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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Khawaja S Nasir
- 전화번호: 4452 924235905000
- 이메일: shehryarnasir@skm.org.pk
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 54000
- 모병
- Shukat Khanum Memorial Cancer Hospital & Research Centre
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연락하다:
- Khawaja S Nasir
- 전화번호: 4452 924235905000
- 이메일: shehryarnasir@skm.org.pk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain relief
기간: From enrollment to the end of treatment at 7 days.
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety of the treatment plan
기간: From enrollment to the end of treatment at 7 days.
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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.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-24-30-A1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
Researchers with methodologically sound proposals aimed to advance the field of pain medicine.
IPD 공유 지원 정보 유형
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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