Current partner codePEPTIDESDE
NCT07029373·Not applicable·OBSERVATIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

23

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

No intervention details reported.

Timeline

From registration to results.

  1. First posted

    Jun 19, 2025

  2. Study start

    Jul 4, 2025

  3. Primary completion

    Apr 2, 2026

  4. Study completion

    Apr 2, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 21, 2026

Outcomes

What the study measures.

Primary outcomes

Change in plasma CGRP level

Time frame · 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)

Time frame · 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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Calcitonin.

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Put the record in context.

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