NCT05080946

Using Aspirin to Improve Immunological Features of Ovarian Tumors

Pilot Study to Assess the Efficacy of Aspirin to Improve Immunological Features of Ovarian Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the effectiveness of aspirin with neoadjuvant chemotherapy for decreasing markers of immune suppression in the tumor at interval debulking surgery, in women with diagnosed ovarian, fallopian tube, or peritoneal carcinoma

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Aspirin 325mg	Participants will receive a tablet of 325mg aspirin that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.
DRUG	Placebo	Participants will receive a placebo tablet that is taken once daily by mouth. Study treatment begins on first day of neoadjuvant chemotherapy for up to 5 "cycles". Participants will be expected to take the study treatment for between 63 and 175 days (3-5 cycles). Participants will stop taking study treatment 7 days prior to participants interval debulking surgery.

Timeline

• Start date: 2021-11-02
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2021-10-18
• Last updated: 2026-04-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study