Weight GainNCT06288854
Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer with Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial
A study testing weight gain each group in people with Weight Gain, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- weight gain each group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 3 Apr 2024to 30 Jun 2025
- Phase
- Interventional
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Advanced stage gynecologic cancer receiving Paclitaxel and carboplatin chemotherapy
- ECOG 0-1
- Normal CBC,Liver, renal function
- Communication in Thai language or Thai caregiver
- Inform consent
Who cannot join
- Pregnancy
- Active infection
- Bowel obstruction or history of bowel surgery
- On dopamine receptor antagonists or psychiatric or anticonvulsant medication
- Olanzapine allery
- Abnormal function of liver and renal
- Diabetic melitus or morbid obesity
- patient can't selfcare
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Rajavithi Hospital
Bangkok
Putsarat Insin, 022062900, ec.rajavithihospital@gmail.com
About this study
Official title: Efficacy of Olanzapine on Weight Gain in Women with Advanced Stage Gynecologic Cancer Receiving Paclitaxel and Carboplatin Combination Chemotherapy : a Double Blind, Placebo-controlled Randomized Trial
- Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer
- Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo
Read the detailed description
-Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo
- Conditions
- Weight Gain
- Being tested
- weight gain each group
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight gain each groupOther
Also called body weight
weight gain after 12 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Olanzapine 5 mg oral OD Receives: Other: weight gain each group |
| Placebo | Placebo comparator | Placebo Receives: Other: weight gain each group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy
proprotion of pateints gain weight after intervention (olanzapine or placebo) by monitor weight before and after get intervention
Measured: 12 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start3 Apr 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- olanzapine vs placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288854
- Sponsor's protocol ID
- 66222
- Status last verified
- Mar 2024
- First submitted
- 23 Feb 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Olanzapine on Weight Gain in Women with Advanced Stage Gynecologic Cancer Receiving Paclitaxel and Carboplatin Combination Chemotherapy : a Double Blind, Placebo-controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT06288854
- Acronym / sponsor ID
- 66222
- Conditions
- Weight Gain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Mar 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.
- Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer
- Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo
Detailed description
-Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- olanzapine vs placebo
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Other: weight gain each groupOlanzapine 5 mg oral OD |
| Placebo | Placebo comparator | Other: weight gain each groupPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced stage gynecologic cancer receiving Paclitaxel and carboplatin chemotherapy
- ECOG 0-1
- Normal CBC,Liver, renal function
- Communication in Thai language or Thai caregiver
- Inform consent
Key exclusion criteria (8 listed)
- Pregnancy
- Active infection
- Bowel obstruction or history of bowel surgery
- On dopamine receptor antagonists or psychiatric or anticonvulsant medication
- Olanzapine allery
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 |
|---|---|---|
| weight gain each groupAlso: body weightweight gain after 12 Weeks | Other | Olanzapine, Placebo |
Primary outcome
Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy
Time frame: 12 weeks after intervention
proprotion of pateints gain weight after intervention (olanzapine or placebo) by monitor weight before and after get intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weight gain each group in people with Weight Gain, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site 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 5 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy (time frame: 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2024.