Aspirin for Testicular Cancer

(ASPIRE Trial)

Recruiting at 1 trial location

Overseen By Alicia Patrick

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must be taking: Cisplatin-based chemotherapy, Aspirin

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Prior VTE/PE, ASA allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to the 6-month Venous Thromboembolism (VTE)-free rate in participants with advanced germ cell cancer at high risk of VTE who are receiving standard of care cisplatin-based chemotherapy and low-dose acetylsalicylic acid (ASA) and compare to relevant historical controls

Will I have to stop taking my current medications?

If you are currently taking anticoagulation or antiplatelet therapy, you will need to stop these medications to participate in the trial. However, using non-steroidal anti-inflammatory drugs (NSAIDs) for pain is allowed.

Is aspirin generally safe for humans?

Aspirin, also known as low-dose ASA, is commonly used for its blood-thinning properties and has been studied extensively for various conditions. It is generally considered safe for most people when used as directed, but it can cause side effects like stomach upset or bleeding, especially at higher doses or with long-term use. ^{1 2 3 4 5}

How does low-dose aspirin differ from other treatments for testicular cancer?

Low-dose aspirin is unique for testicular cancer as it is not a standard treatment like surgery, radiotherapy, or chemotherapy. It may offer a novel approach by potentially reducing inflammation or affecting blood clotting, which are not the primary targets of traditional treatments. ^{5 6 7 8 9}

Research Team

Landon Brown, MD

Principal Investigator

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with advanced germ cell tumors, including testicular cancer and certain rare embryonal tumors, who are at high risk of developing blood clots (VTE) while receiving standard chemotherapy.

Inclusion Criteria

I can swallow pills.

My cancer is confirmed as testicular or germ cell, stage IS or higher.

Written informed consent and HIPAA authorization for release of personal health information

Exclusion Criteria

Allergy to ASA

I have had a blood clot in the past.

I am receiving chemotherapy after surgery to remove my cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care cisplatin-based chemotherapy and self-administer low-dose ASA (81 mg) daily for 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of VTE-free status and survival outcomes

2 years

Treatment Details

Interventions

• Low-dose ASA

Trial Overview The study tests if low-dose acetylsalicylic acid (ASA), commonly known as aspirin, can prevent blood clots in these patients over a period of 6 months compared to past data from similar patients not given ASA.

Participant Groups

Group I: Low-dose aspirin (acetylsalicylic acid [ASA]) Experimental Treatment 1 Intervention

ASA has been shown to reduce risk of VTE. It will be self-administered, a fixed dose of ASA (81 mg) by mouth daily for 26 weeks.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health Wake Forest Baptist

Collaborator

Trials

3

Recruited

250+

References

1. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Disease Mortality After Chemotherapy or Surgery for Testicular Nonseminoma: A Population-Based Study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Thromboembolic Events During Treatment with Cisplatin-based Chemotherapy in Metastatic Testicular Germ-cell Cancer 2000-2014: A Population-based Cohort Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Testicular cancer in young Norwegians. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Predictors of thrombosis in testicular cancer during platinum-based chemotherapy. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Thromboprophylaxis and the route of administration of chemotherapy in testicular cancer patients in German-speaking countries. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

[Seminona of stage I: strategies compared]. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Detection of early ototoxic effect in testicular-cancer patients treated with cisplatin by transiently evoked otoacoustic emission: a pilot study. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Changing management of clinical low-stage testicular cancer. [2018]

9. France pubmed.ncbi.nlm.nih.gov

[Metastatic pure seminomas of the testicle: role of chemotherapy]. [2009]