Clinical trial NCT06517199: Olanzapine for Cancer Related Anorexia-cachexia Syndrome
Official title: Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Anorexia
Cachexia
Keywords: cancer anorexia
olanzapine
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: no greater than 5% weight loss in olanzapine 2.5 mg versus placebo
timeFrame: 4 weeks
Secondary outcomes:
measure: no greater than 5% weight loss in olanzapine 5 mg versus placebo
timeFrame: 4 weeks
measure: numerical scale of anorexia
timeFrame: 4 weeks
measure: body weight
timeFrame: week 2 and 4
measure: adverse effects
timeFrame: week 1, 2, 3, 4
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
city: Bangkok
country: Thailand
facility: Division of medical oncology, department of medicine Siriraj Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.