Olanzapine for Cancer Related Anorexia-cachexia Syndrome

July 18, 2024 updated by: Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Division of medical oncology, department of medicine Siriraj Hospital
        • Contact:
        • Principal Investigator:
          • Suthinee Ithimakin, MD
        • Sub-Investigator:
          • Akarin Nimmannit, MD
        • Sub-Investigator:
          • Apirom Laocharoenkeat, MS
        • Sub-Investigator:
          • Ruamporn Kaewvichit, MD
        • Sub-Investigator:
          • Pinyo Sriveerachai, MD
        • Sub-Investigator:
          • Pornpoj Pramyothin, MD
      • Bangkok, Thailand, 10260
        • Recruiting
        • Faculty of Medicine Siriraj Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo 1 tablet/day for 28 days
Drug: Placebo
placebo 1 tab/day for 28 days
Other Names:
  • PLC
Active Comparator: olanzapine 2.5
olanzapine 2.5 mg/day for 28 days
Drug: Olanzapine 2.5 MG
olanzapine 2.5 mg/day for 28 days
Other Names:
  • OLN2.5
Active Comparator: olanzapine 5
olanzapine 5 mg/day for 28 days
Drug: Olanzapine 5 MG
olanzapine 5 mg/day for 28 days
Other Names:
  • OLN5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
no greater than 5% weight loss in olanzapine 2.5 mg versus placebo
Time Frame: 4 weeks
proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

January 21, 2026

Study Completion (Estimated)

January 21, 2026

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980/2566(IRB1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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