Trials / Terminated

TerminatedNCT04162873

Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

RESILIENCE: Effect of Comprehensive Celecoxib Through Treatment for Advanced-Stage Head and Neck Cancer: A Randomized, Double-Blinded, Placebo-Controlled Trial

Status: Terminated
Phase: Phase 2
Study type: Interventional
Enrollment: 13 (actual)

Sponsor: University of Utah · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well celecoxib works through surgery and radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced). Celecoxib is Food and Drug Administration approved to treat arthritis, acute pain, and painful menstrual periods. Adding celecoxib to standard of care treatment may help to decrease the amount of time between surgery and radiation therapy.

Detailed description

PRIMARY OBJECTIVE: I. To assess the number of days from surgery to initiation of radiation with the addition of celecoxib compared to placebo. SECONDARY OBJECTIVES: I. To assess overall pain control and management for patients on celecoxib compared to placebo. * Subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. * Patient satisfaction with pain control questionnaire. * Narcotic consumption in daily total morphine equivalents averaged over a week. II. To assess functional outcomes for patients on celecoxib compared to placebo. III. To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo. IV. To assess the average number of treatment days missed during adjuvant radiation for patients on celecoxib compared to placebo. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive celecoxib orally (PO) or via feeding tube twice daily (BID) starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO or via feeding tube BID starting 5 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.

Conditions

Interventions

Type	Name	Description
DRUG	Celecoxib	Given PO or via feeding tube
OTHER	Placebo	Given PO or via feeding tube
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

Start date: 2019-11-27
Primary completion: 2023-02-28
Completion: 2023-04-26
First posted: 2019-11-14
Last updated: 2025-02-12
Results posted: 2025-02-12

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04162873. Inclusion in this directory is not an endorsement.