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RecruitingNCT06288854Updated Nov 21, 2024

Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer with Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial

An interventional study of weight gain each group in Weight Gain, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Recruiting at 1 site in Thailand. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.

Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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 the detailed description

-Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo

02

Conditions studied

  • Weight Gain

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03

In context

Weight Gain

317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.

This study's planned enrollment of 48 is below the median of 83 across 251 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 39 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Advanced stage gynecologic cancer receiving Paclitaxel and carboplatin chemotherapy
  • 0-1
  • Normal CBC,Liver, renal function
  • Communication in Thai language or Thai caregiver
  • Inform consent

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

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.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Olanzapine

    Olanzapine 5 mg oral OD

    Other: weight gain each group

  • Placebo comparator
    Placebo

    Placebo

    Other: weight gain each group

Interventions

  • Otherweight gain each group

    weight gain after 12 Weeks

    Also known as: body weight

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 weeks after intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06288854
Lead sponsor
Department of Medical Services Ministry of Public Health of Thailand
Responsible party
Sponsor
First posted
Mar 1, 2024
Start date
Apr 3, 2024
Primary completion
Mar 31, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Nov 21, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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