Head and Neck Cancer
Conditions
Keywords
Head and neck cancer, Radiotherapy-related pain, Calcitonin gene-related peptide
Brief summary
This prospective study investigates the dynamic changes in plasma calcitonin gene-related peptide (CGRP) levels during radiotherapy and their association with radiotherapy-related pain in patients with head and neck malignancies.
Detailed description
Radiotherapy-related pain is a major clinical challenge that significantly affects the long-term quality of life and treatment adherence of patients with head and neck cancer. Current analgesic strategies offer limited efficacy, and reliable biomarkers for predicting pain risk are lacking. In recent years, calcitonin gene-related peptide (CGRP) has drawn increasing attention for its critical role in chronic pain regulation, as demonstrated in various pain models. However, no systematic studies have yet investigated the expression patterns and clinical relevance of CGRP in radiotherapy-induced pain among patients with head and neck malignancies. This single-center, prospective observational study aims to enroll patients with head and neck cancer receiving either definitive or postoperative adjuvant radiotherapy. Plasma samples will be collected before, during, and after radiotherapy for measurement of CGRP levels. Pain intensity will be simultaneously assessed using the Numeric Rating Scale (NRS) and the Brief Pain Inventory-Short Form (BPI-SF). The study seeks to explore the dynamic changes in plasma CGRP levels throughout the radiotherapy course and to analyze their correlation with patient-reported pain, thereby providing potential insights into biomarker-based pain prediction and management strategies in this patient population.
Interventions
None listed
Sponsors
West China Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years Histologically confirmed head and neck malignancy Planned to receive definitive or postoperative adjuvant radiotherapy Radiotherapy duration ≥ 4 weeks, with irradiation field involving the oral cavity, pharynx, or neck region Able and willing to provide written informed consent Able to complete pain assessments and blood sample collection
Exclusion criteria
* History of significant chronic pain prior to radiotherapy (e.g., postherpetic neuralgia, rheumatoid arthritis) Presence of uncontrolled hypertension, diabetes, or migraines Presence of other active malignancies or major systemic diseases (e.g., severe hepatic or renal dysfunction) Currently receiving or recently received treatments that may significantly affect pain perception (e.g., opioids, antidepressants) Pregnant or breastfeeding Inability to complete follow-up or poor treatment compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in plasma CGRP level | Baseline (prior to the initiation of radiotherapy), At the end of the third week of radiotherapy (approximately 21±2 days after the 15th radiotherapy session), Within one week after the completion of radiotherapy. | To assess dynamic changes in CGRP levels during the course of radiotherapy. |
| Correlation between CGRP levels and pain scores (NRS and BPI-SF) | Baseline (prior to the initiation of radiotherapy), At the end of the third week of radiotherapy (approximately 21±2 days after the 15th radiotherapy session), Within one week after the completion of radiotherapy. | To evaluate the association between CGRP expression and radiotherapy-induced pain. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORXingchen Peng
Department of Biotherapy, West China Hospital, Sichuan University
Outcome results
None listed