Addition of Aspirin to Standard of Care in Oral Cancer

NCT05865548 | Completed Phase 2

• 1 other identifier: HNC02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oral Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Number of participants with treatment-related adverse events as assessed by WHO toxicity criteria

  4 weeks

Secondary Outcomes (2)

• Disease free survival

  through study completion, an average of 2 year

• Overall survival

  through study completion, an average of 2 year

Study Arms (2)

Interventional arm

EXPERIMENTAL

Aspirin 150mg PO daily along with standard of care

Drug: Aspirin 150 mg

Standard of care

ACTIVE COMPARATOR

Standard of care as per the stage of disease and guidelines i.e. Surgery, Surgery with radiation or palliative chemotherapy as per investigators choice

Procedure: Standard of care

Interventions

Aspirin 150 mg DRUG

Aspirin 150 mg PO daily

Interventional arm

Standard of care PROCEDURE

Surgery with or without radiation, palliative chemo as per investigators choice

Also known as: Radiation, chemotherapy

Standard of care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

Location

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Aspirin; Standard of Care; Radiation; Drug Therapy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Physical Phenomena; Therapeutics

Study Officials

• Manoj Pandey

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two arm study comparing standard of care with or without aspirin

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 19, 2023
• Study Start: May 17, 2023
• Primary Completion: August 10, 2024
• Study Completion: August 10, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)