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RecruitingNCT07919457Updated Nov 5, 2026

Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study

A Phase 2 interventional study of Myofascial Pain and Orofacial Bone Pain in Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain and Chronic Post Operative Pain, 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

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2026, registered Nov 2026).
  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Chronic Postsurgical Pain
  • Chronic Post Cancer Surgery Pain
  • Chronic Post Operative Pain
  • Radiation Effects
  • Chemotherapy Induced Pain

Keywords

  • Chronic post-treatment pain
  • Head and neck cancers
  • Orofacial Pain
  • Trigeminal
  • Radiation therapy
  • Phenotype
03

In context

Pain, Postoperative

5,265 studies on the registry are indexed under Pain, Postoperative; 1,165 are open to participants now.

This study's planned enrollment of 40 is below the median of 75 across 4,496 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre is the lead sponsor of 25 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Treatment given based on the clinical phenotype

    Other: Myofascial Pain · Other: Orofacial Bone Pain · Other: Neuralgia Pain · Other: Burning Pain · Other: Persistent Pain

Interventions

  • OtherMyofascial Pain

    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.

  • OtherOrofacial Bone Pain

    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.

  • OtherNeuralgia Pain

    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.

  • OtherBurning 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.

  • OtherPersistent Pain

    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.

06

What researchers measure

Primary outcomes

  1. Pain Reduction

    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

    Time frame: From enrollment to the end of treatment at 4 weeks

Secondary outcomes

  1. Safety Profile

    Discontinuation of assigned phenotype-based therapy due to adverse events by four weeks is 10 percent or less.

    Time frame: From enrollment to the end of treatment at 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 27475511 ↗
  • 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. PubMed 37197605 ↗
  • 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. PubMed 36404073 ↗
  • 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. PubMed 36404071 ↗
  • 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. PubMed 36404084 ↗
  • 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. PubMed 36404080 ↗
  • 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. PubMed 41133463 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

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.

Data sharing details ↗ · na

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.

Of 89 non-industry phase 2 interventional studies under Pain, Postoperative, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 33. This study's planned 6 months is below that.

Counting every sponsor, half of 137 studies reached it within 11 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 5, 2026
StartActual
Jul 16, 2026
Primary completionEst.
Jan 31, 2027
CompletionEst.
Feb 28, 2027
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07919457
Lead sponsor
Shaukat Khanum Memorial Cancer Hospital & Research Centre
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Jul 16, 2026
Primary completion
Jan 31, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Khawaja S Nasir
Contact
shehryarnasir@skm.org.pk
924235905000 ext. 4452

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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