Actively Recruiting
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
Led by NRG Oncology · Updated on 2026-05-04
98
Participants Needed
149
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer. Oral mucositis (inflammation and mouth sores) is a common side effect of chemoradiation that can cause pain and difficulty swallowing. Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment. BMX-001 neutralizes harmful substances in the body, preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues. Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer.
CONDITIONS
Official Title
Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients planned to receive radiation and concurrent cisplatin chemotherapy as definitive therapy (not adjuvant therapy).
- At least two oral subsites must have at least 1cc or 1% volume receiving 50 Gy or more radiation.
- Pathologically confirmed squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity.
- Documented p16 and/or HPV status for oropharynx cancer patients.
- No T0, Tx, or unknown primary disease.
- No evidence of metastatic disease related to current diagnosis.
- Able to receive intensity-modulated radiation therapy with daily 2.0 Gy fractions, 5 days a week, totaling 70 Gy.
- Age 18 years or older.
- Zubrod performance status 0 to 2.
- Potassium and magnesium levels at or above institutional lower limits, allowing supplementation.
- Absolute neutrophil count of at least 1,500 cells/mm3.
- Platelet count of at least 100,000 cells/mm3.
- Hemoglobin level at least 9.0 g/dl (transfusions allowed to reach 10.0 g/dl).
- Adequate kidney function with creatinine clearance over 50 mL/min.
- Total bilirubin at or below twice the institutional upper limit (except for Gilbert's syndrome).
- Liver enzymes AST and ALT at or below three times the institutional upper limit.
- No prior radiotherapy overlapping with planned treatment fields.
- No concurrent treatment with nitrates or drugs risking sudden blood pressure drop.
- No prior complete surgical removal of both primary and nodal disease; visible disease must be present.
- No current adjuvant post-operative chemoradiation treatment.
- No systemic treatment with CYP450 inducers or strong inhibitors within 4 days before registration (certain steroid and antifungal treatments allowed).
- No prior induction chemotherapy.
- No unrelated malignancy requiring active current treatment, except specific low-risk cancers.
- No significant hearing impairment preventing cisplatin use.
- No serious cardiovascular or cerebrovascular events within 6 months before enrollment.
- No valvular heart disease.
- No significant vascular disease requiring recent surgery or thrombosis treatment.
- No uncontrolled central nervous system disease unless medically controlled.
- No recent serious infections requiring IV antimicrobials.
- No recent respiratory illness requiring hospitalization.
- No known personal or family history of long QT syndrome or prolonged QTc interval.
- Reversible electrolyte abnormalities to mild levels.
- No poorly controlled high blood pressure.
- No moderate or severe oral mucositis or hypotension.
- No medical need for high-risk anti-arrhythmic medications.
- No allergic reaction to study agents or similar compounds.
- Childbearing potential defined as persons who have had menarche and are not surgically sterilized or postmenopausal.
You will not qualify if you...
- Planned concurrent cisplatin and radiation therapy in the adjuvant setting.
- T0, Tx, or unknown primary disease.
- Evidence of metastatic disease related to current diagnosis.
- Prior radiotherapy overlapping planned treatment fields.
- Concurrent treatment with nitrates or drugs risking sudden blood pressure drop.
- Prior complete surgical removal of all detectable primary and nodal disease.
- Current adjuvant post-operative chemoradiation treatment.
- Systemic treatment with CYP450 inducers or strong inhibitors within 4 days before registration.
- Prior induction chemotherapy treatment.
- Unrelated malignancy requiring active treatment, except certain low-risk cancers.
- Significant hearing impairment precluding cisplatin use.
- Serious cardiovascular or cerebrovascular disease within 6 months prior to enrollment.
- Valvular heart disease.
- Significant vascular disease requiring recent surgical repair or thrombosis treatment.
- Uncontrolled central nervous system disease.
- Acute infection requiring intravenous antimicrobials within 7 days.
- Recent respiratory illness requiring hospitalization within 30 days.
- Known personal or family history of long QT syndrome or prolonged QTc interval.
- Persistent severe electrolyte abnormalities not reversible to mild levels.
- Poorly controlled hypertension over repeated measures.
- Moderate or severe oral mucositis.
- Moderate or severe hypotension.
- Medical necessity for anti-arrhythmic drugs with significant QTc prolongation risk.
- History of allergic reaction to study agents or similar compounds.
AI-Screening
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Trial Site Locations
Total: 149 locations
1
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States, 85381
Actively Recruiting
3
Arizona Center for Cancer Care - Phoenix
Phoenix, Arizona, United States, 85027
Actively Recruiting
4
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, United States, 85258
Actively Recruiting
5
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, United States, 85374
Actively Recruiting
6
Arizona Center for Cancer Care
Tempe, Arizona, United States, 85284
Actively Recruiting
7
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
8
Keck Medicine of USC Buena Park
Buena Park, California, United States, 90621
Actively Recruiting
9
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
10
Los Angeles General Medical Center
Los Angeles, California, United States, 90033
Actively Recruiting
11
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
12
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Actively Recruiting
13
UC San Diego Medical Center - Hillcrest
San Diego, California, United States, 92103
Actively Recruiting
14
Shaw Cancer Center
Edwards, Colorado, United States, 81632
Actively Recruiting
15
George Washington University Medical Center
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
16
Sarasota Memorial Hospital-Venice
North Venice, Florida, United States, 34275
Actively Recruiting
17
Moffitt Cancer Center at SouthShore
Ruskin, Florida, United States, 33570
Actively Recruiting
18
Florida Cancer Specialists - Sarasota
Sarasota, Florida, United States, 34232
Actively Recruiting
19
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States, 34236
Actively Recruiting
20
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
21
Sarasota Memorial Health Care Center at University Parkway
Sarasota, Florida, United States, 34243
Actively Recruiting
22
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States, 33607
Actively Recruiting
23
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States, 33612
Actively Recruiting
24
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
25
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, United States, 34275
Actively Recruiting
26
Moffitt Cancer Center at Wesley Chapel
Wesley Chapel, Florida, United States, 33544
Actively Recruiting
27
OSF Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Actively Recruiting
28
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61704
Actively Recruiting
29
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Actively Recruiting
30
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
31
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
32
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States, 60115
Actively Recruiting
33
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
34
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Actively Recruiting
35
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States, 61401
Actively Recruiting
36
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States, 60134
Actively Recruiting
37
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
Actively Recruiting
38
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Actively Recruiting
39
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
40
Northwestern Medicine Orland Park
Orland Park, Illinois, United States, 60462
Actively Recruiting
41
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Actively Recruiting
42
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Actively Recruiting
43
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Actively Recruiting
44
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
45
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Actively Recruiting
46
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Actively Recruiting
47
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
48
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States, 60555
Actively Recruiting
49
Illinois CancerCare - Washington
Washington, Illinois, United States, 61571
Actively Recruiting
50
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Actively Recruiting
51
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
52
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
53
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Actively Recruiting
54
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
55
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
56
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
57
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
58
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
59
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Actively Recruiting
60
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
61
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
62
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
63
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
64
Baptist Health Hardin
Elizabethtown, Kentucky, United States, 42701
Actively Recruiting
65
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Actively Recruiting
66
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
67
McLaren Cancer Institute-Bay City
Bay City, Michigan, United States, 48706
Actively Recruiting
68
McLaren Cancer Institute-Clarkston
Clarkston, Michigan, United States, 48346
Actively Recruiting
69
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
70
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
71
McLaren Cancer Institute-Flint
Flint, Michigan, United States, 48532
Actively Recruiting
72
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
73
McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan, United States, 48446
Actively Recruiting
74
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States, 48043
Actively Recruiting
75
McLaren Cancer Institute-Central Michigan
Mount Pleasant, Michigan, United States, 48858
Actively Recruiting
76
McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan, United States, 49770
Actively Recruiting
77
McLaren-Port Huron
Port Huron, Michigan, United States, 48060
Actively Recruiting
78
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Actively Recruiting
79
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, United States, 39705
Actively Recruiting
80
Baptist Cancer Center-Grenada
Grenada, Mississippi, United States, 38901
Actively Recruiting
81
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, United States, 38652
Actively Recruiting
82
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States, 38655
Actively Recruiting
83
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States, 38671
Actively Recruiting
84
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Actively Recruiting
85
Lake Regional Hospital
Osage Beach, Missouri, United States, 65065
Actively Recruiting
86
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
87
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
88
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
89
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
90
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
91
Atrium Health Stanly/LCI-Albemarle
Albemarle, North Carolina, United States, 28002
Actively Recruiting
92
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
93
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, United States, 28210
Actively Recruiting
94
Atrium Health University City/LCI-University
Charlotte, North Carolina, United States, 28262
Actively Recruiting
95
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States, 28025
Actively Recruiting
96
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
97
CaroMont Regional Medical Center
Gastonia, North Carolina, United States, 28054
Actively Recruiting
98
Levine Cancer Institute-Gaston
Gastonia, North Carolina, United States, 28054
Actively Recruiting
99
Hayworth Cancer Center
High Point, North Carolina, United States, 27262
Actively Recruiting
100
Atrium Health Union/LCI-Union
Monroe, North Carolina, United States, 28112
Actively Recruiting
101
Atrium Health Cleveland/LCI-Cleveland
Shelby, North Carolina, United States, 28150
Actively Recruiting
102
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
103
Summa Health System - Akron Campus
Akron, Ohio, United States, 44304
Actively Recruiting
104
Aultman Health Foundation
Canton, Ohio, United States, 44710
Actively Recruiting
105
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
106
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
107
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
108
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
109
Chambersburg Hospital
Chambersburg, Pennsylvania, United States, 17201
Actively Recruiting
110
Ephrata Cancer Center
Ephrata, Pennsylvania, United States, 17522
Actively Recruiting
111
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
112
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, United States, 16121
Actively Recruiting
113
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Actively Recruiting
114
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States, 17109
Actively Recruiting
115
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Actively Recruiting
116
Sechler Family Cancer Center
Lebanon, Pennsylvania, United States, 17042
Actively Recruiting
117
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
118
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
119
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
120
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, United States, 16105
Actively Recruiting
121
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
Actively Recruiting
122
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
123
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
124
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
125
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
Actively Recruiting
126
WellSpan Health-York Cancer Center
York, Pennsylvania, United States, 17403
Actively Recruiting
127
Lancaster Radiation Therapy Center
Lancaster, South Carolina, United States, 29720
Actively Recruiting
128
Rock Hill Radiation Therapy Center
Rock Hill, South Carolina, United States, 29730
Actively Recruiting
129
Levine Cancer Institute-Rock Hill
Rock Hill, South Carolina, United States, 29732
Actively Recruiting
130
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States, 38017
Actively Recruiting
131
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
Actively Recruiting
132
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States, 38120
Actively Recruiting
133
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
Actively Recruiting
134
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
135
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
136
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Actively Recruiting
137
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, United States, 54806
Actively Recruiting
138
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, United States, 53051
Actively Recruiting
139
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
140
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, United States, 53295
Actively Recruiting
141
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Actively Recruiting
142
Drexel Town Square Health Center
Oak Creek, Wisconsin, United States, 53154
Actively Recruiting
143
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Actively Recruiting
144
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Actively Recruiting
145
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States, 54481
Actively Recruiting
146
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
147
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Actively Recruiting
148
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, United States, 53095
Actively Recruiting
149
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States, 54494
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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