Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy

NCT ID: NCT02229539

Last Updated: 2025-05-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-18

Study Completion Date

2019-03-15

Brief Summary

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The purpose of this study is to test whether a mouthwash made with a drug called doxepin can reduce the pain caused by mouth sores resulting from radiation therapy. A number of mouth rinse preparations exist for patients with treatment-related oral mucositis pain such as the DLA rinse, an over-the-counter medication. This study will evaluate the effects of doxepin compared to DLA (diphenhydramine, lidocaine and antacids) and placebo.Doxepin is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety, long-term pain management, as well as management of rash.

Detailed Description

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Patients are stratified according to sex (male vs. female), concurrent use of chemotherapy (no vs. yes), patient age at registration (\< 60 years old vs. ≥ 60 years old and RTOG acute radiation morbidity criteria (1 vs. 2 vs 3 or more). Protocol therapy will consist of 2 cycles. Patients are randomized to one of three treatment regimens, which include doxepin, DLA and placebo. Cycle One will consist of one day. The care provider or nurse will confirm that the oral pain is at least 4 out of 10 severity level at the time of the rinse on the first day of the study. Patient will be asked to complete the baseline evaluation in the Oral Symptoms booklet. If the pain score is less than 4 then administration will be delayed until the pain is at least 4. Cycle Two will consist of an optional continuation phase lasting up to 7 days. Initiation of the Cycle 2/Continuation Phase may be delayed up to one week after Cycle 1/Day 1.

Primary Objective:

1\. Determine whether the doxepin rinse or DLA rinse is more effective than placebo in reducing OM-related pain in patients undergoing RT to the oral cavity, as measured by a patient-reported questionnaire at baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours.

Secondary Objectives:

1. Assess the adverse event profile of the doxepin rinse, the DLA rinse agent, and the placebo using a patient-reported questionnaire at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours for domains of unpleasant taste, burning or stinging discomfort, and drowsiness.
2. Compare the incidence of using additional analgesics between 1 and 4 hours after the initial mouthwash, between the doxepin oral rinse, the DLA rinse agent, and the placebo arms.
3. Compare the length of time that each study product is used by patients in the one-week continuation phase.
4. Compare the daily pain scores in the one-week continuation phase for the three study arms.
5. Compare the 24-hour morphine equivalent dose used in the continuation phase for the three study arms.

Conditions

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Acute Oral Mucositis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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doxepin 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.

Group Type EXPERIMENTAL

doxepin hydrochloride oral solution

Intervention Type DRUG

2.5 mL (25 mg) doxepin and 2.5 mL water administered orally

DLA (diphenhydramine, lidocaine and antacid) rinse

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.

Group Type ACTIVE_COMPARATOR

DLA (diphenhydramine, lidocaine and antacids) rinse

Intervention Type DRUG

5.0 mL administered orally

placebo rinse

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2.5 mL placebo and 2.5 mL water administered orally

Interventions

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doxepin hydrochloride oral solution

2.5 mL (25 mg) doxepin and 2.5 mL water administered orally

Intervention Type DRUG

DLA (diphenhydramine, lidocaine and antacids) rinse

5.0 mL administered orally

Intervention Type DRUG

Placebo

2.5 mL placebo and 2.5 mL water administered orally

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

13. Age ≥ 18 years
14. ECOG Performance Status 0, 1, or 2
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Miller, MD, MS

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Site Status

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status

Alaska Regional Hospital

Anchorage, Alaska, United States

Site Status

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Epic Care-Dublin

Dublin, California, United States

Site Status

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status

Comprehensive Cancer Care and Research Institute of Colorado LLC

Englewood, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Tumor Institute CCOP

Oakland, California, United States

Site Status

Hematology and Oncology Associates-Oakland

Oakland, California, United States

Site Status

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Exempla Saint Joseph Hospital

Denver, Colorado, United States

Site Status

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status

Mercy Medical Center

Durango, Colorado, United States

Site Status

Southwest Oncology PC

Durango, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

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Mountain Blue Cancer Care Center

Golden, Colorado, United States

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North Colorado Medical Center

Greeley, Colorado, United States

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Rocky Mountain Cancer Centers-Greenwood Village

Greenwood Village, Colorado, United States

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Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Site Status

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status

Littleton Adventist Hospital

Littleton, Colorado, United States

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Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

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Sky Ridge Medical Center

Lone Tree, Colorado, United States

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Longmont United Hospital

Longmont, Colorado, United States

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Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

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McKee Medical Center

Loveland, Colorado, United States

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Parker Adventist Hospital

Parker, Colorado, United States

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Rocky Mountain Cancer Centers-Parker

Parker, Colorado, United States

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Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

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Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, United States

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Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

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Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

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Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

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Middlesex Hospital

Middletown, Connecticut, United States

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Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, United States

Site Status

Morton Plant Hospital

Clearwater, Florida, United States

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Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

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Mount Sinai Medical Center

Miami Beach, Florida, United States

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Memorial Hospital West

Pembroke Pines, Florida, United States

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Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

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Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

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Saint Luke's Mountain States Tumor Institute

Boise, Idaho, United States

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Saint Luke's Mountain States Tumor Institute - Fruitland

Fruitland, Idaho, United States

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Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, United States

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Saint Luke's Mountain States Tumor Institute - Nampa

Nampa, Idaho, United States

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Saint Luke's Mountain States Tumor Institute-Twin Falls

Twin Falls, Idaho, United States

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Illinois CancerCare - Bloomington

Bloomington, Illinois, United States

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Saint Joseph Medical Center

Bloomington, Illinois, United States

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Illinois CancerCare - Canton

Canton, Illinois, United States

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Memorial Hospital of Carbondale

Carbondale, Illinois, United States

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Centralia Oncology Clinic

Centralia, Illinois, United States

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Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

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Decatur Memorial Hospital

Decatur, Illinois, United States

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Heartland Cancer Research NCORP

Decatur, Illinois, United States

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Crossroads Cancer Center

Effingham, Illinois, United States

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Illinois CancerCare - Eureka

Eureka, Illinois, United States

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Illinois CancerCare - Galesburg

Galesburg, Illinois, United States

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Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

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Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, United States

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Illinois CancerCare - Macomb

Macomb, Illinois, United States

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Garneau, Stewart C MD (UIA Investigator)

Moline, Illinois, United States

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Spector, David MD (UIA Investigator)

Moline, Illinois, United States

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Trinity Medical Center

Moline, Illinois, United States

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Illinois CancerCare- Ottawa Clinic

Ottawa, Illinois, United States

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Radiation Oncology of Northern Illinois

Ottawa, Illinois, United States

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Illinois CancerCare-Pekin

Pekin, Illinois, United States

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Pekin Cancer Treatment Center

Pekin, Illinois, United States

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Methodist Medical Center of Illinois

Peoria, Illinois, United States

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OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC

Peoria, Illinois, United States

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Illinois CancerCare-Peoria

Peoria, Illinois, United States

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OSF St. Francis Medical Center

Peoria, Illinois, United States

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Illinois CancerCare-Peru

Peru, Illinois, United States

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Valley Radiation Oncology

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

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OSF Saint Anthony Medical Center

Rockford, Illinois, United States

Site Status

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

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Springfield Clinic

Springfield, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

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Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, United States

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Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, United States

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Memorial Hospital of South Bend

South Bend, Indiana, United States

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Constantinou, Costas L MD (UIA Investigator)

Bettendorf, Iowa, United States

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Mercy Hospital

Cedar Rapids, Iowa, United States

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Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

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Iowa Methodist Medical Center

Des Moines, Iowa, United States

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Medical Oncology and Hematology Associates - Des Moines

Des Moines, Iowa, United States

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Iowa Lutheran Hospital

Des Moines, Iowa, United States

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Siouxland Regional Cancer Center

Sioux City, Iowa, United States

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Methodist West Hospital

West Des Moines, Iowa, United States

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Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

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Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

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Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

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Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

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Cancer Center of Kansas - Independence

Independence, Kansas, United States

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Cancer Center of Kansas - Kingman

Kingman, Kansas, United States

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Lawrence Memorial Hospital

Lawrence, Kansas, United States

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Cancer Center of Kansas - Liberal

Liberal, Kansas, United States

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Cancer Center of Kansas - Newton

Newton, Kansas, United States

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Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

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Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

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Cancer Center of Kansas - Salina

Salina, Kansas, United States

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Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

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Associates In Womens Health

Wichita, Kansas, United States

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Cancer Center of Kansas - Wichita Medical Arts Tower

Wichita, Kansas, United States

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Cancer Center of Kansas - Main Office

Wichita, Kansas, United States

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Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Maine Medical Center - Bramhall Campus

Portland, Maine, United States

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Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

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Bronson Battle Creek

Battle Creek, Michigan, United States

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Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

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Saint John Hospital and Medical Center

Detroit, Michigan, United States

Site Status

Green Bay Oncology - Escanaba

Escanaba, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

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Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

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Green Bay Oncology - Iron Mountain

Iron Mountain, Michigan, United States

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Allegiance Health

Jackson, Michigan, United States

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Borgess Medical Center

Kalamazoo, Michigan, United States

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West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

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Sparrow Hospital

Lansing, Michigan, United States

Site Status

Saint Mary Mercy Hospital

Livonia, Michigan, United States

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Mercy Health Mercy Campus

Muskegon, Michigan, United States

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Lakeland Community Hospital

Niles, Michigan, United States

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Saint Joseph Mercy Oakland

Pontiac, Michigan, United States

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Saint Joseph Mercy Port Huron

Port Huron, Michigan, United States

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Spectrum Health Reed City Hospital

Reed City, Michigan, United States

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William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, United States

Site Status

Saint Mary's of Michigan

Saginaw, Michigan, United States

Site Status

Lakeland Hospital

Saint Joseph, Michigan, United States

Site Status

Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Munson Medical Center

Traverse City, Michigan, United States

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William Beaumont Hospital - Troy

Troy, Michigan, United States

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Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Sanford Clinic North-Bemidji

Bemidji, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

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Mayo Clinic

Rochester, Minnesota, United States

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Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

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Regions Hospital

Saint Paul, Minnesota, United States

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United Hospital

Saint Paul, Minnesota, United States

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Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

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Lakeview Hospital

Stillwater, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Central Care Center - Carrie J. Babb Cancer Center

Bolivar, Missouri, United States

Site Status

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, United States

Site Status

Cox Cancer Center Branson

Branson, Missouri, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status

Capital Region Medical Center-Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Site Status

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status

Phelps County Regional Medical Center

Rolla, Missouri, United States

Site Status

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status

Cancer Research for the Ozarks NCORP

Springfield, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

Cox Health South Hospital

Springfield, Missouri, United States

Site Status

Saint Louis Cancer and Breast Institute - South City

St Louis, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

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Missouri Baptist Medical Center

St Louis, Missouri, United States

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Barnes-Jewish West County Hospital

St Louis, Missouri, United States

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Mercy Hospital Saint Louis

St Louis, Missouri, United States

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Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

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Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, United States

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Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

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Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

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21st Century Oncology-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

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University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

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Cancer and Blood Specialists-Henderson

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

21st Century Oncology

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

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HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, United States

Site Status

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, United States

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Cancer and Blood Specialists-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

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HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

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Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

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21st Century Oncology-Fort Apache

Las Vegas, Nevada, United States

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Cancer and Blood Specialists-Fort Apache

Las Vegas, Nevada, United States

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HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, United States

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Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

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Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

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Veterans Affairs Western New York Health Care System-Buffalo

Buffalo, New York, United States

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Roswell Park Cancer Institute

Buffalo, New York, United States

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North Shore-LIJ Health System/Center for Advanced Medicine

New Hyde Park, New York, United States

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Randolph Hospital

Asheboro, North Carolina, United States

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Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

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Carolina Surgical Clinic of Charlotte PA

Charlotte, North Carolina, United States

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Oncology Specialists of Charlotte

Charlotte, North Carolina, United States

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Southern Oncology Specialists-Charlotte

Charlotte, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

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CaroMont Regional Medical Center

Gastonia, North Carolina, United States

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Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

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Wayne Memorial Hospital

Goldsboro, North Carolina, United States

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Cone Health Cancer Center

Greensboro, North Carolina, United States

Site Status

Hendersonville Hematology and Oncology at Pardee

Hendersonville, North Carolina, United States

Site Status

Margaret R Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Lake Norman Hematology Oncology Specialists-Huntersville

Huntersville, North Carolina, United States

Site Status

Southern Oncology Specialists-Huntersville

Huntersville, North Carolina, United States

Site Status

Lake Norman Hematology Oncology Specialists-Huntersville

Huntersville, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Kernersville

Kernersville, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Davidson County

Lexington, North Carolina, United States

Site Status

Matthews Radiation Oncology Center

Matthews, North Carolina, United States

Site Status

Novant Health Cancer Specialists-Matthews

Matthews, North Carolina, United States

Site Status

Lake Norman Hematology Oncology Specialists-Mooresville

Mooresville, North Carolina, United States

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Novant Health Oncology Specialists-Mount Airy

Mount Airy, North Carolina, United States

Site Status

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, United States

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Annie Penn Memorial Hospital

Reidsville, North Carolina, United States

Site Status

Carolina Oncology Associates PA

Salisbury, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Statesville

Statesville, North Carolina, United States

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Novant Health Oncology Specialists-Wilkesboro

Wilkesboro, North Carolina, United States

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Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, United States

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Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

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Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States

Site Status

Winston-Salem Health Care

Winston-Salem, North Carolina, United States

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Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Clinic North-Fargo

Fargo, North Dakota, United States

Site Status

Sanford Medical Center-Fargo

Fargo, North Dakota, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Altru Cancer Center

Grand Forks, North Dakota, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Saint Charles Health System

Bend, Oregon, United States

Site Status

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Providence Oncology and Hematology Care Southeast

Clackamas, Oregon, United States

Site Status

Bay Area Hospital

Coos Bay, Oregon, United States

Site Status

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

Geisinger Medical Center-Cancer Center Hazelton

Hazleton, Pennsylvania, United States

Site Status

Lewistown Hospital

Lewistown, Pennsylvania, United States

Site Status

Geisinger Medical Oncology-Pottsville

Pottsville, Pennsylvania, United States

Site Status

Geisinger Medical Group

State College, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status

AnMed Health Cancer Center

Anderson, South Carolina, United States

Site Status

Beaufort Memorial Hospital

Beaufort, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Easley

Easley, South Carolina, United States

Site Status

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Site Status

Greenville Health System Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States

Site Status

Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, United States

Site Status

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States

Site Status

Avera Saint Luke's Hospital and Cancer Center

Aberdeen, South Dakota, United States

Site Status

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

Martha Jefferson Hospital

Charlottesville, Virginia, United States

Site Status

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, United States

Site Status

Cancer Care Center at Island Hospital

Anacortes, Washington, United States

Site Status

Swedish Cancer Institute-Eastside Oncology Hematology

Bellevue, Washington, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Providence Regional Cancer System-Centralia

Centralia, Washington, United States

Site Status

Swedish Medical Center-Edmonds

Edmonds, Washington, United States

Site Status

Providence Regional Cancer Partnership

Everett, Washington, United States

Site Status

Swedish Medical Center - Issaquah

Issaquah, Washington, United States

Site Status

Providence Regional Cancer System-Lacey

Lacey, Washington, United States

Site Status

Saint John Medical Center

Longview, Washington, United States

Site Status

Minor and James Medical PLLC

Seattle, Washington, United States

Site Status

Pacific Gynecology Specialists

Seattle, Washington, United States

Site Status

Swedish Medical Center-Ballard Campus

Seattle, Washington, United States

Site Status

Group Health Cooperative-Seattle

Seattle, Washington, United States

Site Status

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status

Providence Regional Cancer System-Shelton

Shelton, Washington, United States

Site Status

Rockwood Cancer Treatment Center-DHEC-Downtown

Spokane, Washington, United States

Site Status

Evergreen Hematology and Oncology PS

Spokane, Washington, United States

Site Status

Rockwood Clinic Cancer Treatment Center-Valley

Spokane Valley, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States

Site Status

Providence Regional Cancer System-Yelm

Yelm, Washington, United States

Site Status

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin, United States

Site Status

Marshfield Clinic Cancer Center at Sacred Heart

Eau Claire, Wisconsin, United States

Site Status

Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Site Status

Saint Agnes Hospital/Agnesian Cancer Center

Fond du Lac, Wisconsin, United States

Site Status

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status

Holy Family Memorial Hospital

Manitowoc, Wisconsin, United States

Site Status

Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Saint Joseph's Hospital

Marshfield, Wisconsin, United States

Site Status

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status

Westfields Hospital/Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status

Green Bay Oncology - Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

Marshfield Clinic at James Beck Cancer Center

Rhinelander, Wisconsin, United States

Site Status

Marshfield Clinic-Rice Lake Center

Rice Lake, Wisconsin, United States

Site Status

Saint Nicholas Hospital

Sheboygan, Wisconsin, United States

Site Status

Marshfield Clinic at Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status

Door County Cancer Center

Sturgeon Bay, Wisconsin, United States

Site Status

Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Marshfield Clinic-Wausau Center

Wausau, Wisconsin, United States

Site Status

Diagnostic and Treatment Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Saint Clare's Hospital

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, United States

Site Status

Countries

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United States

References

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Sio TT, Le-Rademacher JG, Leenstra JL, Loprinzi CL, Rine G, Curtis A, Singh AK, Martenson JA Jr, Novotny PJ, Tan AD, Qin R, Ko SJ, Reiter PL, Miller RC. Effect of Doxepin Mouthwash or Diphenhydramine-Lidocaine-Antacid Mouthwash vs Placebo on Radiotherapy-Related Oral Mucositis Pain: The Alliance A221304 Randomized Clinical Trial. JAMA. 2019 Apr 16;321(15):1481-1490. doi: 10.1001/jama.2019.3504.

Reference Type DERIVED
PMID: 30990550 (View on PubMed)

Other Identifiers

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U10CA037447

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1CA189823

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2014-01877

Identifier Type: REGISTRY

Identifier Source: secondary_id

A221304

Identifier Type: -

Identifier Source: org_study_id

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