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The Effect of Neoadjuvant DMPA on Glandular Cellularity in Women Awaiting Hysterectomy

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ClinicalTrials.gov Identifier: NCT02335203
Recruitment Status : Unknown
Verified September 2016 by Stephen Fiascone, M.D., Women and Infants Hospital of Rhode Island.
Recruitment status was:  Active, not recruiting
First Posted : January 9, 2015
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Stephen Fiascone, M.D., Women and Infants Hospital of Rhode Island

Brief Summary:

Objective: To compare pre- and post-treatment glandular cellularity in women with complex atypical hyperplasia or grade 1-2 endometrial adenocarcinoma who are treated with intramuscular depot medroxyprogesterone acetate (DMPA) versus placebo injection prior to hysterectomy. The secondary objective is to compare various other outcomes including molecular, histologic, pathologic and clinical endpoints in women treated with DMPA versus placebo prior to hysterectomy.

Hypothesis: Patients treated with DMPA will have significantly decreased glandular cellularity post-treatment when compared to patients treated with placebo injection. Patients treated with DMPA will exhibit previously described changes in molecular tumor marker expression patterns and other characteristic histologic changes. Patients treated with DMPA will report less bothersome vaginal bleeding prior to surgery when compared to patients treated with placebo injection.

Study Design: Double blinded randomized controlled trial

Population: Women being treated at the Women and Infants Program in Women's Oncology who have a biopsy-proven diagnosis of complex atypical hyperplasia or grade 1-2 endometrial adenocarcinoma with disease clinically confined to the uterus, with a plan to undergo hysterectomy.

Study Period: February 2015 to June 2016


Condition or disease Intervention/treatment Phase
Grade 1 Endometrial Endometrioid Adenocarcinoma Grade 2 Endometrial Endometrioid Adenocarcinoma Complex Atypical Endometrial Hyperplasia Drug: Depot medroxyprogesterone acetate Other: Placebo Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Neoadjuvant Depot Medroxyprogesterone Acetate on Glandular Cellularity in Women With Complex Atypical Hyperplasia or Grade 1-2 Endometrial Adenocarcinoma Awaiting Hysterectomy
Study Start Date : February 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Depot medroxyprogesterone acetate
Women randomized to receive one intramuscular injection of 400mg depot medroxyprogesterone acetate prior to hysterectomy.
Drug: Depot medroxyprogesterone acetate
One injection intragluteally of 400mg depot medroxyprogesterone acetate at the time of the patient's first visit with the Program in Womens' Oncology
Other Names:
  • Depo Provera
  • DMPA

Placebo Comparator: Placebo injection
Women randomized to receive one intramuscular injection of 1mL normal saline prior to hysterectomy.
Other: Placebo
One injection intragluteally of 1mL Normal Saline (0.9% Sodium Chloride) at the time of the patient's first visit with the Program in Womens' Oncology
Other Name: 0.9% Sodium Chloride




Primary Outcome Measures :
  1. Change in glandular cellularity [ Time Frame: 2-3 weeks after hysterectomy ]
    Histologic analysis of glandular cellularity in hysterectomy specimens as compared to pre-hysterectomy endometrial tissue


Secondary Outcome Measures :
  1. Change in mitotic index [ Time Frame: 2-3 weeks after hysterectomy ]
    Histologic analysis of mitotic index in hysterectomy specimens as compared to pre-hysterectomy endometrial tissue

  2. Histologic grade [ Time Frame: 2-3 weeks after hysterectomy ]
    Histologic analysis of tumor grade in hysterectomy specimens

  3. Depth of invasion [ Time Frame: 2-3 weeks after hysterectomy ]
    Pathologic analysis of depth of invasion in hysterectomy specimens

  4. Tumor size [ Time Frame: 2-3 weeks after hysterectomy ]
    Pathologic analysis of tumor size in hysterectomy specimens

  5. Lymph node involvement [ Time Frame: 2-3 weeks after hysterectomy ]
    Pathologic analysis of lymph node involvement in surgical specimens

  6. Lymphovascular invasion [ Time Frame: 2-3 weeks after hysterectomy ]
    Pathologic analysis of lymphovascular invasion in surgical specimens

  7. Estrogen Receptor immunohistochemistry analysis [ Time Frame: 2-3 weeks after hysterectomy ]
    Immunohistochemical analysis of Estrogen Receptor status in tumor specimen

  8. Progesterone Receptor immunohistochemistry analysis [ Time Frame: 2-3 weeks after hysterectomy ]
    Immunohistochemical analysis of Progesterone Receptor status in tumor specimen

  9. Progesterone Receptor Beta immunohistochemistry analysis [ Time Frame: 2-3 weeks after hysterectomy ]
    Immunohistochemical analysis of Progesterone Receptor Beta status in tumor specimen

  10. B-Cell-Lymphoma-2 immunohistochemistry analysis [ Time Frame: 2-3 weeks after hysterectomy ]
    Immunohistochemical analysis of BCL2 status in tumor specimen

  11. Ki-67 immunohistochemistry analysis [ Time Frame: 2-3 weeks after hysterectomy ]
    Immunohistochemical analysis of Ki-67 status in tumor specimen

  12. Caspase-3 immunohistochemistry analysis [ Time Frame: 2-3 weeks after hysterectomy ]
    Immunohistochemical analysis of Casp3 status in tumor specimen

  13. Phospho-Histone-H3 immunohistochemistry analysis [ Time Frame: 2-3 weeks after hysterectomy ]
    Immunohistochemical analysis of PHH3 status in tumor specimen

  14. Functional Assessment of Cancer Therapy - Endometrial cancer version [ Time Frame: 1-2 hours prior to hysterectomy ]
    Quality of life survey FACT-En, administered 1-2 hours prior to surgery

  15. Hemoglobin level [ Time Frame: 12-24 hours after hysterectomy ]
    Hemoglobin level drawn 12-24 hours after hysterectomy to evaluate if DMPA improves blood count via diminished bleeding

  16. Final cancer stage [ Time Frame: 2-3 weeks after hysterectomy ]
    Pathologic determination of patient's definitive stage of endometrial cancer per FIGO guidelines



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient at the Women and Infants Program in Women's Oncology
  • Biopsy-proven complex atypical hyperplasia or grade 1 or grade 2 endometrial adenocarcinoma with endometrioid histology
  • Disease clinically confined to the uterus (no physical exam findings or imaging to suggest extrauterine disease)
  • Ages 18 and older
  • Plan for hysterectomy at Women and Infants Hospital of Rhode Island
  • Able to read English or Spanish
  • Able to give informed consent for involvement in the study

Exclusion Criteria:

  • Allergic to medroxyprogesterone acetate
  • Known sensitivity to any component of depot medroxyprogesterone acetate
  • History of breast cancer, hepatic disease, uncontrolled hypertension, osteoporosis or strong osteoporotic risk factors including anorexia nervosa, rheumatoid arthritis and chronic glucocorticoid use
  • Treatment with any progesterone or progesterone analogue in past 12 months

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): NCT02335203


Locations
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United States, Rhode Island
Women and Infants Hospital, Program in Women's Oncology
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
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Principal Investigator: Stephen Fiascone, MD Department of Medical Education

Publications:

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Responsible Party: Stephen Fiascone, M.D., MD in Department of Medical Education; OB/GYN Residency Program, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02335203     History of Changes
Other Study ID Numbers: 14-0099
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma, Endometrioid
Endometrial Hyperplasia
Hyperplasia
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Uterine Diseases
Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male