Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05203562 |
| Other study ID # |
LETROZOLE IN CHM |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
July 2022 |
| Source |
Zagazig University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Prophylactic use of aromatase inhibitor is effective in decreasing the incidence of
Gestational Trophoblastic Neoplasia (GTN) in patients with complete hydatidiform mole (CHM)
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.
