Plasma Calcitonin Gene-Related Peptide (CGRP) Levels in Patients With Head and Neck Malignancies Undergoing Radiotherapy

NCT07029373 | Completed

• 1 other identifier: 2025-989
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and neck cancer; Radiotherapy-related pain; Calcitonin gene-related peptide

Outcome Measures

Primary Outcomes (2)

• Change in plasma CGRP level

  To assess dynamic changes in CGRP levels during the course of radiotherapy.

  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.

• Correlation between CGRP levels and pain scores (NRS and BPI-SF)

  To evaluate the association between CGRP expression and radiotherapy-induced pain.

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with histologically confirmed head and neck malignancies scheduled to receive definitive or postoperative adjuvant radiotherapy (≥4 weeks) involving the oral cavity, pharynx, or neck will be enrolled. Exclusion criteria include pre-existing significant chronic pain (e.g., postherpetic neuralgia, rheumatoid arthritis), uncontrolled hypertension, diabetes, or migraines, other active malignancies or major systemic diseases (e.g., severe hepatic/renal dysfunction), recent or current use of medications affecting pain perception (e.g., opioids, antidepressants), pregnancy or breastfeeding, and inability to complete follow-up or poor treatment compliance.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Prospective observational study

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Xingchen Peng

  Department of Biotherapy, West China Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 19, 2025
• Study Start: July 4, 2025
• Primary Completion: April 2, 2026
• Study Completion: April 2, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CN (1)