Aspirin for Testicular Cancer

(ASPIRE Trial)

Recruiting at 1 trial location

Overseen By Margarita Dzhanumova

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if low-dose aspirin (also known as low-dose ASA) can prevent blood clots in individuals with advanced testicular cancer receiving standard chemotherapy. The study focuses on those at high risk for blood clots during treatment. Participants should have advanced testicular cancer and be starting or have recently started cisplatin-based chemotherapy. The trial seeks to assess whether adding aspirin can improve outcomes compared to past patients who did not take it. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

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 there any evidence suggesting that low-dose ASA is likely to be safe for humans?

Research has shown that low-dose aspirin, also known as ASA, is generally safe for use. A large study with over 118,000 participants found that taking low-dose aspirin helped protect against certain types of cancer, suggesting long-term use is safe for many people. Another study found that those who took a daily low dose of aspirin were much less likely to experience cancer recurrence compared to those who did not.

As this is a Phase 2 trial, earlier studies have already provided evidence that aspirin is safe for humans. While all medicines can have side effects, the widespread and well-known use of low-dose aspirin offers some reassurance about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for testicular cancer?

Unlike the standard treatments for testicular cancer, which typically involve chemotherapy, radiation, or surgery, low-dose aspirin (ASA) presents a unique approach by potentially reducing the risk of venous thromboembolism (VTE). Aspirin is well-known for its anti-inflammatory and anticoagulant properties, which could offer additional benefits alongside traditional cancer treatments. Researchers are excited about this treatment because it is easy to administer—just a daily 81 mg pill—and it has a well-established safety profile, making it an accessible option with minimal side effects. This approach could enhance the quality of life for patients by potentially preventing complications without adding significant treatment burdens.

What evidence suggests that low-dose ASA might be an effective treatment for VTE in testicular cancer?

Studies have shown that taking low-dose aspirin, also known as ASA, can lower the risk of venous thromboembolism (VTE), or blood clots in the veins. This is particularly important for people with advanced germ cell cancer, as they have a higher chance of developing these clots, especially during chemotherapy. Research suggests that a small daily dose of aspirin may help prevent these clots. While aspirin is often recognized for its heart health benefits, it also reduces cancer-related risks like VTE. Evidence indicates that aspirin could be effective in this situation. Participants in this trial will receive a fixed dose of low-dose aspirin (81 mg) daily for 26 weeks to evaluate its effectiveness in reducing VTE risk. ^{1 2 6 7 8}

Who Is on the Research Team?

Landon Brown, MD

Principal Investigator

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Atrium Health Wake Forest Baptist

Collaborator

Citations

1. withpower.com withpower.com/trial/phase-2-thromboembolism-4-2025-4ccdf

Aspirin for Testicular Cancer (ASPIRE Trial) 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37966913/

Long-term aspirin use and cancer risk: a 20-year cohort study Long-term low-dose aspirin use was associated with slight to moderately reduced risks for several cancers but not for cancer overall.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06866964

Study Details | NCT06866964 | A Single-arm, Phase II ... 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. Other Names: aspirin.

4. news.cancerresearchuk.org news.cancerresearchuk.org/2014/08/06/aspirin-and-cancer-not-quite-but-nearly/

Aspirin and cancer – not quite, but nearly - Cancer News It confirms that aspirin protects most strongly against bowel, stomach and oesophageal cancers, and also more weakly against lung, prostate and breast cancers.

5. researchgate.net researchgate.net/publication/329852578_Long-term_use_of_low-dose_aspirin_for_cancer_prevention_A_10-year_population_cohort_study_in_Hong_Kong

Long‐term use of low‐dose aspirin for cancer prevention Compared with patients who had not been prescribed aspirin, aspirin usage led to significant reduction of cancers in liver (RR: 0.49), stomach (RR: 0.42), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8279749/

Aspirin Use and Common Cancer Risk: A Meta-Analysis ... New research has reinforced the idea that long-term low-dose aspirin intake may inhibit cancer cell proliferation and metastasis (12, 13). Findings from ...

7. cancer.org cancer.org/cancer/latest-news/can-aspirin-help-reduce-your-cancer-risk.html

Can Aspirin Help Reduce Your Cancer Risk? Researchers found that the people taking a daily low dose of aspirin were 55% less likely to have their cancer come back than those who did not take daily ...

8. physiciansweekly.com physiciansweekly.com/post/low-dose-acetylsalicylic-acid-for-cancer-prevention-considering-risk-factors-a-retrospective-cohort-study

Low-dose acetylsalicylic acid for cancer prevention ... Of 118,548 participants, 15,793 consumed aspirin, and 4,003 had cancer. Results indicated a significant protective effect of aspirin against ...