Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

NCT04008563 | Recruiting

• 1 other identifier: 19-5487
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.

Conditions

Endometrial Cancer; Atypical Hyperplasia; Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved. Patients' reasons for participation or non-participation will be recorded.

  Year 5

Secondary Outcomes (4)

• Completion of Bariatric Surgery

  Year 5

• Loss to Follow-Up Rate

  Year 6

• Completion of Patient Reported Outcome Questionnaires

  Year 5

• Complete Response Rate

  Year 6

Study Arms (2)

Bariatric Surgery and Progestin Intrauterine Device

EXPERIMENTAL

This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.

Procedure: Bariatric Surgery

Progestin Intrauterine Device Alone

NO INTERVENTION

This group will receive a progestin intrauterine device alone.

Interventions

Bariatric Surgery PROCEDURE

Patients who are randomized to the intervention group will receive a progestin intrauterine device and be referred for bariatric service to undergo bariatric surgery within 3 months of their study consent.

Bariatric Surgery and Progestin Intrauterine Device

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI ≥ 35
• Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
• Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by imaging performed (MRI, CT)
• ECOG status \<2
• Desire for fertility preservation
• No contraindications to progestin intrauterine device (IUD)
• Have signed an approved informed consent form

You may not qualify if:

• Evidence of myometrial invasion or extra-uterine disease on imaging
• High grade or p53 endometrial cancer
• History of other malignancies, except if curatively treated with no evidence of disease for \> 5 years
• Current use of weight loss medication. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded.
• Contraindications to sleeve gastrectomy
• Medical co-morbidity with end-organ dysfunction
• Unable to understand and participate in the informed consent process
• Currently pregnant
• Active smoking in ≤6 months
• Active substance use disorder
• Current untreated or severe psychiatric issue

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (1)

• Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

  PMID: 36971688 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Sarah E Ferguson, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Zad

CONTACT

416-946-4501; Tara.Zad@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Group: Bariatric Surgery and Progestin Intrauterine Device (pIUD) Non-Intervention Group: Progestin Intrauterine Device (pIUD) alone Participants who consent will be randomized in a 1:1 allocation.

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 5, 2019
• Study Start: May 14, 2021
• Primary Completion: October 31, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)