RECRUITING

QUantitative Assessment of Swallowing After Radiation (QUASAR)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To use novel methods for quantitative analysis of VFSS (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. immunotherapy (pembrolizumab, nivolumab, or durvalumab). Our hypothesis is that pharyngeal constriction will be greater (lower ratio) with concurrent immunotherapy compared to chemotherapy, as measured by the pharyngeal constriction ratio (PCR).

Official Title

QUantitative Assessment of Swallowing After Radiation (QUASAR): A Longitudinal Comparison of Swallowing Function by Systemic Therapy in Head and Neck Cancer Patients

Quick Facts

Study Start:2020-09-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04359199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy-proven, un-resected invasive carcinoma of the head and neck.
  2. * Treated with definitive RT and concurrent systemic therapy or treated within the past 4-24 months
  3. * Concurrent systemic therapy with Cisplatin, Cetuximab or immunotherapy.
  4. * Age ≥ 18
  5. * Able to understand and willing to sign a written informed consent.
  1. * Prior radiotherapy that would result in overlap of planned radiation therapy fields.
  2. * Prior systemic chemotherapy, unless as part of the coordinated plan of care for the treatment of the carcinoma (e.g., induction/neoadjuvant chemotherapy is allowed)
  3. * Planned adjuvant (i.e., following definitive chemoradiotherapy) chemotherapy or surgery

Contacts and Locations

Study Contact

Khusbu Singh, MBBS, CCRP
CONTACT
858-245-2604
ksingh@health.ucsd.edu
Gerald Henderson
CONTACT
858-534-4811
gehenderson@health.ucsd.edu

Principal Investigator

Loren K Mell, MD
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

UC San Diego Moores Cancer Center
La Jolla, California, 92093
United States
UCSD Moores Cancer Center
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: Loren Mell, MD

  • Loren K Mell, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2020-09-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • head and neck cancer
  • oropharyngeal dysphagia
  • radiation therapy
  • immunotherapy
  • videofluoroscopic swallow study
  • modified barium swallow study
  • oropharynx cancer
  • oropharynx squamous cell carcinoma

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Dysphagia
  • Oropharyngeal Dysphagia
  • Oropharynx Cancer
  • Oropharynx Squamous Cell Carcinoma