LNG-IUD + Semaglutide for Endometrial Cancer
(SWIFT 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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a combination treatment of LNG-IUD, semaglutide, and a structured weight loss program
Follow-up
Participants are monitored for safety and effectiveness after treatment, including 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
Participants will receive a three-component combination intervention consisting of: (1) a levonorgestrel-releasing intrauterine device (LNG-IUD), inserted at baseline; (2) semaglutide 2.4 mg, administered per standard dosing schedule; and (3) a structured weight loss program. Participants will undergo hysteroscopy with endometrial sampling to assess pathological response. Treatment will be administered for 6 months of active intervention, followed by a 6-month follow-up period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
Citations
1.
mdedge.com
mdedge.com/obgyn/article/81864/contraception/does-lng-ius-treat-endometrial-hyperplasia-effectively-mpaDoes 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 ...
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 ...
10.
researchgate.net
researchgate.net/publication/323840642_The_new_levonorgestrelreleasing_intrauterine_systems_Jaydess_and_KyleenaThe 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%) ...
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