Cancer PainPhase 2NCT07919444
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
A Phase 2 study testing myofascial pain, Orofacial bone pain and Orofacial Mucosal Pain in people with Cancer Pain and Orofacial Pain, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to find out whether phenotype-based pain management guidelines can effectively and safely reduce head and neck cancer-related pain in adults with head and neck cancer who have not yet started cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Orofacial Pain, Head and Neck Cancer
- What is being tested?
- myofascial pain, Orofacial bone pain and Orofacial Mucosal Pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Feb 2025to 31 Jan 2027
- Phase
- Phase 2
- 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
- All adult male and female patients with HNC-related pain that have at least 5 or more intensity average pain intensity in the last one week on a 11-point numeric verbal pain rating scale (NVRS), where 0 is indicative of "no pain" and 10 is suggestive of "worst pain imaginable."
- Participants with a diagnosis of head and neck cancer-related pain.
Who cannot join
- Participants on active or history of prior oncological treatment (radiation therapy, chemotherapy, or immune check point inhibitors) will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shukat Khanum Memorial Cancer Hospital & Research Centre
Lahore, Punjab Province, 54000
Khawaja S Nasir, 924235905000 ext. 4452, shehryarnasir@skm.org.pk
About this study
The goal of this clinical trial is to find out whether phenotype-based pain management guidelines can effectively and safely reduce head and neck cancer-related pain in adults with head and neck cancer who have not yet started cancer treatment.
The main questions it aims to answer are:
Read more
- Do phenotype-based pain management guidelines reduce pain in people with head and neck cancer within the first week of treatment?
- Are the guidelines safe, based on the number and type of medication-related side effects experienced by participants?
Participants will:
- Attend three study visits over approximately one week (at baseline, after 3 days, and after 7 days or before starting cancer treatment, whichever comes first).
- Complete questionnaires about their pain, anxiety, depression, medication side effects, and use of breakthrough pain medication.
- Undergo a detailed examination to identify the type (phenotype) of their pain.
- Receive a treatment plan tailored to their pain phenotype, which may include pain-relieving medications, muscle relaxants, medicines for nerve pain or burning pain, and opioid medications when needed based on pain severity.
- Return for follow-up visits to assess changes in pain, medication side effects, and use of breakthrough pain medication.
- Being tested
- myofascial pain, Orofacial bone pain, Orofacial Mucosal Pain, Neuralgia Pain, Burning Pain
- Keywords
- Cancer pain, orofacial pain, head and neck cancers, trigeminal pain, Phenotype
- Medical subject headings
- Cancer Pain, Facial Pain, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myofascial painCombination product
Participants with myofascial pain disorder phenotype will receive a muscle relaxant, such as tizanidine (up to 8 mg a day), cyclobenzaprine (up to 30 mg a day) or amitriptyline (up to 25 mg a day). In addition, depending on the pain intensity, they will receive non-opioid analgesics or opioids. The participants with pain intensity of less than 7 out of possible 10, on a NVRS, will receive non-opioid analgesics (acetaminophen and non-steroidal anti-inflammatory medications). However, if the intensity of pain is higher (7 or more), they will receive non-opioid analgesics and opioids (codeine, tramadol or morphine). For pain with intensity between 7 and 8 out of possible 10, on a NRVS, tramadol (up to 400 mg a day) or codeine (up to 90 mg a day) will be used. However, if the intensity of pain is 9 or more of 10, morphine (up to 60 mg a day) will be used.
Orofacial bone painCombination product
The participants with a phenotype of orofacial bone pain and a pain intensity of less than 7 out of a possible 10 on an NVRS will receive non-opioid analgesics (acetaminophen and non-steroidal anti-inflammatory medications). However, if the intensity of pain is higher (7 or more), they will receive non-opioid analgesics and opioids (codeine, tramadol or morphine). For pain with an intensity between 7 and 8 out of a possible 10 on an NRVS, tramadol (up to 400 mg a day) or codeine (up to 90 mg a day) will be used. However, if the intensity of pain is 9 or more of 10, morphine (up to 60 mg a day) will be used.
Orofacial Mucosal PainCombination product
The participants with a phenotype of orofacial mucosal pain and a pain intensity of less than 7 out of a possible 10 on an NVRS will receive non-opioid analgesics (acetaminophen and non-steroidal anti-inflammatory medications). However, if the intensity of pain is higher (7 or more), they will receive non-opioid analgesics and opioids (codeine, tramadol, or morphine). For pain with intensity between 7 and 8 out of possible 10, on an NRVS, tramadol (up to 400 mg a day) or codeine (up to 90 mg a day) will be used. However, if the intensity of pain is 9 or more of 10, morphine (up to 60 mg a day) will be used.
Neuralgia PainCombination product
Those with neuralgia pain phenotype will receive pregabalin (up to 600 mg a day) or carbamazepine (up to 600 mg a day).
Burning PainCombination product
The participants with burning disorder phenotype will receive pregabalin (up to 600 mg a day) or clonazepam (up to 2 mg a day).
Persistent Pain PhenotypeCombination product
The participants with persistent pain disorder phenotype will receive amitriptyline (up to 25 mg a day) or pregabalin (up to 600 mg a day).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Phenotype-based treatment of the HNC-related pain Receives: Combination Product: myofascial pain; Combination Product: Orofacial bone pain; Combination Product: Orofacial Mucosal Pain; Combination Product: Neuralgia Pain; Combination Product: Burning Pain; Combination Product: Persistent Pain Phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
A phenotype-based pain management model will provide significant pain relief to participants at 7 days, defined as at least a 75 percent decrease from average baseline pain.
Measured: From enrollment to the end of treatment at 7 days.
Secondary outcomes (1)
Safety of the treatment plan
Discontinuation of assigned phenotype-based therapy due to adverse events by 7 days is 10 percent or less.
Measured: From enrollment to the end of treatment at 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start26 Feb 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- During the course of the investigation, participants will undergo three assessments. The participants will undergo a detailed history and clinical examination. Based on this they will be assigned clinical phenotypes of HNC-related pain (Myofascial pain disorder, Orofacial bone pain disorder, Oral mucosal pain, Burning pain disorder, Neuralgia, Persistent pain disorder and Unknown), and recieve clinical-guidelines based management. In the second and third visits, they will be asked about the pain (intensity, location, duration, quality, and frequency), medication-related side effects, episodes of breakthrough pain and use of abortive analgesics.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919444
- Sponsor's protocol ID
- IRB-24-30-A1
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with the journal at the time of publication. To ensure the confidentiality of subject information, each subject enrolled will be assigned a unique serial number.
Publications
Khawaja S, Bavarian R, Abdul Rehman S, Hafeez H. Head and Neck Cancer-Related Pain: A Descriptive Analysis of the Pain Phenotypes. J Pain Res. 2023 Aug 25;16:2919-2927. doi: 10.2147/JPR.S411285. eCollection 2023.
PubMed 37649626Khawaja SN, Alaswaiti OF, Scrivani SJ. Burning Mouth Syndrome. Dent Clin North Am. 2023 Jan;67(1):49-60. doi: 10.1016/j.cden.2022.07.004. Epub 2022 Oct 27.
PubMed 36404080Khawaja SN, Scrivani SJ. Trigeminal Neuralgia. Dent Clin North Am. 2023 Jan;67(1):99-115. doi: 10.1016/j.cden.2022.07.008. Epub 2022 Oct 27.
PubMed 36404084Hernandez-Nuno de la Rosa MF, Guerrero P, Alturki SA, Scrivani SJ. Masticatory Myofascial Pain Disorders. Dent Clin North Am. 2023 Jan;67(1):1-11. doi: 10.1016/j.cden.2022.07.001. Epub 2022 Oct 27.
PubMed 36404071Bajwa ZH, Smith SS, Khawaja SN, Scrivani SJ. Cranial Neuralgias. Oral Maxillofac Surg Clin North Am. 2016 Aug;28(3):351-70. doi: 10.1016/j.coms.2016.04.001.
PubMed 27475511Khawaja SN, Scrivani SJ. Head and Neck Cancer-Related Pain. Dent Clin North Am. 2023 Jan;67(1):129-140. doi: 10.1016/j.cden.2022.07.010. Epub 2022 Oct 27.
PubMed 36404073
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
- ClinicalTrials.gov ID
- NCT07919444
- Acronym / sponsor ID
- IRB-24-30-A1
- Keywords
- Cancer pain, orofacial pain, head and neck cancers, trigeminal pain, Phenotype
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Nov 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.
The goal of this clinical trial is to find out whether phenotype-based pain management guidelines can effectively and safely reduce head and neck cancer-related pain in adults with head and neck cancer who have not yet started cancer treatment.
The main questions it aims to answer are:
- Do phenotype-based pain management guidelines reduce pain in people with head and neck cancer within the first week of treatment?
- Are the guidelines safe, based on the number and type of medication-related side effects experienced by participants?
Participants will:
- Attend three study visits over approximately one week (at baseline, after 3 days, and after 7 days or before starting cancer treatment, whichever comes first).
- Complete questionnaires about their pain, anxiety, depression, medication side effects, and use of breakthrough pain medication.
- Undergo a detailed examination to identify the type (phenotype) of their pain.
- Receive a treatment plan tailored to their pain phenotype, which may include pain-relieving medications, muscle relaxants, medicines for nerve pain or burning pain, and opioid medications when needed based on pain severity.
- Return for follow-up visits to assess changes in pain, medication side effects, and use of breakthrough pain medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During the course of the investigation, participants will undergo three assessments. The participants will undergo a detailed history and clinical examination. Based on this they will be assigned clinical phenotypes of HNC-related pain (Myofascial pain disorder, Orofacial bone pain disorder, Oral mucosal pain, Burning pain disorder, Neuralgia, Persistent pain disorder and Unknown), and recieve clinical-guidelines based management. In the second and third visits, they will be asked about the pain (intensity, location, duration, quality, and frequency), medication-related side effects, episodes of breakthrough pain and use of abortive analgesics.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Combination Product: myofascial pain, Combination Product: Orofacial bone pain, Combination Product: Orofacial Mucosal Pain, Combination Product: Neuralgia Pain, Combination Product: Burning Pain, Combination Product: Persistent Pain PhenotypePhenotype-based treatment of the HNC-related pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult male and female patients with HNC-related pain that have at least 5 or more intensity average pain intensity in the last one week on a 11-point numeric verbal pain rating scale (NVRS), where 0 is indicative of "no pain" and 10 is suggestive of "worst pain imaginable."
- Participants with a diagnosis of head and neck cancer-related pain.
Key exclusion criteria (1 listed)
- Participants on active or history of prior oncological treatment (radiation therapy, chemotherapy, or immune check point inhibitors) will be excluded.
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 |
|---|---|---|
| myofascial painParticipants with myofascial pain disorder phenotype will receive a muscle relaxant, such as tizanidine (up to 8 mg a day), cyclobenzaprine (up to 30 mg a day) or amitriptyline (up to 25 mg a day). In addition, depending on the pain intensity, they will receive non-opioid analgesics or opioids. The participants with pain intensity of less than 7 out of possible 10, on a NVRS, will receive non-opioid analgesics (acetaminophen and non-steroidal anti-inflammatory medications). However, if the intensity of pain is higher (7 or more), they will receive non-opioid analgesics and opioids (codeine, tramadol or morphine). For pain with intensity between 7 and 8 out of possible 10, on a NRVS, tramadol (up to 400 mg a day) or codeine (up to 90 mg a day) will be used. However, if the intensity of pain is 9 or more of 10, morphine (up to 60 mg a day) will be used. | Combination product | Treatment Group |
| Orofacial bone painThe participants with a phenotype of orofacial bone pain and a pain intensity of less than 7 out of a possible 10 on an NVRS will receive non-opioid analgesics (acetaminophen and non-steroidal anti-inflammatory medications). However, if the intensity of pain is higher (7 or more), they will receive non-opioid analgesics and opioids (codeine, tramadol or morphine). For pain with an intensity between 7 and 8 out of a possible 10 on an NRVS, tramadol (up to 400 mg a day) or codeine (up to 90 mg a day) will be used. However, if the intensity of pain is 9 or more of 10, morphine (up to 60 mg a day) will be used. | Combination product | Treatment Group |
| Orofacial Mucosal PainThe participants with a phenotype of orofacial mucosal pain and a pain intensity of less than 7 out of a possible 10 on an NVRS will receive non-opioid analgesics (acetaminophen and non-steroidal anti-inflammatory medications). However, if the intensity of pain is higher (7 or more), they will receive non-opioid analgesics and opioids (codeine, tramadol, or morphine). For pain with intensity between 7 and 8 out of possible 10, on an NRVS, tramadol (up to 400 mg a day) or codeine (up to 90 mg a day) will be used. However, if the intensity of pain is 9 or more of 10, morphine (up to 60 mg a day) will be used. | Combination product | Treatment Group |
| Neuralgia PainThose with neuralgia pain phenotype will receive pregabalin (up to 600 mg a day) or carbamazepine (up to 600 mg a day). | Combination product | Treatment Group |
| Burning PainThe participants with burning disorder phenotype will receive pregabalin (up to 600 mg a day) or clonazepam (up to 2 mg a day). | Combination product | Treatment Group |
| Persistent Pain PhenotypeThe participants with persistent pain disorder phenotype will receive amitriptyline (up to 25 mg a day) or pregabalin (up to 600 mg a day). | Combination product | Treatment Group |
Primary outcome
Pain relief
Time frame: From enrollment to the end of treatment at 7 days.
A phenotype-based pain management model will provide significant pain relief to participants at 7 days, defined as at least a 75 percent decrease from average baseline pain.
1 secondary outcome
Safety of the treatment plan
Time frame: From enrollment to the end of treatment at 7 days.
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 5 Nov 2026.
- Background: PubMed 37649626Khawaja S, Bavarian R, Abdul Rehman S, Hafeez H. Head and Neck Cancer-Related Pain: A Descriptive Analysis of the Pain Phenotypes. J Pain Res. 2023 Aug 25;16:2919-2927. doi: 10.2147/JPR.S411285. eCollection 2023.
- Background: PubMed 36404080Khawaja SN, Alaswaiti OF, Scrivani SJ. Burning Mouth Syndrome. Dent Clin North Am. 2023 Jan;67(1):49-60. doi: 10.1016/j.cden.2022.07.004. Epub 2022 Oct 27.
- Background: PubMed 36404084Khawaja SN, Scrivani SJ. Trigeminal Neuralgia. Dent Clin North Am. 2023 Jan;67(1):99-115. doi: 10.1016/j.cden.2022.07.008. Epub 2022 Oct 27.
- Background: PubMed 36404071Hernandez-Nuno de la Rosa MF, Guerrero P, Alturki SA, Scrivani SJ. Masticatory Myofascial Pain Disorders. Dent Clin North Am. 2023 Jan;67(1):1-11. doi: 10.1016/j.cden.2022.07.001. Epub 2022 Oct 27.
- Background: PubMed 27475511Bajwa ZH, Smith SS, Khawaja SN, Scrivani SJ. Cranial Neuralgias. Oral Maxillofac Surg Clin North Am. 2016 Aug;28(3):351-70. doi: 10.1016/j.coms.2016.04.001.
- Background: PubMed 36404073Khawaja SN, Scrivani SJ. Head and Neck Cancer-Related Pain. Dent Clin North Am. 2023 Jan;67(1):129-140. doi: 10.1016/j.cden.2022.07.010. Epub 2022 Oct 27.
- Individual participant dataSharing planned: Yes. IPD will be shared with the journal at the time of publication. To ensure the confidentiality of subject information, each subject enrolled will be assigned a unique serial number.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing myofascial pain, Orofacial bone pain and Orofacial Mucosal Pain in people with Cancer Pain and Orofacial Pain, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Nov 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Khawaja S Nasir (924235905000 ext. 4452, shehryarnasir@skm.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: From enrollment to the end of treatment at 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07919444, which also lists 6 linked publications.
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 5 Nov 2026.