Olanzapine for Cancer Related Anorexia-cachexia Syndrome

NCT06517199 | Recruiting Phase 3

• 1 other identifier: 980/2566(IRB1)
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

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.

Conditions

Anorexia; Cachexia

Keywords

cancer anorexia; olanzapine

Outcome Measures

Primary Outcomes (1)

• no greater than 5% weight loss in olanzapine 2.5 mg versus placebo

  proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo

  4 weeks

Secondary Outcomes (4)

• no greater than 5% weight loss in olanzapine 5 mg versus placebo

  4 weeks

• numerical scale of anorexia

  4 weeks

• body weight

  week 2 and 4

• adverse effects

  week 1, 2, 3, 4

Study Arms (3)

placebo

PLACEBO COMPARATOR

placebo 1 tablet/day for 28 days

Drug: Placebo

olanzapine 2.5

ACTIVE COMPARATOR

olanzapine 2.5 mg/day for 28 days

Drug: Olanzapine 2.5 MG

olanzapine 5

ACTIVE COMPARATOR

olanzapine 5 mg/day for 28 days

Drug: Olanzapine 5 MG

Interventions

Olanzapine 2.5 MG DRUG

olanzapine 2.5 mg/day for 28 days

Also known as: OLN2.5

olanzapine 2.5

Olanzapine 5 MG DRUG

olanzapine 5 mg/day for 28 days

Also known as: OLN5

olanzapine 5

Placebo DRUG

placebo 1 tab/day for 28 days

Also known as: PLC

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (2)

Faculty of Medicine Siriraj Hospital

Bangkok, 10260, Thailand

RECRUITING

Division of medical oncology, department of medicine Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Anorexia; Cachexia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Suthinee Ithimakin, MD

CONTACT

+66824194489; aesi105@yahoo.co.th

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: January 22, 2024
• Primary Completion: January 21, 2026
• Study Completion: January 21, 2026
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)