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Completed Phase 3 Interventional Results available

Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy

ClinicalTrials.gov ID: NCT01156142

Public ClinicalTrials.gov record NCT01156142. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 7:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

RATIONALE: Doxepin hydrochloride may be an effective treatment for oral mucositis pain in patients undergoing radiation therapy with or without chemotherapy. PURPOSE: This randomized phase III trial is studying doxepin hydrochloride to see how well it works compared to placebo in treating oral mucositis pain in patients with head and neck cancer undergoing radiation therapy with or without chemotherapy.

Study identification

NCT ID
NCT01156142
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
155 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2010 (Type not available)
Primary completion
May 2012 (Actual)
Completion
Mar 2, 2015 (Actual)
Last update posted
Aug 9, 2017

2010 – 2015

United States locations

U.S. sites
120
U.S. states
16
U.S. cities
80
Facility City State ZIP Site status
Mayo Clinic Scottsdale Scottsdale Arizona 85259-5499 —
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford Connecticut 06105 —
Mayo Clinic - Jacksonville Jacksonville Florida 32224 —
MBCCOP - Medical College of Georgia Cancer Center Augusta Georgia 30912 —
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Boise Idaho 83706 —
CCOP - Carle Cancer Center Urbana Illinois 61801 —
Elkhart Clinic, LLC Elkhart Indiana 46514-2098 —
Michiana Hematology-Oncology, PC - Elkhart Elkhart Indiana 46514 —
Elkhart General Hospital Elkhart Indiana 46515 —
Howard Community Hospital Kokomo Indiana 46904 —
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana 46350 —
Indiana University Health La Porte Hospital La Porte Indiana 46350 —
Michiana Hematology-Oncology, PC - South Bend Mishawaka Indiana 46545-1470 —
Saint Joseph Regional Medical Center Mishawaka Indiana 46545-1470 —
Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana 46545 —
Michiana Hematology Oncology PC - Plymouth Plymouth Indiana 46563 —
CCOP - Northern Indiana CR Consortium South Bend Indiana 46601 —
Memorial Hospital of South Bend South Bend Indiana 46601 —
Michiana Hematology Oncology PC - La Porte Westville Indiana 46391 —
McFarland Clinic, PC Ames Iowa 50010 —
Cedar Rapids Oncology Associates Cedar Rapids Iowa 52403 —
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids Iowa 52403 —
Boston University Cancer Research Center Boston Massachusetts 02118 —
Hickman Cancer Center at Bixby Medical Center Adrian Michigan 49221 —
Saint Joseph Mercy Cancer Center Ann Arbor Michigan 48106-0995 —
CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan 48106 —
Battle Creek Health System Cancer Care Center Battle Creek Michigan 49017 —
Mecosta County Medical Center Big Rapids Michigan 49307 —
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn Michigan 48123-2500 —
Saint John Hospital and Medical Center Detroit Michigan 48236 —
Genesys Hurley Cancer Institute Flint Michigan 48503 —
Hurley Medical Center Flint Michigan 48503 —
Genesys Regional Medical Center Grand Blanc Michigan 48439 —
Butterworth Hospital at Spectrum Health Grand Rapids Michigan 49503 —
CCOP - Grand Rapids Grand Rapids Michigan 49503 —
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan 49503 —
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods Michigan 48236 —
Allegiance Health Jackson Michigan 49201 —
Foote Memorial Hospital Jackson Michigan 49201 —
Sparrow Regional Cancer Center Lansing Michigan 48912-1811 —
St. Mary Mercy Hospital Livonia Michigan 48154 —
Community Cancer Center of Monroe Monroe Michigan 48162 —
Mercy Memorial Hospital - Monroe Monroe Michigan 48162 —
Mercy General Health Partners Muskegon Michigan 49444 —
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 —
Lakeland Regional Cancer Care Center - St. Joseph Saint Joseph Michigan 49085 —
Lakeside Cancer Specialists, PLLC Saint Joseph Michigan 49085 —
Marie Yeager Cancer Center Saint Joseph Michigan 49085 —
Munson Medical Center Traverse City Michigan 49684 —
St. John Macomb Hospital Warren Michigan 48093 —
MeritCare Bemidji Bemidji Minnesota 56601 —
Sanford Clinic North-Bemidgi 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 —
Minnesota Oncology - Maplewood Maplewood Minnesota 55109 —
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota 55407 —
Hennepin County Medical Center - Minneapolis Minneapolis Minnesota 55415 —
New Ulm Medical Center New Ulm Minnesota 56073 —
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota 55422-2900 —
Mayo Clinic Cancer Center Rochester Minnesota 55905 —
CCOP - Metro-Minnesota Saint Louis Park Minnesota 55416 —
Park Nicollet Cancer Center Saint Louis Park Minnesota 55416 —
Regions Hospital Cancer Care Center Saint Paul Minnesota 55101 —
United Hospital Saint Paul Minnesota 55102 —
St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota 55379 —
Lakeview Hospital Stillwater Minnesota 55082 —
Ridgeview Medical Center Waconia Minnesota 55387 —
Willmar Cancer Center at Rice Memorial Hospital Willmar Minnesota 56201 —
Minnesota Oncology - Woodbury Woodbury Minnesota 55125 —
Cancer Resource Center - Lincoln Lincoln Nebraska 68510 —
CCOP - Missouri Valley Cancer Consortium Omaha Nebraska 68106 —
Immanuel Medical Center Omaha Nebraska 68122 —
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha Nebraska 68124 —
Lakeside Hospital Omaha Nebraska 68130 —
Creighton University Medical Center Omaha Nebraska 68131-2197 —
MeritCare Broadway Fargo North Dakota 58102 —
Sanford Clinic North-Fargo Fargo North Dakota 58102 —
CCOP - MeritCare Hospital Fargo North Dakota 58122 —
Roger Maris Cancer Center at MeritCare Hospital Fargo North Dakota 58122 —
Sanford Medical Center-Fargo Fargo North Dakota 58122 —
Altru Cancer Center at Altru Hospital Grand Forks North Dakota 58201 —
Wood County Oncology Center Bowling Green Ohio 43402 —
Community Cancer Center Elyria Ohio 44035 —
Hematology Oncology Center Elyria Ohio 44035 —
Lima Memorial Hospital Lima Ohio 45804 —
Northwest Ohio Oncology Center Maumee Ohio 43537-1839 —
St. Charles Mercy Hospital Oregon Ohio 43616 —
Toledo Clinic - Oregon Oregon Ohio 43616 —
Flower Hospital Cancer Center Sylvania Ohio 43560 —
Mercy Hospital of Tiffin Tiffin Ohio 44883 —
Toledo Hospital Toledo Ohio 43606 —
St. Vincent Mercy Medical Center Toledo Ohio 43608 —
Medical University of Ohio Cancer Center Toledo Ohio 43614 —
CCOP - Toledo Community Hospital Toledo Ohio 43617 —
St. Anne Mercy Hospital Toledo Ohio 43623 —
Toledo Clinic, Incorporated - Main Clinic Toledo Ohio 43623 —
Fulton County Health Center Wauseon Ohio 43567 —
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 —
Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin 54848 —
Marshfield Clinic - Marshfield Center Marshfield Wisconsin 54449 —
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 - Indianhead Center Rice Lake Wisconsin 54868 —
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 —
Diagnostic and Treatment Center Weston Wisconsin 54476 —
Marshfield Clinic - Weston Center Weston Wisconsin 54476 —
Ministry Saint Clare's Hospital Weston Wisconsin 54476 —
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin 54494 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01156142, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 9, 2017 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01156142 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →