AnorexiaPhase 3NCT06517199
Olanzapine for Cancer Related Anorexia-cachexia Syndrome
A Phase 3 study testing Olanzapine 2.5 MG and Olanzapine 5 MG in people with Anorexia and Cachexia, run by Mahidol University at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Olanzapine 2.5 MG and Olanzapine 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 2 sitesThailand
- Study dates
- 22 Jan 2024to 21 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital
Bangkok, 10260
Suthinee Ithimakin, 0898127440, aesi105@yahoo.co.th
- Recruiting
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, 10700
Suthinee Ithimakin, MD, 662-419-4489, aesi105@yahoo.co.th
Suthinee Ithimakin, MD
About this study
Official title: Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome
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.
- Being tested
- Olanzapine 2.5 MG, Olanzapine 5 MG, Placebo
- Keywords
- cancer anorexia, olanzapine
- Medical subject headings
- Anorexia, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine 2.5 MGDrug
Also called OLN2.5
olanzapine 2.5 mg/day for 28 days
Olanzapine 5 MGDrug
Also called OLN5
olanzapine 5 mg/day for 28 days
PlaceboDrug
Also called PLC
placebo 1 tab/day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo 1 tablet/day for 28 days Receives: Drug: Placebo |
| olanzapine 2.5 | Active comparator | olanzapine 2.5 mg/day for 28 days Receives: Drug: Olanzapine 2.5 MG |
| olanzapine 5 | Active comparator | olanzapine 5 mg/day for 28 days Receives: Drug: Olanzapine 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (4)
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
Measured: 4 weeks
numerical scale of anorexia
proportion of patients with decreased numerical scale of anorexia
Measured: 4 weeks
body weight
body weight change from baseline
Measured: week 2 and 4
adverse effects
adverse effects
Measured: week 1, 2, 3, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start22 Jan 2024
- Primary completion21 Jan 2026 (estimated)
- Study completion21 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnorexiaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517199
- Sponsor's protocol ID
- 980/2566(IRB1)
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not yet decided
Publications
Navari RM, Brenner MC. Treatment of cancer-related anorexia with olanzapine and megestrol acetate: a randomized trial. Support Care Cancer. 2010 Aug;18(8):951-6. doi: 10.1007/s00520-009-0739-7. Epub 2009 Sep 11.
PubMed 19756773Sandhya L, Devi Sreenivasan N, Goenka L, Dubashi B, Kayal S, Solaiappan M, Govindarajalou R, Kt H, Ganesan P. Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer. J Clin Oncol. 2023 May 10;41(14):2617-2627. doi: 10.1200/JCO.22.01997. Epub 2023 Mar 28.
PubMed 36977285Arends J, Strasser F, Gonella S, Solheim TS, Madeddu C, Ravasco P, Buonaccorso L, de van der Schueren MAE, Baldwin C, Chasen M, Ripamonti CI; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Cancer cachexia in adult patients: ESMO Clinical Practice Guidelines☆. ESMO Open. 2021 Jun;6(3):100092. doi: 10.1016/j.esmoop.2021.100092.
PubMed 34144781Roeland EJ, Bohlke K, Baracos VE, Bruera E, Del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020 Jul 20;38(21):2438-2453. doi: 10.1200/JCO.20.00611. Epub 2020 May 20.
PubMed 32432946
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Study of Olanzapine for Cancer Related Anorexia-cachexia Syndrome
- ClinicalTrials.gov ID
- NCT06517199
- Acronym / sponsor ID
- 980/2566(IRB1)
- Keywords
- cancer anorexia, olanzapine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 21 Jan 2026 (estimated)
- Study completion
- 21 Jan 2026 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placeboplacebo 1 tablet/day for 28 days |
| olanzapine 2.5 | Active comparator | Drug: Olanzapine 2.5 MGolanzapine 2.5 mg/day for 28 days |
| olanzapine 5 | Active comparator | Drug: Olanzapine 5 MGolanzapine 5 mg/day for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine 2.5 MGAlso: OLN2.5olanzapine 2.5 mg/day for 28 days | Drug | olanzapine 2.5 |
| Olanzapine 5 MGAlso: OLN5olanzapine 5 mg/day for 28 days | Drug | olanzapine 5 |
| PlaceboAlso: PLCplacebo 1 tab/day for 28 days | Drug | placebo |
Primary outcome
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
4 secondary outcomes
no greater than 5% weight loss in olanzapine 5 mg versus placebo
Time frame: 4 weeks
numerical scale of anorexia
Time frame: 4 weeks
body weight
Time frame: week 2 and 4
adverse effects
Time frame: week 1, 2, 3, 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 19756773Navari RM, Brenner MC. Treatment of cancer-related anorexia with olanzapine and megestrol acetate: a randomized trial. Support Care Cancer. 2010 Aug;18(8):951-6. doi: 10.1007/s00520-009-0739-7. Epub 2009 Sep 11.
- Background: PubMed 36977285Sandhya L, Devi Sreenivasan N, Goenka L, Dubashi B, Kayal S, Solaiappan M, Govindarajalou R, Kt H, Ganesan P. Randomized Double-Blind Placebo-Controlled Study of Olanzapine for Chemotherapy-Related Anorexia in Patients With Locally Advanced or Metastatic Gastric, Hepatopancreaticobiliary, and Lung Cancer. J Clin Oncol. 2023 May 10;41(14):2617-2627. doi: 10.1200/JCO.22.01997. Epub 2023 Mar 28.
- Background: PubMed 34144781Arends J, Strasser F, Gonella S, Solheim TS, Madeddu C, Ravasco P, Buonaccorso L, de van der Schueren MAE, Baldwin C, Chasen M, Ripamonti CI; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Cancer cachexia in adult patients: ESMO Clinical Practice Guidelines☆. ESMO Open. 2021 Jun;6(3):100092. doi: 10.1016/j.esmoop.2021.100092.
- Background: PubMed 32432946Roeland EJ, Bohlke K, Baracos VE, Bruera E, Del Fabbro E, Dixon S, Fallon M, Herrstedt J, Lau H, Platek M, Rugo HS, Schnipper HH, Smith TJ, Tan W, Loprinzi CL. Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020 Jul 20;38(21):2438-2453. doi: 10.1200/JCO.20.00611. Epub 2020 May 20.
- Individual participant dataSharing planned: No. not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine 2.5 MG and Olanzapine 5 MG in people with Anorexia and Cachexia, run by Mahidol University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suthinee Ithimakin, MD (+66824194489, aesi105@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no greater than 5% weight loss in olanzapine 2.5 mg versus placebo (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06517199, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.