Oral Cancer, Oral Cavity Cancer, Oral Squamous Cell Carcinoma (OSCC)
Conditions
Keywords
Oral cancer pain, Cancer pain management, Oral cavity neoplasms, Mouth neoplasms, Oral squamous cell carcinoma
Brief 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. 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.
Interventions
DRUGPregabalin + Naproxen Sodium
Oral pregabalin 75 mg was administered twice daily for 7 days. Oral naproxen sodium 550 mg was administered twice daily for 7 days.
DRUGTramadol
Oral tramadol 50 mg was administered every 4 hours for 7 days. Dose adjustment was made according to clinical response and tolerability.
Sponsors
Mayo Hospital Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Visual Analog Scale Pain Score From Baseline to Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective Pain Relief at Day 7 | Baseline to 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. |
| Severity of Adverse Events | Day 0 to Day 7 | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORRooshan Tahir Qazi
Mayo Hospital Lahore
Outcome results
None listed