Olanzapine for Cancer Related Anorexia-cachexia Syndrome
NCT ID: NCT06517199
Last Updated: 2024-07-24
Study Results
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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RECRUITING
PHASE3
138 participants
INTERVENTIONAL
2024-01-22
2026-01-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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placebo
placebo 1 tablet/day for 28 days
Placebo
placebo 1 tab/day for 28 days
olanzapine 2.5
olanzapine 2.5 mg/day for 28 days
Olanzapine 2.5 MG
olanzapine 2.5 mg/day for 28 days
olanzapine 5
olanzapine 5 mg/day for 28 days
Olanzapine 5 MG
olanzapine 5 mg/day for 28 days
Interventions
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Olanzapine 2.5 MG
olanzapine 2.5 mg/day for 28 days
Olanzapine 5 MG
olanzapine 5 mg/day for 28 days
Placebo
placebo 1 tab/day for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* anorexia and \>=5% weight loss during the past 6 months or anorexia with numerical scale of anorexia \>=5
* ECOG performance status 0-3
* able to complete questionaire and able to swallow pills
Exclusion Criteria
* life expectancy longer than 1 month
* received radiotherapy at head/neck or thoracic or upper abdomen in the past 2 weeks
* surgery within 4 weeks
* pregnancy
* serum bilirubin \> 2 mg/dl or serum Cr \> 2 mg/dl
* current use of olanzapine or other antipsychotic drug
* known cardiac arrhythmia, uncontrolled brain metastasis, history of seizure or acute coronary event in the past 6 months
18 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Locations
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Faculty of Medicine Siriraj Hospital
Bangkok, , Thailand
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Navari RM, Brenner MC. Treatment of cancer-related anorexia with olanzapine and megestrol acetate: a randomized trial. Support Care Cancer. 2010 Aug;18(8):951-6. doi: 10.1007/s00520-009-0739-7. Epub 2009 Sep 11.
Sandhya L, Devi Sreenivasan N, Goenka L, Dubashi B, Kayal S, Solaiappan M, Govindarajalou R, Kt H, Ganesan P. Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer. J Clin Oncol. 2023 May 10;41(14):2617-2627. doi: 10.1200/JCO.22.01997. Epub 2023 Mar 28.
Arends J, Strasser F, Gonella S, Solheim TS, Madeddu C, Ravasco P, Buonaccorso L, de van der Schueren MAE, Baldwin C, Chasen M, Ripamonti CI; ESMO Guidelines Committee. Electronic address: [email protected]. Cancer cachexia in adult patients: ESMO Clinical Practice Guidelines☆. ESMO Open. 2021 Jun;6(3):100092. doi: 10.1016/j.esmoop.2021.100092.
Roeland EJ, Bohlke K, Baracos VE, Bruera E, Del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020 Jul 20;38(21):2438-2453. doi: 10.1200/JCO.20.00611. Epub 2020 May 20.
Other Identifiers
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980/2566(IRB1)
Identifier Type: -
Identifier Source: org_study_id
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