Letrozole as a Prophylaxis From GTN for Complete Mole Patients

July 11, 2022 updated by: Mohamed Ali Alabiad, MD, Zagazig University

The Prophylactic Role of Aromatase Inhibitor Letrozole in Decreasing the Incidence of Gestational Trophoblastic Neoplasia in Patients With Complete Hydatidiform Mole

Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Management of hydatidiform mole is usually evacuation followed by β-hcg surveillance to early detect cases of GTN . The risk of developing GTN is reported to be 16% to 20% in women with CHM . GTN is a potentially life-threatening malignancy but has an excellent cure rate. Trials were conducted to assess the role of prophylactic chemotherapy to prevent the development of GTN. In addition to their side effects, a meta-analysis concluded that there is insufficient evidence to support the use of prophylactic chemotherapy in clinical practice. Third-generation aromatase inhibitors such as letrozole have been shown to successfully block estrogen production in women of reproductive age. Their safety, high tolerability, low cost, and associated minimal adverse effects have all been established over several decades of clinical use and recently used successfully alone in the medical treatment of ectopic pregnancy making marked degenerative effects on the placenta.

The study hypothesizes that by inhibiting the estrogen synthetase (the aromatase enzyme) progesterone would not exert its physiological role in maintaining early pregnancy including complete hydatidiform mole. Thus, using a prophylactic aromatase inhibitor after CHM may have a role in the prevention of GTN and more effective clearance of β-hcg.

Rational GTN is a potentially life-threatening malignancy. The risk of progression of CHM to GTN is 20%. Prophylactic use of aromatase inhibitor may decrease the incidence of GTN.

Research question:

Is prophylactic use of aromatase inhibitor effective in decreasing the incidence of GTN in patients with CHM

Hypothesis Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM

Aim of this work The study aims at figuring out whether prophylactic use of aromatase inhibitor is effective in decreasing the incidence of GTN in patients with CHM.

OBJECTIVES

  • To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
  • To assess the incidence of GTN after the evacuation of CHM without prophylactic use of aromatase inhibitor.
  • To assess the side effects of aromatase inhibitor when used as a prophylaxis against GTN development in CHM cases.

PATIENTS AND METHODS

Technical design:

  • Setting: Department of Obstetrics and Gynecology
  • Sample size: 200 patients diagnosed to have CHM by ultrasound and confirmed by histopathological examination.

Operational design:

  • Type of the study: a randomized controlled trial.
  • Steps of performance and techniques that will be used

women included in the study will be subjected to the following

Preoperative

  1. Complete history taking.
  2. General and abdominal examination.
  3. Routine preoperative laboratory investigations.
  4. Ultrasound to diagnose complete hydatidiform mole.

  5. Measurement of β-hcg level. Intraoperative

    • Evacuation of CHM using Suction curettage.
    • Tissues obtained during an evacuation will be sent for histological assessment. Post-operative
    • Women will be randomized classified into two groups
    • Control group I: Conservative follow up
    • Prophylactic letrozole group II 5-mg Letrozole will be administered as two 2.5-mg tablets every day for 10 days.
    • All Patients will receive instruction to return for β-hcg follow up which will be done weekly till complete resolution then monthly for 6 months.
    • Participants will be advised to receive contraception during the follow-up period.
    • The patients who will develop GTN in either group will be picked up and the incidence of GTN will be calculated in each group.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 14150
        • Mohamed ALI Alabiad

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women were diagnosed to have CHM by ultrasound and confirmed by histopathological examination

Exclusion Criteria:

  • Metastatic disease associated with HM at presentation, in which situation chemotherapy, rather than prophylactic treatment, as prescribed,
  • Late diagnosis of CHM made only by histological examination of curetted material
  • Uterine evacuation at another hospital and patient seen at the optimum patient care only for follow up

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
Active Comparator: Control group I
Patients with complete mole treated by evacuation of using suction curettage followed by conservative follow up
Procedure: Suction evacuation
both groups underwent complete mole evacuation using suction curettage.
Other Names:
  • Evacuation of CHM using Suction curettage
Experimental: Prophylactic letrozole group II
Patients with complete mole treated by evacuation of using suction curettage followed by 5mg daily letrozole for 10 days followed by conservative follow up
Procedure: Suction evacuation
both groups underwent complete mole evacuation using suction curettage.
Other Names:
  • Evacuation of CHM using Suction curettage
Drug: Letrozole tablets
Group II Patients received 5mg(2tablets 2.5gm) daily letrozole for 10 days after complete mole evacuation
Other Names:
  • 5mg daily (2 tablets 2.5 gm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(β-hCG) level
Time Frame: at the first day of evacuation
A quantitative human chorionic gonadotropin
at the first day of evacuation
(β-hCG) level
Time Frame: one month after evacuation
A quantitative human chorionic gonadotropin
one month after evacuation
(β-hCG) level
Time Frame: two months after evacuation
A quantitative human chorionic gonadotropin
two months after evacuation
(β-hCG) level
Time Frame: three months after evacuation
A quantitative human chorionic gonadotropin
three months after evacuation
(β-hCG) level
Time Frame: four months after evacuation
A quantitative human chorionic gonadotropin
four months after evacuation
(β-hCG) level
Time Frame: Five months after evacuation
A quantitative human chorionic gonadotropin
Five months after evacuation
(β-hCG) level
Time Frame: Six months after evacuation
A quantitative human chorionic gonadotropin
Six months after evacuation

Collaborators and Investigators

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

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Mohamed A Alabiad, MD, Zagazig University

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 (Actual)

June 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LETROZOLE IN CHM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

3 months after final complete

IPD Sharing Time Frame

3 months after final complete

IPD Sharing Access Criteria

Contac dr Mohamed at drno99@yahoo.com

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (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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