About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Olanzapine 2.5 MG
Drugolanzapine 2.5 mg/day for 28 days
Olanzapine 5 MG
Drugolanzapine 5 mg/day for 28 days
Placebo
Drugplacebo 1 tab/day for 28 days
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
no greater than 5% weight loss in olanzapine 5 mg versus placebo
proportion of patients with olanzapine 5 mg without greater or equal to 5% weight loss compared to placebo
numerical scale of anorexia
proportion of patients with decreased numerical scale of anorexia
body weight
body weight change from baseline
adverse effects
adverse effects
Sponsors and contacts
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