Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

1. november 2026 opdateret af: Shaukat Khanum Memorial Cancer Hospital & Research Centre

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Rekruttering
        • Shaukat Khanum Memorial Cancer Hospital & Research Centre
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment Group

Treatment given based on the clinical phenotype
Andet: Myofascial 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.

Andet: Orofacial 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.

Andet: Neuralgia 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.

Andet: Burning 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.

Andet: Persistent 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Reduction
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety Profile
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. juli 2026

Primær færdiggørelse (Anslået)

31. januar 2027

Studieafslutning (Anslået)

28. februar 2027

Datoer for studieregistrering

Først indsendt

1. november 2026

Først indsendt, der opfyldte QC-kriterier

1. november 2026

Først opslået (Faktiske)

5. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-26-02

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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-delingsadgangskriterier

Researchers with methodologically sound proposals aimed to advance the field of pain medicine.

IPD-deling Understøttende informationstype

  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner