Oral CancerPhase 2/3NCT05865548
Addition of Aspirin to Standard of Care in Oral Cancer
A Phase 2/3 study testing Aspirin 150 mg in people with Oral Cancer, run by Banaras Hindu University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Aspirin 150 mg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 17 May 2023to 10 Aug 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Platelet count >100000 Serum creatinine <1.0mg
- Liver enzymes up to 1.5 times normal
- Bilirubin <1.0mg
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Addition of Aspirin to Standard Care in Oral Cancer Patients.
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
Read the 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.
- Conditions
- Oral Cancer
- Being tested
- Aspirin 150 mg, Standard of care
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 150 mgDrug
Aspirin 150 mg PO daily
Standard of careProcedure or surgery
Also called Radiation, chemotherapy
Surgery with or without radiation, palliative chemo as per investigators choice
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Aspirin 150mg PO daily along with standard of care Receives: 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 Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of participants with treatment-related adverse events as assessed by WHO toxicity criteria
Measured: 4 weeks
Secondary outcomes (2)
Disease free survival
Local recurrence or metastasis from the time from the diagnosis to the closer of study
Measured: through study completion, an average of 2 year
Overall survival
Death from the time of diagnosis to closer of study
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start17 May 2023
- Primary completion10 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm study comparing standard of care with or without aspirin
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manoj Pandey, Banaras Hindu University
- Investigators
- Manoj Pandey, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865548
- Sponsor's protocol ID
- HNC02
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Addition of Aspirin to Standard Care in Oral Cancer Patients.
- ClinicalTrials.gov ID
- NCT05865548
- Acronym / sponsor ID
- HNC02
- Conditions
- Oral Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 10 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arm study comparing standard of care with or without aspirin
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Drug: Aspirin 150 mgAspirin 150mg PO daily along with standard of care |
| Standard of care | Active comparator | Procedure: Standard of careStandard of care as per the stage of disease and guidelines i.e. Surgery, Surgery with radiation or palliative chemotherapy as per investigators choice |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 150 mgAspirin 150 mg PO daily | Drug | Interventional arm |
| Standard of careAlso: Radiation, chemotherapySurgery with or without radiation, palliative chemo as per investigators choice | Procedure or surgery | Standard of care |
Primary outcome
Adverse events
Time frame: 4 weeks
Number of participants with treatment-related adverse events as assessed by WHO toxicity criteria
2 secondary outcomes
Disease free survival
Time frame: through study completion, an average of 2 year
Overall survival
Time frame: through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Pandey principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aspirin 150 mg in people with Oral Cancer, run by Banaras Hindu University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.