Triptorelin for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if triptorelin can protect the ovaries of young females with cancer undergoing certain chemotherapy types that may harm the ovaries. Triptorelin temporarily pauses ovarian activity, potentially reducing future fertility issues. Participants will either receive triptorelin before chemotherapy or follow the usual care without it. Females under 40 who have started menstruating, are newly diagnosed with cancer (excluding breast cancer), and are about to begin chemotherapy might be eligible. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that oral and other hormonal contraceptive use is not an exclusion, and there are restrictions on certain therapies during the study. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that triptorelin is likely to be safe for humans?
Research has shown that triptorelin is generally safe for patients. In past studies, many individuals have used triptorelin without experiencing serious side effects. For instance, one study found that 85.3% of patients continued using triptorelin for a year, indicating that most do not encounter severe problems with the treatment.
Some side effects can occur, such as reactions at the injection site or changes in hormone levels. However, these are usually not serious.
Triptorelin is already used for other conditions, like prostate cancer, further suggesting its safety. While reports of side effects exist, they often relate to the progression of the underlying condition rather than the drug itself.
Overall, triptorelin appears to have a safety profile similar to its use in other treatments.12345Why do researchers think this study treatment might be promising?
Triptorelin is unique because it acts as a hormone therapy that targets and suppresses the production of certain hormones that can fuel cancer growth, offering a different approach compared to traditional chemotherapy. Unlike standard chemotherapy, which often attacks rapidly dividing cells indiscriminately, triptorelin specifically reduces hormone levels, potentially minimizing some of the side effects associated with chemotherapy. Researchers are excited about triptorelin because it could effectively complement existing treatments, potentially improving outcomes for patients by providing a more targeted intervention.
What evidence suggests that triptorelin might be an effective treatment for preventing ovarian damage in cancer patients?
Research has shown that triptorelin, which participants in this trial may receive, can help protect the ovaries during chemotherapy. It temporarily halts the ovaries' normal functions, potentially reducing the risk of damage from chemotherapy drugs, particularly alkylating agents. In past studies, triptorelin proved very effective, with 97.6% of patients achieving the desired results. By reducing hormone levels, this treatment may help preserve fertility in young cancer patients. This makes triptorelin a promising option for those concerned about ovarian damage from chemotherapy.24567
Who Is on the Research Team?
Eric J Chow
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for post-menarchal females under 40 years old, diagnosed with their first cancer (excluding breast cancer), who will receive chemotherapy including alkylating agents. They must have had their first menstrual period over 6 months ago and agree to consent forms. It's not suitable for those who don't meet these criteria or can't follow the study requirements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive triptorelin intramuscularly up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of ovarian reserve and hormone levels up to 2 years post-chemotherapy.
What Are the Treatments Tested in This Trial?
Interventions
- Triptorelin
Trial Overview
The trial tests if Triptorelin can prevent ovarian damage in young female cancer patients during chemotherapy. Participants are either given Triptorelin or no treatment as a comparison, alongside standard chemo with alkylating agents known to affect ovaries.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive triptorelin IM up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study.
Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
Citations
An Update on Triptorelin: Current Thinking on Androgen ...
In this study, PSA levels were also reduced from baseline by 64.2% and 96.0% at 4 and 26 weeks after injection, with median PSA levels below 4 ng/ml from week ...
Triptorelin associated adverse events evaluated using ...
This study aimed to characterize the real-world adverse event(AE) profile associated with triptorelin using data from the FDA Adverse Event ...
Study Results | NCT05458856 | Effects of Triptorelin When ...
This Phase III, multicenter, open-label, single arm study was conducted at 26 investigational sites in 6 countries from 30-Aug-2022 to 08-Jul-2024 in ...
Testosterone nadir and clinical outcomes in patients with ...
Pooled data from nine prospective studies showed that 80%–90% of patients with advanced prostate cancer reached testosterone levels <0.7 nmol/L ...
Effectiveness, pharmacokinetics, and safety of triptorelin ...
The proportion of successful patients out of the total number of patients was 97.6% (122/125), confirming the study's primary endpoint. The ...
6.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov/41122488/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0dLg-xHE8UCB_GUYN8mwTcaNO81zqEBp00z8jtcfNrs&fc=None&ff=20251023144925&v=2.18.0.post22+67771e2Treatment of aggressive prostate cancer with triptorelin in ...
Overall, 85.3% (95% confidence interval (82.6, 87.7)) of patients received a continuous 12-month treatment with triptorelin, and 69.1% of ...
CLINICAL STUDY RESULTS
Overall, the results suggest that triptorelin 6-month formulation injected under the skin keeps testosterone levels low in participants with ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.