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Trial Title:
Olanzapine for Cancer Related Anorexia-cachexia Syndrome
NCT ID:
NCT06517199
Condition:
Anorexia
Cachexia
Conditions: Official terms:
Wasting Syndrome
Anorexia
Cachexia
Olanzapine
Conditions: Keywords:
cancer anorexia
olanzapine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Olanzapine 2.5 MG
Description:
olanzapine 2.5 mg/day for 28 days
Arm group label:
olanzapine 2.5
Other name:
OLN2.5
Intervention type:
Drug
Intervention name:
Olanzapine 5 MG
Description:
olanzapine 5 mg/day for 28 days
Arm group label:
olanzapine 5
Other name:
OLN5
Intervention type:
Drug
Intervention name:
Placebo
Description:
placebo 1 tab/day for 28 days
Arm group label:
placebo
Other name:
PLC
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Faculty of Medicine Siriraj Hospital
Address:
City:
Bangkok
Zip:
10260
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Suthinee Ithimakin
Phone:
0898127440
Email:
aesi105@yahoo.co.th
Facility:
Name:
Division of medical oncology, department of medicine Siriraj Hospital
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Recruiting
Contact:
Last name:
Suthinee Ithimakin, MD
Phone:
662-419-4489
Email:
aesi105@yahoo.co.th
Investigator:
Last name:
Suthinee Ithimakin, MD
Email:
Principal Investigator
Investigator:
Last name:
Apirom Laocharoenkeat, MS
Email:
Sub-Investigator
Investigator:
Last name:
Akarin Nimmannit, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ruamporn Kaewvichit, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pinyo Sriveerachai, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pornpoj Pramyothin, MD
Email:
Sub-Investigator
Start date:
January 22, 2024
Completion date:
January 21, 2026
Lead sponsor:
Agency:
Mahidol University
Agency class:
Other
Source:
Mahidol University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06517199
