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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Khawaja S Nasir
- Numero di telefono: 4452 924235905000
- Email: shehryarnasir@skm.org.pk
Luoghi di studio
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Reclutamento
- Shukat Khanum Memorial Cancer Hospital & Research Centre
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Contatto:
- Khawaja S Nasir
- Numero di telefono: 4452 924235905000
- Email: shehryarnasir@skm.org.pk
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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). |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain relief
Lasso di tempo: 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.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Safety of the treatment plan
Lasso di tempo: 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.
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie della bocca
- Malattie stomatognatiche
- Malattie del sistema nervoso
- Neoplasie per sede
- Neoplasie
- Neoplasie per tipo istologico
- Neoplasie, ghiandolari ed epiteliali
- Carcinoma
- Malattie dei nervi cranici
- Carcinoma, cellule squamose
- Malattie del nervo trigemino
- Nevralgia facciale
- Malattie del nervo facciale
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Carcinoma a cellule squamose della testa e del collo
- Dolore Cancro
- Neoplasie della testa e del collo
- Nevralgia del trigemino
- Dolore facciale
Altri numeri di identificazione dello studio
- IRB-24-30-A1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione 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).
Criteri di accesso alla condivisione IPD
Researchers with methodologically sound proposals aimed to advance the field of pain medicine.
Tipo di informazioni di supporto alla condivisione IPD
- LINFA
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