Head and Neck CancerNCT07029373
Plasma Calcitonin Gene-Related Peptide (CGRP) Levels in Patients With Head and Neck Malignancies Undergoing Radiotherapy
An observational study of Head and Neck Cancer, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2025to 2 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Clinical Study for Analyzing Plasma Calcitonin Gene-Related Peptide (CGRP) Levels in Patients With Head and Neck Malignancies Undergoing Radiotherapy
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, Radiotherapy-related pain, Calcitonin gene-related peptide
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma CGRP level
To assess dynamic changes in CGRP levels during the course of radiotherapy.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start4 Jul 2025
- Primary completion2 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
- Investigators
- Xingchen Peng, Principal investigator, Department of Biotherapy, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029373
- Sponsor's protocol ID
- 2025-989
- Status last verified
- Apr 2026
- First submitted
- 1 Jun 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study for Analyzing Plasma Calcitonin Gene-Related Peptide (CGRP) Levels in Patients With Head and Neck Malignancies Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT07029373
- Acronym / sponsor ID
- 2025-989
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck cancer, Radiotherapy-related pain, Calcitonin gene-related peptide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 4 Jul 2025 (actual)
- Primary completion
- 2 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Related trials for Head and Neck Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingchen Peng principal investigator
Department of Biotherapy, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.