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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Khawaja S Nasir
- Numéro de téléphone: 4452 924235905000
- E-mail: shehryarnasir@skm.org.pk
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Recrutement
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
-
Contact:
- Khawaja S Nasir
- Numéro de téléphone: 4452 924235905000
- E-mail: shehryarnasir@skm.org.pk
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain Reduction
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety Profile
Délai: 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
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-26-02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
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).
Critères d'accès au partage IPD
Researchers with methodologically sound proposals aimed to advance the field of pain medicine.
Type d'informations de prise en charge du partage d'IPD
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
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