A Phase 2 interventional study of myofascial pain and Orofacial bone pain in Cancer Pain, Orofacial Pain and Head and Neck Cancer, sponsored by Shaukat Khanum Memorial Cancer Hospital & Research Centre. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Shaukat Khanum Memorial Cancer Hospital & Research Centre · Phase 2, Interventional, and Treatment
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:
Participants will:
345 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 259 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Shaukat Khanum Memorial Cancer Hospital & Research Centre is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Phenotype-based treatment of the HNC-related pain
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
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.
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.
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.
Those with neuralgia pain phenotype will receive pregabalin (up to 600 mg a day) or carbamazepine (up to 600 mg a day).
The participants with burning disorder phenotype will receive pregabalin (up to 600 mg a day) or clonazepam (up to 2 mg a day).
The participants with persistent pain disorder phenotype will receive amitriptyline (up to 25 mg a day) or pregabalin (up to 600 mg a day).
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.
Time frame: From enrollment to the end of treatment at 7 days.
Safety of the treatment plan
Discontinuation of assigned phenotype-based therapy due to adverse events by 7 days is 10 percent or less.
Time frame: From enrollment to the end of treatment at 7 days.
Plan to share: 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.
Supporting information: Statistical analysis plan
Time frame: Approximately data will be available from 1 March 2027 (at the time of publication) till 5 years after the publication of the article (1 March 2031).
Access criteria: Researchers with methodologically sound proposals aimed to advance the field of pain medicine.
Started Feb 2025 (actual). Primary completion is estimated for Jan 2027, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Shaukat Khanum Memorial Cancer Hospital & Research Centre