Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Mahidol University
- Enrollment
- 138
- Locations
- 2
- Primary Endpoint
- no greater than 5% weight loss in olanzapine 2.5 mg versus placebo
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
placebo
placebo 1 tablet/day for 28 days
Intervention: Placebo (Drug)
olanzapine 2.5
olanzapine 2.5 mg/day for 28 days
Intervention: Olanzapine 2.5 MG (Drug)
olanzapine 5
olanzapine 5 mg/day for 28 days
Intervention: Olanzapine 5 MG (Drug)
Outcomes
Primary Outcomes
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
- numerical scale of anorexia(4 weeks)
- adverse effects(week 1, 2, 3, 4)
- no greater than 5% weight loss in olanzapine 5 mg versus placebo(4 weeks)
- body weight(week 2 and 4)