Recruiting

Observational Study

Sponsor:

Loren Mell, MD

Code:

NCT04359199

Conditions

Head and Neck Cancer

Dysphagia

Oropharyngeal Dysphagia

Oropharynx Cancer

Oropharynx Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Therapy

Cetuximab

Chemotherapy

Immunotherapy

Study Details

Brief summary:

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).

Conditions

Head and Neck Cancer

Dysphagia

Oropharyngeal Dysphagia

Oropharynx Cancer

Oropharynx Squamous Cell Carcinoma

Study ID

NCT04359199

Start date

Sep 1, 2020

Status verified date

Feb, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Biopsy-proven, un-resected invasive carcinoma of the head and neck.
  • Treated with definitive RT and concurrent systemic therapy or treated within the past 4-24 months
  • Concurrent systemic therapy with Cisplatin, Cetuximab or immunotherapy.
  • Age ≥ 18
  • Able to understand and willing to sign a written informed consent.

Exclusion Criteria:

  • Prior radiotherapy that would result in overlap of planned radiation therapy fields.
  • 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)
  • Planned adjuvant (i.e., following definitive chemoradiotherapy) chemotherapy or surgery

Study Design

Enrollment

42 participants

Anticipated

Interventions and Outcome Measures

Arms

Radiotherapy with chemotherapy

Patients treated with definitive RT and chemotherapy (cisplatin) or targeted therapy (cetuximab)

Radiotherapy with immunotherapy

Patients treated with definitive RT and immunotherapy (pembrolizumab, nivolumab, or durvalumab)

Interventions

Radiation Therapy

Routine radiation dosing (approximately 70 Gy in 35 fractions over 6.5 weeks) to the head and neck for the treatment of head and neck cancer

Cetuximab

Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of head and neck cancer

Chemotherapy

Cisplatin is a chemotherapy medication used to treat a number of cancers, including head and neck cancer

Immunotherapy

Keytruda or Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface.

Opdivo or Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1) blocking antibody.

Imfinzi or Durvalumab is an anti-cancer ("antineoplastic") drug. This medication is classified as an Anti-PD-L1 monoclonal antibody.

Primary outcome measure

  • Swallowing function 12-24 months after concurrent radiation and systemic therapy for HNC, as measured by the PCR [ Time Frame: 12-24 months ]

Central Contacts and Locations

Central contacts

Khusbu Singh, MBBS, CCRP

858-245-2604ksingh@health.ucsd.edu

Gerald Henderson

858-534-4811gehenderson@health.ucsd.edu

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Khushbu Singh, MBBS, CCRP

858-246-2604

Principal Investigator:

Loren Mell, MD

UCSD Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Gerald Henderson, BA

858-822-5223gehenderson@ucsd.edu

More Information

Sponsor

Loren Mell, MD

Last update posted

Feb 10, 2023

Last verified

Feb, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loren Mell, MD on 2023-02-10.