Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot 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:

• 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 Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Cancer Pain; Orofacial Pain; Head and Neck (HNSCC)
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Khawaja S Nasir; Phone Number: 4452 924235905000; Email: shehryarnasir@skm.org.pk

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Recruiting
      • Shukat Khanum Memorial Cancer Hospital & Research Centre
      • Contact: Khawaja S Nasir; Phone Number: 4452 924235905000; Email: shehryarnasir@skm.org.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participants on active or history of prior oncological treatment (radiation therapy, chemotherapy, or immune check point inhibitors) will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Group; Phenotype-based treatment of the HNC-related pain

Combination product: myofascial pain; 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.; Combination product: Orofacial bone pain; 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.; Combination product: Orofacial Mucosal Pain; 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.; Combination product: Neuralgia Pain; Those with neuralgia pain phenotype will receive pregabalin (up to 600 mg a day) or carbamazepine (up to 600 mg a day).; Combination product: Burning Pain; The participants with burning disorder phenotype will receive pregabalin (up to 600 mg a day) or clonazepam (up to 2 mg a day).; Combination product: Persistent Pain Phenotype; The participants with persistent pain disorder phenotype will receive amitriptyline (up to 25 mg a day) or pregabalin (up to 600 mg a day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of treatment at 7 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the treatment plan	Discontinuation of assigned phenotype-based therapy due to adverse events by 7 days is 10 percent or less.	From enrollment to the end of treatment at 7 days.

Collaborators and Investigators

• Sponsor: Shaukat Khanum Memorial Cancer Hospital & Research Centre

Publications and helpful links

General 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.
• Khawaja 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.
• Khawaja 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.
• Hernandez-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.
• Bajwa 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.
• Khawaja 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: November 1, 2026
• First Submitted That Met QC Criteria: November 1, 2026
• First Posted (Actual): November 5, 2026

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 1, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Cancer pain; Phenotype; orofacial pain; head and neck cancers; trigeminal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Cranial Nerve Diseases; Carcinoma, Squamous Cell; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Squamous Cell Carcinoma of Head and Neck; Cancer Pain; Head and Neck Neoplasms; Trigeminal Neuralgia; Facial Pain
• Other Study ID Numbers: IRB-24-30-A1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing 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).

IPD Sharing Access Criteria

Researchers with methodologically sound proposals aimed to advance the field of pain medicine.

• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No