Olanzapine for Cancer Related Anorexia-cachexia Syndrome

NCT06517199 — Phase 3, Unknown, 138 participants, Mahidol University

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Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Registry	NCT06517199
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	138 (Estimated)
Sponsor	Mahidol University (Other)
Conditions	Anorexia, Cachexia
Interventions	Olanzapine 2.5 MG, Olanzapine 5 MG, Placebo (Drug)
Dates	start 2024-01-22, primary completion 2026-01-21 (estimated), completion 2026-01-21 (estimated), first posted 2024-07-24, last updated 2024-07-24
Locations	2 sites in Thailand

-Summary

Cancer anorexia-cachexia syndrome is one of the common conditions in cancer patients. Olanzapine has been demonstrated to reduce chemotherapy-induced anorexia. However, there is scarce information regarding olanzapine as a treatment of cancer anorexia among patients who does not receive chemotherapy. Therefore, this randomized controlled trial aims to evaluate the efficacy of olanzapine to lessen cancer cachexia-anorexia syndrome.

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+Arms and interventions

Arm	Type	Interventions	Description
placebo	Placebo comparator	Drug: Placebo	placebo 1 tablet/day for 28 days
olanzapine 2.5	Active comparator	Drug: Olanzapine 2.5 MG	olanzapine 2.5 mg/day for 28 days
olanzapine 5	Active comparator	Drug: Olanzapine 5 MG	olanzapine 5 mg/day for 28 days

Olanzapine 2.5 MG (Drug), also known as OLN2.5: olanzapine 2.5 mg/day for 28 days
Olanzapine 5 MG (Drug), also known as OLN5: olanzapine 5 mg/day for 28 days
Placebo (Drug), also known as PLC: placebo 1 tab/day for 28 days

+Outcome measures

Primary outcomes

no greater than 5% weight loss in olanzapine 2.5 mg versus placebo [4 weeks]: proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo

Secondary outcomes

no greater than 5% weight loss in olanzapine 5 mg versus placebo [4 weeks]: proportion of patients with olanzapine 5 mg without greater or equal to 5% weight loss compared to placebo
numerical scale of anorexia [4 weeks]: proportion of patients with decreased numerical scale of anorexia
body weight [week 2 and 4]: body weight change from baseline
adverse effects [week 1, 2, 3, 4]: adverse effects

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* pathologically or cytologically metastatic or locally advanced cancer
* 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:

* receiving chemotherapy or anti-cancer systemic therapy
* 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

+Locations (2)

Facility	City	Country	Status
Faculty of Medicine Siriraj Hospital	Bangkok	Thailand	Recruiting
Division of medical oncology, department of medicine Siriraj Hospital	Bangkok	Thailand	Recruiting

+Publications

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. PMID 19756773
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. PMID 36977285
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: clinicalguidelines@esmo.org. Cancer cachexia in adult patients: ESMO Clinical Practice Guidelines☆. ESMO Open. 2021 Jun;6(3):100092. doi: 10.1016/j.esmoop.2021.100092. PMID 34144781
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. PMID 32432946