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

NCT06288854 | Recruiting

• 1 other identifier: 66222
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Weight Gain

Outcome Measures

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

  12 weeks after intervention

Study Arms (2)

Olanzapine

EXPERIMENTAL

Olanzapine 5 mg oral OD

Other: weight gain each group

Placebo

PLACEBO COMPARATOR

Placebo

Other: weight gain each group

Interventions

weight gain each group OTHER

weight gain after 12 Weeks

Also known as: body weight

Olanzapine; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Weight Gain

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: olanzapine vs placebo

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: April 3, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TH (1)