LNG-IUD + Semaglutide for Endometrial Cancer

(SWIFT Trial)

Not yet recruiting at 3 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: The Methodist Hospital Research Institute
Must be taking: LNG-IUD, Semaglutide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for women with early-stage endometrial cancer or atypical hyperplasia who wish to preserve fertility. The treatment combines a hormonal IUD (LNG-IUD), semaglutide, and a weight loss program to assess its effectiveness. The trial aims to determine the number of participants achieving a complete response, the duration of this response, and the impact on weight and quality of life. Suitable candidates have a confirmed diagnosis, desire to preserve fertility, and meet specific weight criteria or have related health issues like diabetes or sleep apnea. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have examined the safety of both the LNG-IUD and semaglutide, yielding encouraging results. The LNG-IUD effectively provides birth control and offers additional health benefits, such as reducing heavy periods. Some research even shows it can completely reverse certain conditions, indicating its efficacy without causing serious harm.

Semaglutide has undergone extensive study and is considered safe for weight management and improving overall health. Large studies have shown it does not increase cancer risk, which is reassuring. In fact, semaglutide is associated with a lower risk of some cancers and fewer hospital visits, making it a well-tolerated choice for many people.

Overall, previous studies have shown both treatments in this trial to be safe and well-tolerated, which is a positive sign for their combined use.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment combination for endometrial cancer because it offers a novel, fertility-sparing approach. Unlike traditional treatments like surgery or hormone therapy alone, this approach combines a levonorgestrel-releasing intrauterine device (LNG-IUD) with semaglutide, a medication typically used for weight management and diabetes, along with a structured weight loss program. This combination aims not only to treat the cancer but also to improve overall health and preserve fertility, which is a significant concern for many patients. Additionally, semaglutide introduces a new mechanism of action by helping with weight loss, which can further support cancer treatment and potentially improve outcomes.

What evidence suggests that this combination treatment could be effective for endometrial cancer?

Research has shown that the LNG-IUD, a hormonal device placed in the uterus, effectively treats endometrial hyperplasia. One study found a 100% success rate after six months. Semaglutide, a medication known for aiding weight loss and improving metabolic health, may also benefit conditions affecting the uterine lining. In this trial, participants will receive a combination of the LNG-IUD and semaglutide, along with a structured weight loss program, to explore their combined effects on early-stage endometrial cancer while preserving fertility. Initial findings suggest that the LNG-IUD can reverse abnormal cell growth in the uterine lining, and semaglutide might enhance these effects by improving overall health. This combination could increase the chances of completely eliminating the disease after treatment.678910

Who Is on the Research Team?

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Aparna A. Kamat, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for women of reproductive age who have endometrial atypical hyperplasia or early-stage (grade 1) endometrial cancer and want to keep their ability to have children. Participants should also be overweight or obese.

Inclusion Criteria

Metabolic profile: BMI ≥ 30 kg/m², or BMI 27-29.9 kg/m² with at least one weight-related comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease)
Treatment rationale: Medical inoperability due to Class III obesity (BMI ≥40 kg/m²) or ASA Physical Status Classification score ≥3
I have been diagnosed with early-stage endometrial cancer or atypical hyperplasia.
See 4 more

Exclusion Criteria

Positive pregnancy test at screening
I am under 18 years old.
Inability to provide written informed consent or comply with study procedures
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combination treatment of LNG-IUD, semaglutide, and a structured weight loss program

6 months
Regular visits for treatment administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 6 and 12 months

6 months
Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • LNG-IUD
  • Semaglutide
  • Structured Weight Loss Program

Trial Overview

The study tests a combination of three treatments: a hormonal IUD (LNG-IUD), weekly semaglutide injections, and a structured weight loss program. The goal is to see if this approach can treat the condition while preserving fertility.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Combination Fertility-Sparing TreatmentExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Citations

Does the LNG-IUS treat endometrial hyperplasia as ...

After 6 months, women in the LNG-IUS arm had a 100% response rate, compared with 96% for the continuous MPA group and 69% for cyclic MPA.

levonorgestrel-intrauterine-device-and-preservation-of- ...

We report the case of a 43 years old patient, nulliparous, diagnosed by directed biopsy guided by hysteroscopy of grade (G)1 endometrial cancer ...

Medically unfit women with early-stage endometrial cancer ...

To assess the clinical efficacy of the levonorgestrel intrauterine system (LNG-IUS) in the treatment of early-stage endometrial cancer in elderly morbidly obese ...

LNG-IUS may have potential in endometrial cancer

LNG-IUS may have potential in endometrial cancer. Insertion of a levonorgestrel intrauterine system (LNG-IUS) can reverse abnormal endometrial cell growth, ...

(PDF) Levonorgestrel Intrauterine Device and Preservation ...

IUD-LNG placement, showed complete regression of the adenocarcinoma. Levonorgestrel Intrauterine Device and Preservation of Fertility in Endometrial Cancer ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33022448/

Conservatively treated endometrial intraepithelial neoplasia ...

LngIUD was associated with a nonsignificant 46 % decrease in the odds of IS (OR: 0.54, p = 0.66, CI: 0.08-2.87). Twenty-two women attempted ...

Levonorgestrel-Releasing Intrauterine Device Use in ...

All patients reported significant improvement in HMB after LNgIUD placement and 60% achieved amenorrhea, with mean time to improvement of 94 ± 69 days. Mean ...

Dr. José Luis Neyro

The oral progestins achieve #regression rates of around 85% and the #LNGIUD achieves up to #100percent. link.springer.com/article/10.100…

DOI

Abstract. Introduction: The association between the use of hormonal contraception and breast cancer has been debated in the medical community ...

The new levonorgestrelreleasing intrauterine systems ...

We assessed four-year pregnancy rates (by Pearl Index and life-table analysis) and safety outcomes. RESULTS: Successful IUS placement occurred in 1,568 (98%) ...