Addition of Aspirin to Standard of Care in Oral Cancer

• Status: Not yet recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Despite accumulating evidence of the benefit of aspirin in cancer, its effect on improving cancer survival is still debated since the mechanism by which it impacts cancer survival is not completely understood and the published data are discordant. There have been 4 randomized controlled trials (RCT) showing mixed results from no effect to improved survival. Several retrospective and observational studies have reported a survival advantage of adding aspirin to the treatment for various cancers. A meta-analysis of 118 studies, 63 of them specifically reporting on cancer mortality and the rest on all-cause mortality, found a 21% reduction in cancer deaths and about 20% reduction in all-cause mortality (pooled hazard ratio (HR): 0.79; 95% confidence intervals: 0.73, 0.84).

However, the evidence is still lacking and there is need to do more RCT

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banaras Hindu University
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• All Histologically proven cases of primary oral cancers.

• Stage T1 to T4, N0 to N3, M0 to M1.

• Age above 18.

• Karnofsky' performance status more than 70, ECOG 0 to 2

• Hb >8.0 gm/dL

• Total count >4000 cu mm

• Platelet count >100000 Serum creatinine <1.0mg

• Liver enzymes up to 1.5 times normal

• Bilirubin <1.0mg

Exclusion Criteria:

• Patients with acid peptic disease

• Pregnant and lactating women.

• Patients not willing to participate.

• Patients with known allergy to NSAID

• Patients with Asthma, rhinitis and nasal polyps

• Presence of viral fever

• Use of any other blood thinner like warfarin, heparin or low molecular weight heparin

• bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count)

• pyruvate kinase or G6PD deficiency

• Patients receiving mifepristone, acetazolamide, corticosteroids, dichlorphenamide, methotrexate, valproic acid, herbal medications (such as ginkgo biloba)

• Patients with recent history of anti-viral vaccines