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.
Aperçu de l'étude
Statut
Les conditions
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
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Lahore, Punjab Province, Pakistan, 54000
- Recrutement
- Shukat 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:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Treatment Group
Phenotype-based treatment of the HNC-related 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. 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). |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain relief
Délai: From enrollment to the end of treatment at 7 days.
|
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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety of the treatment plan
Délai: From enrollment to the end of treatment at 7 days.
|
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.
|
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- 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.
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
- La douleur
- Manifestations neurologiques
- Maladies de la bouche
- Maladies stomatognathiques
- Maladies du système nerveux
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Carcinome
- Maladies des nerfs crâniens
- Carcinome épidermoïde
- Maladies du nerf trijumeau
- Névralgie faciale
- Maladies du nerf facial
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Carcinome épidermoïde de la tête et du cou
- Douleur cancéreuse
- Tumeurs de la tête et du cou
- La névralgie du trijumeau
- Douleur faciale
Autres numéros d'identification d'étude
- IRB-24-30-A1
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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