CompletedNot Applicable

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

China23 participantsStarted 2025-07-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

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

Trial details

NCT IDNCT07029373

SponsorWest China Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-02

View on ClinicalTrials.gov More Head and Neck Cancer trials