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Addition of Aspirin to Standard of Care in Oral Cancer

Primary Purpose

Oral Cancer

Status
Recruiting
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Aspirin 150 mg
Standard of care
Sponsored by
Banaras Hindu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Cancer

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banaras Hindu UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional arm

Standard of care

Arm Description

Aspirin 150mg PO daily along with standard of care

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease free survival
Local recurrence or metastasis from the time from the diagnosis to the closer of study
Overall survival
Death from the time of diagnosis to closer of study

Full Information

First Posted
April 28, 2023
Last Updated
May 23, 2023
Sponsor
Banaras Hindu University
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1. Study Identification

Unique Protocol Identification Number
NCT05865548
Brief Title
Addition of Aspirin to Standard of Care in Oral Cancer
Official Title
Randomized Control Trial of Addition of Aspirin to Standard Care in Oral Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Banaras Hindu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Aspirin (ASA), an NSAID, is a well-known antipyretic and analgesic agent and is used to prevent recurrent transient ischemic attacks or strokes. In addition to its classical anti- inflammatory function, clinical and epidemiological studies indicate that aspirin can be used as a preventive or therapeutic agent in multiple cancers, including oral cancers While the exact mechanism through which NSAIDs contribute to chemo prevention is not completely understood, Aspirin inhibits the enzyme Cox; Cox-1 and Cox-2 are well characterized. Cox converts a arachidonic acid to prostaglandin H2, which in turn produces biologically active prostaglandins that influence path physiological processes in a range of tissues including angiogenesis, apoptosis, cell proliferation and migration, inflammatory response and thrombosis. Inhibition of prostaglandin synthesis is considered the pre dominant mechanism by which NSAIDs act as anti-inflammatory agents, but it is unclear whether the anti-cancer properties of these agents can be solely attributed to Cox inhibition. Recently, Cox-2 over expression has been identified in a number of different malignancies and it has been hypothesized that Cox-2 prostaglandins promote tumor genesis by inhibiting apoptosis, modulating the immune system and regulating tumor associated angiogenesis. A detailed search of literature and bio informatics analysis of the data obtained showed that the effect of Aspirin on survival and prevention of recurrence and secondary cancer could be due to its effect on following 11 genes PTGS2, PIK3CA, PARP1, PARP2, VEGFA, KDR, PTGES2, NFKB1, P53, FLT1, VEGFR. These genes not only interact and control each other but also control cell cycle regulation through other genes as shown below. These could be due to co expression, physical interactions, shared domains or predicted interactions in absence of data. Based on the gene-gene and protein-protein interactions they can be clustered into three with PTGES2, PTGS2 and p53 being in first cluster (figure 2 below), the NGS data obtained from the previous patients also showed the p53 to be the primary driver gene (unpublished data, submitted) in nearly 50% of the subjects. It has also been shown that patients with p53 mutations have poor survival and increased recurrence rates compared to those without p53 mutations. This coupled with literature showing improved survival and low recurrence in patients receiving Aspirin suggest the need for a RCT as this has never been done before.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Two arm study comparing standard of care with or without aspirin
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional arm
Arm Type
Experimental
Arm Description
Aspirin 150mg PO daily along with standard of care
Arm Title
Standard of care
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Aspirin 150 mg
Intervention Description
Aspirin 150 mg PO daily
Intervention Type
Procedure
Intervention Name(s)
Standard of care
Other Intervention Name(s)
Radiation, chemotherapy
Intervention Description
Surgery with or without radiation, palliative chemo as per investigators choice
Primary Outcome Measure Information:
Title
Adverse events
Description
Number of participants with treatment-related adverse events as assessed by WHO toxicity criteria
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Local recurrence or metastasis from the time from the diagnosis to the closer of study
Time Frame
through study completion, an average of 2 year
Title
Overall survival
Description
Death from the time of diagnosis to closer of study
Time Frame
through study completion, an average of 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manoj Pandey
Email
mpandey66@bhu.ac.in
First Name & Middle Initial & Last Name or Official Title & Degree
Sumith Lal
Phone
915422361014
Email
slalmilka00@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Pandey
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banaras Hindu University
City
Varanasi
State/Province
UP
ZIP/Postal Code
221005
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Pandey, MS, PhD
Phone
2361014
Email
mpandey66@bhu.ac.in
First Name & Middle Initial & Last Name & Degree
Manoj Pandey, MS, PhD
Email
mpandey66@bhu.ac.in

12. IPD Sharing Statement

Plan to Share IPD
No

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Addition of Aspirin to Standard of Care in Oral Cancer

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