Clinical trial · Interventional
Addition of Aspirin to Standard of Care in Oral Cancer
Randomized Control Trial of Addition of Aspirin to Standard Care in Oral Cancer Patients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin 150 mg | Drug | Aspirin | ALIAS |
| Standard of care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional arm
- description
- Aspirin 150mg PO daily along with standard of care
- interventionNames
- Drug: Aspirin 150 mg
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- Standard of care as per the stage of disease and guidelines i.e. Surgery, Surgery with radiation or palliative chemotherapy as per investigators choice
- interventionNames
- Procedure: Standard of care
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available