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

March 8, 2024 updated by: Rajavithi Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: weight gain each group
weight gain after 12 Weeks
Other Names:
  • body weight
Experimental: Olanzapine
Olanzapine 5 mg oral OD
Other: weight gain each group
weight gain after 12 Weeks
Other Names:
  • body weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajavithi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 3, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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