Clinical trial · Observational
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels in Patients With Head and Neck Malignancies Undergoing Radiotherapy
A Prospective Clinical Study for Analyzing Plasma Calcitonin Gene-Related Peptide (CGRP) Levels in Patients With Head and Neck Malignancies Undergoing Radiotherapy
NCT07029373CI-TRIAL-00108900completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Change in plasma CGRP level
- timeFrame
- 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.
- description
- To assess dynamic changes in CGRP levels during the course of radiotherapy.
- measure
- Correlation between CGRP levels and pain scores (NRS and BPI-SF)
- timeFrame
- 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.
- description
- To evaluate the association between CGRP expression and radiotherapy-induced pain.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.