A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Mucositis, Oral Complications of Radiation Therapy, Pain
Both
Head and Neck Cancer, Mucositis, Oral Complications of Radiation Therapy, Pain
Trial Information
A Randomized Double-Blind Study of Doxepin Rinse Versus Placebo in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
OBJECTIVES:
Primary
- Determine whether doxepin hydrochloride mouth rinse, compared to placebo, is effective
in reducing oral mucositis-related pain in patients with head and neck cancer
undergoing radiotherapy with or without chemotherapy.
Secondary
- Assess the adverse event profile of these regimens, using a patient-reported
questionnaire at 5, 15, 30, 60, 120, and 240 minutes, in these patients.
- Compare the incidence of using alternative analgesics 4 hours before and in between
these regimens in these patients.
- Assess patient preference for continuing therapy with oral doxepin hydrochloride after
initial test rinse or after optional cross-over phase.
Tertiary
- Assess pain reduction and other adverse event profile in patients who cross-over to the
optional blinded phase using the same patient-reported questionnaire.
- Assess pain reduction and other adverse event profile in patients who continue to
receive optional oral doxepin hydrochloride.
OUTLINE: This is a multicenter study. Patients are stratified according to gender,
concurrent radiosensitizing chemotherapy (yes vs no), and age (< 60 years vs ≥ 60 years).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxepin hydrochloride oral rinse (swish, gargle, and spit)*
over 1 minute on day 1. Patients may crossover to arm II on day 2.
- Arm II: Patients receive placebo oral rinse (swish, gargle, and spit)* over 1 minute on
day 1. Patients may crossover to arm I on day 2.
NOTE: * Patients are instructed to avoid taking medications for mucositis pain 60 minutes
before and after study medication.
After completing study therapy, patients have the option to receive doxepin hydrochloride
oral rinse every 4 hours as needed during radiotherapy.
Patients complete questionnaires at baseline, and at 5, 15, 30, 60, 120, and 240 minutes
after study medication. Patients who choose to continue doxepin hydrochloride oral rinse
also complete weekly questionnaires.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed head and neck cancer meeting the following criteria:
- Undergoing radiotherapy with or without chemotherapy
- At least 1/3 of the oral cavity mucosa must be included in the radiotherapy
field
- Oral pain related to mucositis of ≥ grade 4 and for which the patient wants relief as
measured by patient response to a pain scale question rating (0 to 10)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- No known allergy to doxepin hydrochloride, tricyclic antidepressants, or any known
component of the drug formulation
- No untreated or unresolved oral candidiasis or oral herpes simplex virus infection
- No untreated narrow-angle glaucoma
- No untreated urinary retention in the past 6 weeks
- No co-morbid systemic illnesses or other severe concurrent disease that, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study, or interfere significantly with proper assessment of safety and toxicity
of the prescribed regimens
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 2 weeks since prior tricyclic antidepressant or monoamine oxidase inhibitor
- No viscous lidocaine, 'magic mouthwash', benzocaine, diphenhydramine, or other
medicated oral rinse within 4 hours before or after the study medication
- Normal saline or baking soda rinse allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Total pain reduction (mouth and throat)
Safety Issue:
No
Principal Investigator
Robert C. Miller, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
Unspecified
Study ID:
CDR0000675520
NCT ID:
NCT01156142
Start Date:
December 2010
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Mucositis
- Oral Complications of Radiation Therapy
- Pain
- oral complications of radiation therapy
- mucositis
- pain
- stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent verrucous carcinoma of the larynx
- stage I squamous cell carcinoma of the larynx
- stage I verrucous carcinoma of the larynx
- stage II squamous cell carcinoma of the larynx
- stage II verrucous carcinoma of the larynx
- stage III squamous cell carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- recurrent adenoid cystic carcinoma of the oral cavity
- recurrent mucoepidermoid carcinoma of the oral cavity
- recurrent verrucous carcinoma of the oral cavity
- stage I adenoid cystic carcinoma of the oral cavity
- stage I mucoepidermoid carcinoma of the oral cavity
- stage I verrucous carcinoma of the oral cavity
- stage II adenoid cystic carcinoma of the oral cavity
- stage II mucoepidermoid carcinoma of the oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage III adenoid cystic carcinoma of the oral cavity
- stage III mucoepidermoid carcinoma of the oral cavity
- stage III verrucous carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- stage IV verrucous carcinoma of the oral cavity
- stage I squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- recurrent basal cell carcinoma of the lip
- recurrent squamous cell carcinoma of the lip and oral cavity
- stage I basal cell carcinoma of the lip
- stage II basal cell carcinoma of the lip
- stage III basal cell carcinoma of the lip
- stage IV basal cell carcinoma of the lip
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- recurrent metastatic squamous neck cancer with occult primary
- untreated metastatic squamous neck cancer with occult primary
- recurrent lymphoepithelioma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage I lymphoepithelioma of the nasopharynx
- stage I squamous cell carcinoma of the nasopharynx
- stage II lymphoepithelioma of the nasopharynx
- stage II squamous cell carcinoma of the nasopharynx
- stage III lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent lymphoepithelioma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage I lymphoepithelioma of the oropharynx
- stage I squamous cell carcinoma of the oropharynx
- stage II lymphoepithelioma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage I inverted papilloma of the paranasal sinus and nasal cavity
- stage I midline lethal granuloma of the paranasal sinus and nasal cavity
- stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage II inverted papilloma of the paranasal sinus and nasal cavity
- stage II midline lethal granuloma of the paranasal sinus and nasal cavity
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- stage III midline lethal granuloma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- high-grade salivary gland mucoepidermoid carcinoma
- low-grade salivary gland mucoepidermoid carcinoma
- recurrent salivary gland cancer
- salivary gland acinic cell tumor
- salivary gland adenocarcinoma
- salivary gland adenoid cystic carcinoma
- salivary gland anaplastic carcinoma
- salivary gland malignant mixed cell type tumor
- salivary gland poorly differentiated carcinoma
- salivary gland squamous cell carcinoma
- stage I salivary gland cancer
- stage II salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- tongue cancer
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| MeritCare Bemidji | Bemidji, Minnesota 56601 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
| HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
| Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
| Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| MeritCare Broadway | Fargo, North Dakota 58122 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Toledo Hospital | Toledo, Ohio 43606 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Howard Community Hospital | Kokomo, Indiana 46904 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| Community Cancer Center of Monroe | Monroe, Michigan 48162 |
| Immanuel Medical Center | Omaha, Nebraska 68122 |
| Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
| Wood County Oncology Center | Bowling Green, Ohio 43402 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| Toledo Clinic - Oregon | Oregon, Ohio 43616 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
| Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
| Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
| Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
| Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
| Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
| McFarland Clinic, PC | Ames, Iowa 50010 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| St. Mary Mercy Hospital | Livonia, Michigan 48154 |
| Mercy Memorial Hospital - Monroe | Monroe, Michigan 48162 |
| St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
| Hematology Oncology Center | Elyria, Ohio 44035 |
| Community Cancer Center | Elyria, Ohio 44035 |
| Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
| St. Anne Mercy Hospital | Toledo, Ohio 43623 |
| Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
| Marshfield Clinic - Chippewa Center | Chippewa Falls, Wisconsin 54729 |
| Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire, Wisconsin 54701 |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
| Saint Joseph's Hospital | Marshfield, Wisconsin 54449 |
| Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
| Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
| Saint Michael's Hospital Cancer Center | Stevens Point, Wisconsin 54481 |
| Marshfield Clinic - Wausau Center | Wausau, Wisconsin 54401 |
| Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
| Diagnostic and Treatment Center | Weston, Wisconsin 54476 |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
| Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Boston University Cancer Research Center | Boston, Massachusetts 02118 |
| Mercy General Health Partners | Muskegon, Michigan 49443 |
| Minnesota Oncology - Maplewood | Maplewood, Minnesota 55109 |
| Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
| Lakeview Hospital | Stillwater, Minnesota 55082 |
| Minnesota Oncology - Woodbury | Woodbury, Minnesota 55125 |
| Lakeside Hospital | Omaha, Nebraska 68130 |
| New Ulm Medical Center | New Ulm, Minnesota 56073 |
| Roger Maris Cancer Center at MeritCare Hospital | Fargo, North Dakota 58122 |
| Marshfield Clinic - Ladysmith Center | Ladysmith, Wisconsin 54848 |
| Ministry Saint Clare's Hospital | Weston, Wisconsin 54476 |
