Investigating long-term vascular complications after radiation in head and neck cancer patients

The Ambidirectional Cohort Study of Neurovascular Complications After Radiation Therapy in Head and Neck Cancer Patients

This study looks at how radiation treatment affects blood vessel health over time in people with head and neck cancer, comparing those with nasopharyngeal cancer to others.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 20 Years to 100 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Taipei)
• Trial ID: NCT06111430 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the prevalence of cervical-cranial vascular complications in patients with head and neck cancer who have received radiation therapy. It will compare outcomes between patients with nasopharyngeal cancer and those with other types of head and neck cancers. Participants will be recruited based on their history of radiation treatment and will undergo brain imaging and vascular studies to evaluate complications. The study focuses on both early and long-term effects of radiation therapy on vascular health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 and older who have been diagnosed with head and neck cancer and have received radiation therapy within the last 72 months or more than 120 months ago.

Not a fit: Patients under 20 years of age or those unwilling to provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of long-term vascular risks in head and neck cancer patients, leading to better monitoring and management strategies.

How similar studies have performed: While there is ongoing research into the effects of radiation therapy on vascular health, this specific focus on long-term complications in head and neck cancer patients is relatively novel.

Eligibility criteria

Population: Prospective cohort

Inclusion Criteria:

1. Age ≥20 years.
2. Head and neck cancer patient .
3. Had ever received radiation therapy (RT) ≦ 72 months before inclusion in the registry.
4. Had ≥ 1 brain images and cervical-cranial vascular studies between the end of RT and d date of enrolment.

Exclusion Criteria:

1. Age \<20 years.
2. Patients not willing to sign the informed consent.

Population: Retrospective validation cohort

Inclusion Criteria:

1. Age ≥20 years.
2. Head and neck cancer patient.
3. Had ever received radiation therapy (RT) \> 120 months before the adoption date of IRB at the participant site.
4. Had ≥ 2 brain images and cervical-cranial vascular studies between the end of RT and 6\~10 years after RT, one within 5 years after RT, the other after 5 years after RT.

Exclusion Criteria:

1.Age \<20 years.

Where this trial is running

Taipei

• Chang Gung Memorial Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Chi-Hung Liu

Conditions Radiation Treatment; Neurovascular Complications