Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma

NCT ID: NCT01968317

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-10-31

Brief Summary

The purpose of this study is to see if megestrol acetate plus metformin will be more effective in returning the endometrial tissue to a normal state than megestrol acetate alone in patients with endometrial atypical hyperplasia or early stage endometrial adenocarcinoma.

Detailed Description

After diagnosed of endometrial atypical hyperplasia(EAH) or type I endometrial cancer(EC) by dilatation and curettage (D&C) or hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including triglycerides, high density lipoprotein-cholesterol, fasting blood glucose, liver and kidney function will be performed before treatment to evacuate their metabolic conditions.

Patients are randomized to 1 of 2 treatment groups. Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months on Arm I. Patients will receive megestrol acetate 160 mg PO daily for 3 months on Arm II. Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded. For patients with EAH, complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. EAH after treatment will be defined as PR in patients with EC. Continuous therapies will be needed in PR, NR or PD.

After completion of study treatment, 3 months of maintenance treatment will be recommended for patients with CR, and they will be followed up for 2 years.

In addition, we've already had a pilot study in 19 patients primarily diagnosed of endometrial atypical hyperplasia from August 2012 to April 2013. 10 patients were in Arm I and 9 patients were in Arm II. Metabolic syndrome were evaluated among all subjects. After treatment, megestrol acetate plus metformin worked better than megestrol acetate alone. But two arms showed no difference in NR patients, which may suggest metformin just worked as an antitumor drug more than an insulin sensitizer. More supportive researches are needed to verify it.

Conditions

Endometrial Atypical Hyperplasia; Endometrial Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Megestrol acetate and metformin

Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Group Type: EXPERIMENTAL

Megestrol acetate and metformin

Intervention Type: DRUG

Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.

Megestrol acetate

Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.Then an hysteroscope will be used to evaluate the endometrial condition, and the findings will be recorded.

Group Type: EXPERIMENTAL

Megestrol acetate

Intervention Type: DRUG

Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.

Interventions

Megestrol acetate and metformin

Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.

Intervention Type: DRUG

Megestrol acetate

Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.

Intervention Type: DRUG

Other Intervention Names

Megestrol acetate: Megace; Metformin: Fortamet, Glucophage; Megestrol acetate: Megace

Eligibility Criteria

Inclusion Criteria

• Be between the ages of 18-45 years old
• Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon D&C or hysteroscopy

• OR primarily have a confirmed diagnosis of endometrial adenocarcinoma(G1, low tumor grade), based upon D&C or hysteroscopy, and three MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
• Have a desire for remaining reproductive function or uterus
• Need to be able to undergo correlative treatment and follow-up

Exclusion Criteria

• Have a history of serious liver or renal dysfunction
• Have a confirmed diagnosis of malignant tumor in genital system
• Have taken oral contraceptive or other medicine for the treatment of endometrial hyperplasia in the past 6 months
• Ask for removal of the uterus or other conservative treatment
• serum CA-125 > 35 Um/L

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Shanghai Changning Maternity & Infant Health Hospital

OTHER

Sponsor Role: collaborator

Xiaojun Chen

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Chen

Deputy Secretary of the Party committee

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiaojun Chen, PhD

Role: STUDY_CHAIR

Obstetrics & Gynecology Hospital of Fudan University

Locations

Obstetrics and Gynecology Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Changning Maternity & Infant Health Hospital

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

134119a4500

Identifier Type: -

Identifier Source: org_study_id