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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968317
Recruitment Status : Completed
First Posted : October 24, 2013
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Fudan University
Shanghai 6th People's Hospital
Zhejiang Cancer Hospital
Shanghai Changning Maternity & Infant Health Hospital
Information provided by (Responsible Party):
Xiaojun Chen, Fudan University

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.

Condition or disease Intervention/treatment Phase
Endometrial Atypical Hyperplasia Endometrial Adenocarcinoma Drug: Megestrol acetate and metformin Drug: Megestrol acetate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
Study Start Date : October 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Megestrol acetate: Megace
  • Metformin: Fortamet, Glucophage

Experimental: 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.
Drug: Megestrol acetate
Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.
Other Name: Megestrol acetate: Megace




Primary Outcome Measures :
  1. Pathological response rate [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Toxicity evaluation [ Time Frame: up to 2 years after the treatment for each patient ]
  2. Rate of relapse [ Time Frame: up to 2 years after the treatment for each patient ]
  3. Rate of pregnancy [ Time Frame: up to 2 years after the treatment for each patient ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968317


Locations
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China, Shanghai
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai, China, 200011
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Shanghai Changning Maternity & Infant Health Hospital
Shanghai, Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai, China
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Xiaojun Chen
Fudan University
Shanghai 6th People's Hospital
Zhejiang Cancer Hospital
Shanghai Changning Maternity & Infant Health Hospital
Investigators
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Study Chair: Xiaojun Chen, PhD Obstetrics & Gynecology Hospital of Fudan University
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Responsible Party: Xiaojun Chen, Deputy Secretary of the Party committee, Fudan University
ClinicalTrials.gov Identifier: NCT01968317    
Other Study ID Numbers: 134119a4500
First Posted: October 24, 2013    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017
Keywords provided by Xiaojun Chen, Fudan University:
Endometrial Atypical Hyperplasia
Endometrial Adenocarcinoma
Conservative Medication
Additional relevant MeSH terms:
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Adenocarcinoma
Uterine Neoplasms
Hyperplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Metformin
Megestrol
Megestrol Acetate
Hypoglycemic Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants