Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
The goal of this clinical trial is to find out whether a phenotype-based pain management approach can reduce chronic pain in adults (18 years and older) who have completed curative treatment for head and neck cancer and continue to experience chronic post-treatment pain.
The main questions it aims to answer are:
- Does a phenotype-based pain management approach reduce participants' average pain by at least 75% after one month of treatment?
- Is the treatment safe, with 10% or fewer participants stopping treatment because of side effects?
Participants will:
- Attend three study visits over one month (at baseline, 2 weeks, and 4 weeks).
- Complete questionnaires about their pain, anxiety, depression, medication side effects, and use of pain medicines.
- Undergo a detailed examination to identify the type (phenotype) of their pain.
- Receive a treatment plan tailored to their pain phenotype, which may include medications, trigger point injections, or nerve blocks, depending on their symptoms and pain severity.
- Return for follow-up visits to assess pain relief, medication side effects, and use of breakthrough pain medication.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Khawaja S Nasir
- Phone Number: 4452 924235905000
- Email: shehryarnasir@skm.org.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Shaukat 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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults (≥18 years) with history of curative treatment for head and neck cancer
- Chronic post-treatment pain disorder
- Absence of clinical and radiological evidence of recurrent disease
- Ability to provide informed consent
Exclusion Criteria:
- Active disease recurrence or metastasis
- Persistent mucositis, oral infection, or hardware failure at the treatment site
- Surgical wound dehiscence
- Cognitive impairment that limits the ability to complete study questionnaires
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
Treatment given based on the clinical phenotype |
Participants with myofascial pain disorder will initially receive muscle relaxants, such as tizanidine (up to 8 mg per day), cyclobenzaprine (up to 30 mg per day), or amitriptyline (up to 25 mg per day). When the reported pain intensity is 7 or more out of 10, these participants will additionally undergo masticatory or cervical trigger point injections. Participants identified with orofacial bone pain disorder who report a pain intensity of less than 7 out of a possible 10 on the Numeric Verbal Rating Scale (NVRS) will receive non-opioid analgesics, including acetaminophen and non-steroidal anti-inflammatory medications. In cases where the pain intensity is 7 or more, participants will be offered targeted nerve blocks. These blocks will be performed along the sensory nerves supplying the affected region to provide localized pain relief. Participants classified with neuralgia will be treated with pregabalin (up to 600 mg per day) or carbamazepine (up to 1200 mg per day). Nerve blocks will be considered for those experiencing pain of 7 or more out of 10. In summary, participants with persistent pain disorder, burning disorder, or neuralgia phenotypes who present with pain intensity scores of 7 or higher will be given nerve blocks around the sensory nerves corresponding to the region of pain. Participants with burning pain will receive pregabalin (up to 600 mg per day), carbamazepine (up to 1200 mg per day), or clonazepam (up to 2 mg per day), and if their pain intensity meets or exceeds 7 out of 10, nerve blocks will similarly be provided to target the sensory pathways involved. Those diagnosed with persistent pain disorder will be treated with either amitriptyline (up to 25 mg per day) or pregabalin (up to 600 mg per day). Participants in this group who report pain intensity of 7 or more will also be offered nerve blocks administered at sites corresponding to the involved sensory distribution. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Reduction
Time Frame: From enrollment to the end of treatment at 4 weeks
|
A phenotype-based pain management model will provide significant pain relief to participants at one month, defined as at least a 75 percent decrease from average baseline pain |
From enrollment to the end of treatment at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Profile
Time Frame: From enrollment to the end of treatment at 4 weeks
|
Discontinuation of assigned phenotype-based therapy due to adverse events by four weeks is 10 percent or less. |
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- Nasir KS, Hafeez H, Jamshed A, Hussain RT. Effectiveness of Nerve Blocks for the Management of Head and Neck Cancer Associated Neuropathic Pain Disorders; a Retrospective Study. J Cancer Allied Spec. 2020 May 12;6(2):e367. doi: 10.37029/jcas.v6i2.367. eCollection 2020.
- Khawaja SN, Rehman SA, Mansoor M, Hafeez H. Chronic Post-Treatment Pain in Head and Neck Cancer Survivors: A Descriptive Analysis of Phenotypic Overlap. Oral Dis. 2026 Mar;32(3):832-839. doi: 10.1111/odi.70129. Epub 2025 Oct 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-26-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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