Anorexia, Cachexia
Conditions
Keywords
cancer anorexia, olanzapine
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.
Interventions
olanzapine 2.5 mg/day for 28 days
DRUGOlanzapine 5 MG
olanzapine 5 mg/day for 28 days
DRUGPlacebo
placebo 1 tab/day for 28 days
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| no greater than 5% weight loss in olanzapine 2.5 mg versus placebo | 4 weeks | proportion of patients with olanzapine 2.5 mg without greater or equal to 5% weight loss compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| no greater than 5% weight loss in olanzapine 5 mg versus placebo | 4 weeks | proportion of patients with olanzapine 5 mg without greater or equal to 5% weight loss compared to placebo |
| numerical scale of anorexia | 4 weeks | proportion of patients with decreased numerical scale of anorexia |
| body weight | week 2 and 4 | body weight change from baseline |
| adverse effects | week 1, 2, 3, 4 | adverse effects |
Countries
Thailand
Contacts
Primary ContactSuthinee Ithimakin, MD
Outcome results
None listed