Olanzapine for Cancer Related Anorexia-cachexia Syndrome

Mahidol University

Status and phase: Enrolling; Phase 3

Conditions: Anorexia; Cachexia

Treatments: Drug: Olanzapine 5 MG; Drug: Olanzapine 2.5 MG; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06517199

980/2566(IRB1)

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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138 participants in 3 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

placebo 1 tablet/day for 28 days

Treatment:

Drug: Placebo

olanzapine 2.5

Active Comparator group

Description:

olanzapine 2.5 mg/day for 28 days

Treatment:

Drug: Olanzapine 2.5 MG

olanzapine 5

Active Comparator group

Description:

olanzapine 5 mg/day for 28 days

Treatment:

Drug: Olanzapine 5 MG