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NCT Number: NCT06517199

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Division of medical oncology, department of medicine Siriraj Hospital, Bangkok, Thailand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OLANZapine 2.5 MG

Drug

olanzapine 2.5 mg/day for 28 days

Other names: OLN2.5

Olanzapine 5 MG

Drug

olanzapine 5 mg/day for 28 days

Other names: OLN5

Placebo

Drug

placebo 1 tab/day for 28 days

Other names: PLC

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. numerical scale of anorexia

    Time frame: 4 weeks

    proportion of patients with decreased numerical scale of anorexia

  3. body weight

    Time frame: week 2 and 4

    body weight change from baseline

  4. adverse effects

    Time frame: week 1, 2, 3, 4

    adverse effects

Study contacts

Contact information is provided by the study sponsor or research team.

Suthinee Ithimakin, MD

CONTACT

[email protected]

+66824194489

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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