan;27(1):15-24. doi: 10.3892/ijmm.2010.557. Epub 2010 Nov 10.

    PubMed 21069263

  • Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.

    PubMed 27637832

  • Laviano A, Seelaender M, Sanchez-Lara K, Gioulbasanis I, Molfino A, Rossi Fanelli F. Beyond anorexia -cachexia. Nutrition and modulation of cancer patients' metabolism: supplementary, complementary or alternative anti-neoplastic therapy? Eur J Pharmacol. 2011 Sep;668 Suppl 1:S87-90. doi: 10.1016/j.ejphar.2011.06.060. Epub 2011 Jul 27.

    PubMed 21810420

  • Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.

    PubMed 7424938

  • Teunissen SC, Wesker W, Kruitwagen C, de Haes HC, Voest EE, de Graeff A. Symptom prevalence in patients with incurable cancer: a systematic review. J Pain Symptom Manage. 2007 Jul;34(1):94-104. doi: 10.1016/j.jpainsymman.2006.10.015. Epub 2007 May 23.

    PubMed 17509812

  • Evans WK, Makuch R, Clamon GH, Feld R, Weiner RS, Moran E, Blum R, Shepherd FA, Jeejeebhoy KN, DeWys WD. Limited impact of total parenteral nutrition on nutritional status during treatment for small cell lung cancer. Cancer Res. 1985 Jul;45(7):3347-53.

    PubMed 2988769

  • 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.

    PubMed 23530101

  • 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.

    PubMed 11712783

  • Dhillon N, Aggarwal BB, Newman RA, Wolff RA, Kunnumakkara AB, Abbruzzese JL, Ng CS, Badmaev V, Kurzrock R. Phase II trial of curcumin in patients with advanced pancreatic cancer. Clin Cancer Res. 2008 Jul 15;14(14):4491-9. doi: 10.1158/1078-0432.CCR-08-0024.

    PubMed 18628464

  • Thomas R, Williams M, Sharma H, Chaudry A, Bellamy P. A double-blind, placebo-controlled randomised trial evaluating the effect of a polyphenol-rich whole food supplement on PSA progression in men with prostate cancer--the U.K. NCRN Pomi-T study. Prostate Cancer Prostatic Dis. 2014 Jun;17(2):180-6. doi: 10.1038/pcan.2014.6. Epub 2014 Mar 11.

    PubMed 24614693

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Curcumin in people with Cancer Cachexia and Head and Neck Cancer, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle mass (time frame: 60 days after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04208334, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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