A Phase 3 interventional study of Olanzapine 2.5 MG and Olanzapine 5 MG in Anorexia and Cachexia, sponsored by Mahidol University. Recruiting at 2 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by Mahidol University · Phase 3, Interventional, and Treatment
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.
163 studies on the registry are indexed under Anorexia; 25 are open to participants now.
This study's planned enrollment of 138 is above the median of 48 across 125 interventional studies indexed under Anorexia.
Browse Anorexia studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
placebo 1 tablet/day for 28 days
Drug: Placebo
olanzapine 2.5 mg/day for 28 days
Drug: Olanzapine 2.5 MG
olanzapine 5 mg/day for 28 days
Drug: Olanzapine 5 MG
olanzapine 2.5 mg/day for 28 days
Also known as: OLN2.5
olanzapine 5 mg/day for 28 days
Also known as: OLN5
placebo 1 tab/day for 28 days
Also known as: PLC
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
Time frame: 4 weeks
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
Time frame: 4 weeks
numerical scale of anorexia
proportion of patients with decreased numerical scale of anorexia
Time frame: 4 weeks
body weight
body weight change from baseline
Time frame: week 2 and 4
adverse effects
adverse effects
Time frame: week 1, 2, 3, 4
Plan to share: No — not yet decided
Started Jan 2024 (actual). Primary completion is estimated for Jan 2026, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Olanzapine