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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
Open (Enrolling)
Both
Head and Neck Cancer, Mucositis, Oral Complications of Radiation Therapy, Pain

Thank you

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 ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
MeritCare BemidjiBemidji, Minnesota  56601
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
CCOP - Grand RapidsGrand Rapids, Michigan  49503
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Munson Medical CenterTraverse City, Michigan  49684
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Mecosta County Medical CenterBig Rapids, Michigan  49307
Community Cancer Center of MonroeMonroe, Michigan  48162
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Wood County Oncology CenterBowling Green, Ohio  43402
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
McFarland Clinic, PCAmes, Iowa  50010
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Hematology Oncology CenterElyria, Ohio  44035
Community Cancer CenterElyria, Ohio  44035
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Marshfield Clinic - Chippewa CenterChippewa Falls, Wisconsin  54729
Center for Cancer Treatment & Prevention at Sacred Heart HospitalEau Claire, Wisconsin  54701
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Saint Michael's Hospital Cancer CenterStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Diagnostic and Treatment CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Boston University Cancer Research CenterBoston, Massachusetts  02118
Mercy General Health PartnersMuskegon, Michigan  49443
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Lakeside HospitalOmaha, Nebraska  68130
New Ulm Medical CenterNew Ulm, Minnesota  56073
Roger Maris Cancer Center at MeritCare HospitalFargo, North Dakota  58122
Marshfield Clinic - Ladysmith CenterLadysmith, Wisconsin  54848
Ministry Saint Clare's HospitalWeston, Wisconsin  54476