Oral CancerNCT07606638
Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients
A study testing Tramadol and Pregabalin + Naproxen Sodium in people with Oral Cancer and Oral Cavity Cancer, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
This randomized clinical study was designed to compare two pain treatment approaches for adults with oral cancer who had moderate to severe pain. Oral cancer pain may occur because of tumor growth, local tissue damage, inflammation, ulceration, or nerve involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Oral Cavity Cancer, Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Tramadol and Pregabalin + Naproxen Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Histopathology confirmed diagnosis of oral cancer
- Experiencing moderate to severe pain (VAS ≥ 4)
- Either opioid-naïve or off opioids for at least one week
- Able to provide informed consent
Who cannot join
- Known allergy to morphine, pregabalin, or NSAIDs
- History of renal impairment, gastrointestinal bleeding, or peptic ulcer disease
- Concurrent use of other strong analgesics
- Psychiatric illness or cognitive impairment interfering with pain assessment
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This randomized clinical study was designed to compare two pain treatment approaches for adults with oral cancer who had moderate to severe pain. Oral cancer pain may occur because of tumor growth, local tissue damage, inflammation, ulceration, or nerve involvement. Standard pain treatment often includes opioid medicines, but these medicines may cause side effects such as sedation, nausea, constipation, dizziness, tolerance, or dependence. In some patients, pain may also have a nerve-related or inflammatory component, where medicines such as pregabalin and naproxen sodium may provide additional benefit.
A total of 98 eligible adult patients with histopathology-confirmed oral cancer and a baseline Visual Analog Scale pain score of 4 or more were included. Patients were randomly assigned into two treatment groups. One group received oral tramadol 50 mg every 4 hours, with dose adjustment according to pain relief and tolerability. The other group received oral pregabalin 75 mg twice daily with naproxen sodium 550 mg twice daily. Both treatments were given for 7 days under clinical monitoring.
Pain intensity was measured using the Visual Analog Scale at baseline, day 3, and day 7. The main outcome was the mean reduction in pain score from baseline to day 7. Effective pain relief was defined as at least 50% reduction in the baseline pain score after 7 days of treatment. Side effects such as sedation, nausea or vomiting, constipation, dizziness, and gastrointestinal discomfort were also recorded. Patient satisfaction with pain control was assessed at the end of treatment.
- Being tested
- Tramadol, Pregabalin + Naproxen Sodium
- Keywords
- Oral cancer pain, Cancer pain management, Oral cavity neoplasms, Mouth neoplasms, Oral squamous cell carcinoma
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Oral tramadol 50 mg was administered every 4 hours for 7 days. Dose adjustment was made according to clinical response and tolerability.
Pregabalin + Naproxen SodiumDrug
Oral pregabalin 75 mg was administered twice daily for 7 days. Oral naproxen sodium 550 mg was administered twice daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A Tramadol | Active comparator | Received oral tramadol 50 mg every 4 hours for pain management. Dose titration was done according to pain relief and tolerability. Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects. Receives: Drug: Tramadol |
| Group B Pregabalin Plus Naproxen Sodium | Experimental | Received oral pregabalin 75 mg twice daily along with oral naproxen sodium 550 mg twice daily for pain management. Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects. Receives: Drug: Pregabalin + Naproxen Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7
Pain intensity was assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain. The mean change in pain score was calculated by subtracting the day 7 Visual Analog Scale score from the baseline Visual Analog Scale score. A greater positive change indicated greater reduction in pain intensity. The mean change was compared between the tramadol group and the pregabalin plus naproxen sodium group.
Measured: Baseline and Day 7
Secondary outcomes (2)
Effective Pain Relief at Day 7
Effective pain relief was defined as at least 50% reduction in the baseline Visual Analog Scale pain score after 7 days of treatment. The proportion of participants achieving effective pain relief was compared between the two treatment groups.
Measured: Baseline to Day 7
Severity of Adverse Events
The severity of adverse events was assessed using the Common Terminology Criteria for Adverse Events version 5.0. Events were categorized according to severity grade and compared between the treatment groups.
Measured: Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Feb 2026
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Rooshan Tahir Qazi, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606638
- Sponsor's protocol ID
- Mayo6
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer Patients
- ClinicalTrials.gov ID
- NCT07606638
- Acronym / sponsor ID
- Mayo6
- Keywords
- Oral cancer pain, Cancer pain management, Oral cavity neoplasms, Mouth neoplasms, Oral squamous cell carcinoma
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 26 May 2026 (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.
This randomized clinical study was designed to compare two pain treatment approaches for adults with oral cancer who had moderate to severe pain. Oral cancer pain may occur because of tumor growth, local tissue damage, inflammation, ulceration, or nerve involvement. Standard pain treatment often includes opioid medicines, but these medicines may cause side effects such as sedation, nausea, constipation, dizziness, tolerance, or dependence. In some patients, pain may also have a nerve-related or inflammatory component, where medicines such as pregabalin and naproxen sodium may provide additional benefit.
A total of 98 eligible adult patients with histopathology-confirmed oral cancer and a baseline Visual Analog Scale pain score of 4 or more were included. Patients were randomly assigned into two treatment groups. One group received oral tramadol 50 mg every 4 hours, with dose adjustment according to pain relief and tolerability. The other group received oral pregabalin 75 mg twice daily with naproxen sodium 550 mg twice daily. Both treatments were given for 7 days under clinical monitoring.
Pain intensity was measured using the Visual Analog Scale at baseline, day 3, and day 7. The main outcome was the mean reduction in pain score from baseline to day 7. Effective pain relief was defined as at least 50% reduction in the baseline pain score after 7 days of treatment. Side effects such as sedation, nausea or vomiting, constipation, dizziness, and gastrointestinal discomfort were also recorded. Patient satisfaction with pain control was assessed at the end of treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Tramadol | Active comparator | Drug: TramadolReceived oral tramadol 50 mg every 4 hours for pain management. Dose titration was done according to pain relief and tolerability. Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects. |
| Group B Pregabalin Plus Naproxen Sodium | Experimental | Drug: Pregabalin + Naproxen SodiumReceived oral pregabalin 75 mg twice daily along with oral naproxen sodium 550 mg twice daily for pain management. Treatment was continued for 7 days with clinical monitoring for pain response and adverse effects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older
- Histopathology confirmed diagnosis of oral cancer
- Experiencing moderate to severe pain (VAS ≥ 4)
- Either opioid-naïve or off opioids for at least one week
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Known allergy to morphine, pregabalin, or NSAIDs
- History of renal impairment, gastrointestinal bleeding, or peptic ulcer disease
- Concurrent use of other strong analgesics
- Psychiatric illness or cognitive impairment interfering with pain assessment
- Pregnancy or lactation
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 |
|---|---|---|
| TramadolOral tramadol 50 mg was administered every 4 hours for 7 days. Dose adjustment was made according to clinical response and tolerability. | Drug | Group A Tramadol |
| Pregabalin + Naproxen SodiumOral pregabalin 75 mg was administered twice daily for 7 days. Oral naproxen sodium 550 mg was administered twice daily for 7 days. | Drug | Group B Pregabalin Plus Naproxen Sodium |
Primary outcome
Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7
Time frame: Baseline and Day 7
Pain intensity was assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicated no pain and 10 indicated the worst imaginable pain. The mean change in pain score was calculated by subtracting the day 7 Visual Analog Scale score from the baseline Visual Analog Scale score. A greater positive change indicated greater reduction in pain intensity. The mean change was compared between the tramadol group and the pregabalin plus naproxen sodium group.
2 secondary outcomes
Effective Pain Relief at Day 7
Time frame: Baseline to Day 7
Severity of Adverse Events
Time frame: Day 0 to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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.
Rooshan Tahir Qazi principal investigator
Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tramadol and Pregabalin + Naproxen Sodium in people with Oral Cancer and Oral Cavity Cancer, run by Mayo Hospital Lahore at 1 site in Pakistan.
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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 26 May 2026. 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 Pakistan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7 (time frame: Baseline and Day 7). 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 26 May 2026.