Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Acute Oral Mucositis Pain
About this trial
This is an interventional treatment trial for Acute Oral Mucositis Pain
Eligibility Criteria
- Documentation of Disease: Histologic documentation of malignancy currently undergoing a course of RT (with or without chemotherapy) including the oral cavity and/or oropharyngeal area to a dose of at least 4500 cGy using more than 5 fractions (i.e., stereotactic body radiation therapy [SBRT] is not allowed).
- Physical exam demonstrating evidence of radiotherapy-related mucositis in the visible oral cavity and/or oropharynx consistent with mucous membrane toxicity greater than 0 using the Acute Radiation Morbidity Scoring Criteria.
At least 4 (out of 10) patient-reported oral pain related to oral mucositis secondary to RT for which the patient seeks relief, as measured on the Oral Pain Assessment.
Note: The pain score must be at least 4 at the time that the patient starts the first dose of study medication. The patient may be enrolled to the study if s/he, at times, has a pain score of at least 4, so long as initiation of study treatment begins when the pain score is at least 4.
- Ability to complete questionnaire(s) by themselves or with assistance.
- No known allergy to diphenhydramine, lidocaine, antacid (aluminum hydroxide, magnesium hydroxide, and simethicone), doxepin, tricyclic antidepressants, or any known component of the drug formulation in the testing arms.
- No use of any anti-arrhythmic medication (except for beta-blockers) including lidocaine, linezolid, ipratropium, or medications with high anti-cholinergic potency (including neostigmine, a tricyclic antidepressant or a monoamine oxidase inhibitor) within 2 weeks prior to registration.
- No current diagnosed untreated or unresolved oral candidiasis or oral HSV infection.
- No history of untreated narrow angle glaucoma within 6 weeks prior to registration.
- No untreated urinary retention within 6 weeks prior to registration.
- No current use of glutamine or sucralfate powders at the time of registration (no washout required).
- No cryotherapy for prophylactic mucosal protection within 6 weeks prior to registration.
- Not pregnant, because patients eligible for this study will be receiving radiotherapy, which has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required.
- Age ≥ 18 years
- ECOG Performance Status 0, 1, or 2
Sites / Locations
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Contra Costa Regional Medical Center
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute CCOP
- Hematology and Oncology Associates-Oakland
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Colorado Blood Cancer Institute
- Mercy Medical Center
- Southwest Oncology PC
- Swedish Medical Center
- Mountain Blue Cancer Care Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- Rocky Mountain Cancer Centers-Thornton
- Exempla Lutheran Medical Center
- Saint Francis Hospital and Medical Center
- Middlesex Hospital
- Veterans Affairs Medical Center - Washington, DC
- Morton Plant Hospital
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Mount Sinai Medical Center
- Memorial Hospital West
- Saint Joseph's Hospital/Children's Hospital-Tampa
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Luke's Mountain States Tumor Institute - Nampa
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Illinois CancerCare - Bloomington
- Saint Joseph Medical Center
- Illinois CancerCare - Canton
- Memorial Hospital of Carbondale
- Centralia Oncology Clinic
- Cancer Care Specialists of Central Illinois
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Crossroads Cancer Center
- Illinois CancerCare - Eureka
- Illinois CancerCare - Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare - Kewanee Clinic
- Illinois CancerCare - Macomb
- Garneau, Stewart C MD (UIA Investigator)
- Spector, David MD (UIA Investigator)
- Trinity Medical Center
- Illinois CancerCare- Ottawa Clinic
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- Pekin Cancer Treatment Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
- Illinois CancerCare-Peoria
- OSF St. Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- OSF Saint Anthony Medical Center
- Central Illinois Hematology Oncology Center
- Springfield Clinic
- Memorial Medical Center
- Cancer Care Specialists of Illinois-Swansea
- Memorial Regional Cancer Center Day Road
- Memorial Hospital of South Bend
- Constantinou, Costas L MD (UIA Investigator)
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates - Des Moines
- Iowa Lutheran Hospital
- Siouxland Regional Cancer Center
- Methodist West Hospital
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas - Independence
- Cancer Center of Kansas - Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas - Liberal
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Pratt
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas - Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wesley Medical Center
- Cancer Center of Kansas - Winfield
- Maine Medical Center - Bramhall Campus
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- Oakwood Hospital and Medical Center
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Mercy Health Mercy Campus
- Lakeland Community Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Spectrum Health Reed City Hospital
- William Beaumont Hospital - Royal Oak
- Saint Mary's of Michigan
- Lakeland Hospital
- Marie Yeager Cancer Center
- Munson Medical Center
- William Beaumont Hospital - Troy
- Saint John Macomb-Oakland Hospital
- Sanford Clinic North-Bemidji
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Central Care Center - Carrie J. Babb Cancer Center
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Capital Region Medical Center-Goldschmidt Cancer Center
- Mercy Clinic-Rolla-Cancer and Hematology
- Phelps County Regional Medical Center
- Saint Louis Cancer and Breast Institute - South City
- Washington University School of Medicine
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Barnes-Jewish West County Hospital
- Mercy Hospital Saint Louis
- Sainte Genevieve County Memorial Hospital
- Cancer Research for the Ozarks NCORP
- Mercy Hospital Springfield
- Cox Health South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Comprehensive Cancer Centers of Nevada - Henderson
- Las Vegas Cancer Center-Henderson
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- University Medical Center of Southern Nevada
- Cancer and Blood Specialists-Henderson
- Nevada Cancer Research Foundation NCORP
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- 21st Century Oncology-Vegas Tenaya
- Cancer and Blood Specialists-Shadow
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- Comprehensive Cancer Centers of Nevada-Summerlin
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Cancer and Blood Specialists-Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- Comprehensive Cancer Centers of Nevada
- Veterans Affairs Western New York Health Care System-Buffalo
- Roswell Park Cancer Institute
- North Shore-LIJ Health System/Center for Advanced Medicine
- Randolph Hospital
- Novant Health Presbyterian Medical Center
- Carolina Surgical Clinic of Charlotte PA
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Southeastern Medical Oncology Center-Clinton
- CaroMont Regional Medical Center
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Cone Health Cancer Center
- Hendersonville Hematology and Oncology at Pardee
- Margaret R Pardee Memorial Hospital
- Lake Norman Hematology Oncology Specialists-Huntersville
- Southern Oncology Specialists-Huntersville
- Lake Norman Hematology Oncology Specialists-Huntersville
- Southeastern Medical Oncology Center-Jacksonville
- Novant Health Oncology Specialists-Kernersville
- Novant Health Oncology Specialists-Davidson County
- Matthews Radiation Oncology Center
- Novant Health Cancer Specialists-Matthews
- Lake Norman Hematology Oncology Specialists-Mooresville
- Novant Health Oncology Specialists-Mount Airy
- FirstHealth of the Carolinas-Moore Regional Hospital
- Annie Penn Memorial Hospital
- Carolina Oncology Associates PA
- Novant Health Oncology Specialists-Statesville
- Novant Health Oncology Specialists-Wilkesboro
- Southeastern Medical Oncology Center-Wilson
- Novant Health Forsyth Medical Center
- Novant Health Oncology Specialists
- Winston-Salem Health Care
- Sanford Bismarck Medical Center
- Sanford Clinic North-Fargo
- Sanford Medical Center-Fargo
- Sanford Roger Maris Cancer Center
- Altru Cancer Center
- Mercy Hospital Oklahoma City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Oncology and Hematology Care Southeast
- Bay Area Hospital
- Providence Newberg Medical Center
- Providence Willamette Falls Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Geisinger Medical Center
- Adams Cancer Center
- Geisinger Medical Center-Cancer Center Hazelton
- Lewistown Hospital
- Geisinger Medical Oncology-Pottsville
- Geisinger Medical Group
- Geisinger Wyoming Valley/Henry Cancer Center
- WellSpan Health-York Hospital
- AnMed Health Cancer Center
- Beaufort Memorial Hospital
- Greenville Health System Cancer Institute-Easley
- Gibbs Cancer Center-Gaffney
- Greenville Health System Cancer Institute - Butternut
- Greenville Health System Cancer Institute-Andrews
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Gibbs Cancer Center-Pelham
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Medical Center
- Greenville Health System Cancer Institute-Spartanburg
- Avera Saint Luke's Hospital and Cancer Center
- Sanford Cancer Center Oncology Clinic
- Avera Cancer Institute
- Sanford USD Medical Center - Sioux Falls
- Martha Jefferson Hospital
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- Swedish Cancer Institute-Eastside Oncology Hematology
- PeaceHealth Saint Joseph Medical Center
- Providence Regional Cancer System-Centralia
- Swedish Medical Center-Edmonds
- Providence Regional Cancer Partnership
- Swedish Medical Center - Issaquah
- Providence Regional Cancer System-Lacey
- Saint John Medical Center
- Minor and James Medical PLLC
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- Providence Regional Cancer System-Shelton
- Rockwood Clinic Cancer Treatment Center-Valley
- Rockwood Cancer Treatment Center-DHEC-Downtown
- Evergreen Hematology and Oncology PS
- PeaceHealth Southwest Medical Center
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- Marshfield Clinic-Chippewa Center
- Marshfield Clinic Cancer Center at Sacred Heart
- Sacred Heart Hospital
- Saint Agnes Hospital/Agnesian Cancer Center
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Mayo Clinic Health System-Franciscan Healthcare
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Marshfield Clinic
- Saint Joseph's Hospital
- Marshfield Clinic-Minocqua Center
- Westfields Hospital/Cancer Center of Western Wisconsin
- Green Bay Oncology - Oconto Falls
- Marshfield Clinic at James Beck Cancer Center
- Marshfield Clinic-Rice Lake Center
- Saint Nicholas Hospital
- Marshfield Clinic at Saint Michael's Hospital
- Saint Michael's Hospital
- Door County Cancer Center
- Green Bay Oncology - Sturgeon Bay
- Marshfield Clinic-Wausau Center
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Saint Clare's Hospital
- Marshfield Clinic - Wisconsin Rapids Center
- Cheyenne Regional Medical Center-West
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Placebo Comparator
doxepin rinse
DLA (diphenhydramine, lidocaine and antacid) rinse
placebo rinse
Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally. Doxepin rinse is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients randomized to doxepin or placebo, they and their caregivers will continue to be blinded to the treatment. Patients will complete the Oral Symptoms booklet per the protocol.
Patients receive 5.0 mL DLA orally. DLA is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients receiving DLA during the continuation phase of the study, they and/or caregivers may be aware that they are receiving DLA. Patients will complete the Oral Symptoms booklet per the protocol.
Patients receive 2.5 mL placebo and 2.5 mL water orally. The placebo rinse is administered in the clinic on Day 1 (Cycle 1). There is an optional continuation phase within seven days following Day 1 (Cycle 1), patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2) where the patient takes the rinse at home every 4 hours. Chemotherapy is allowed during the continuation phase. Patients randomized to doxepin or placebo, they and their caregivers will continue to be blinded to the treatment. Patients will complete the Oral Symptoms booklet per the protocol.