New drug aims to ease painful mouth sores for head and neck cancer patients

NCT ID NCT06532279

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase II trial tests whether adding BMX-001 to standard symptom management can reduce severe mouth sores in head and neck cancer patients receiving chemoradiation. About 98 participants will receive either BMX-001 or a placebo alongside usual care. The goal is to see if BMX-001 helps prevent painful inflammation and swallowing problems caused by treatment.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
BMX-001
What this could lead to
If it works, this could provide a new way to reduce painful mouth sores during chemoradiation, improving quality of life for head and neck cancer patients.
What could go wrong
This is a mid-stage trial with only 98 participants, so results may not apply to everyone. BMX-001 is still experimental, and its benefits over standard care are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CLINICAL STAGE I HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 CLINICAL STAGE II HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 CLINICAL STAGE III HPV-MEDIATED (P16-POSITIVE) OROPHARYNGEAL CARCINOMA AJCC V8 HEAD AND NECK SQUAMOUS CELL CARCINOMA HYPOPHARYNGEAL SQUAMOUS CELL CARCINOMA LARYNGEAL SQUAMOUS CELL CARCINOMA NASOPHARYNGEAL SQUAMOUS CELL CARCINOMA ORAL CAVITY SQUAMOUS CELL CARCINOMA OROPHARYNGEAL SQUAMOUS CELL CARCINOMA STAGE 0 CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AJCC V8 STAGE 0 HEAD AND NECK CUTANEOUS SQUAMOUS CELL CARCINOMA AJCC V8 STAGE 0 HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE 0 NASOPHARYNGEAL CARCINOMA AJCC V8 STAGE 0 OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STAGE I CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AJCC V8 STAGE I HEAD AND NECK CUTANEOUS SQUAMOUS CELL CARCINOMA AJCC V8 STAGE I HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE I LARYNGEAL CANCER AJCC V8 STAGE I LIP AND ORAL CAVITY CANCER AJCC V8 STAGE I NASOPHARYNGEAL CARCINOMA AJCC V8 STAGE I OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STAGE II CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AJCC V8 STAGE II HEAD AND NECK CUTANEOUS SQUAMOUS CELL CARCINOMA AJCC V8 STAGE II HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE II LARYNGEAL CANCER AJCC V8 STAGE II LIP AND ORAL CAVITY CANCER AJCC V8 STAGE II NASOPHARYNGEAL CARCINOMA AJCC V8 STAGE II OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STAGE III CUTANEOUS SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK AJCC V8 STAGE III HEAD AND NECK CUTANEOUS SQUAMOUS CELL CARCINOMA AJCC V8 STAGE III HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE III LARYNGEAL CANCER AJCC V8 STAGE III LIP AND ORAL CAVITY CANCER AJCC V8 STAGE III NASOPHARYNGEAL CARCINOMA AJCC V8 STAGE III OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STAGE IVA HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVA LARYNGEAL CANCER AJCC V8 STAGE IVA LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVA NASOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVA OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STAGE IVB HYPOPHARYNGEAL CARCINOMA AJCC V8 STAGE IVB LARYNGEAL CANCER AJCC V8 STAGE IVB LIP AND ORAL CAVITY CANCER AJCC V8 STAGE IVB OROPHARYNGEAL (P16-NEGATIVE) CARCINOMA AJCC V8 STOMATITIS

Contacts and locations

Locations

  • Adams Cancer Center

    RECRUITING

    Gettysburg, Pennsylvania, 17325, United States

  • Arizona Center for Cancer Care

    RECRUITING

    Tempe, Arizona, 85284, United States

  • Arizona Center for Cancer Care - Gilbert

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Arizona Center for Cancer Care - Phoenix

    RECRUITING

    Phoenix, Arizona, 85027, United States

  • Arizona Center for Cancer Care - Scottsdale

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Arizona Center for Cancer Care-Peoria

    RECRUITING

    Peoria, Arizona, 85381, United States

  • Arizona Center for Cancer Care-Surprise

    RECRUITING

    Surprise, Arizona, 85374, United States

  • Aspirus Cancer Care - James Beck Cancer Center

    RECRUITING

    Rhinelander, Wisconsin, 54501, United States

  • Aspirus Cancer Care - Stevens Point

    RECRUITING

    Stevens Point, Wisconsin, 54481, United States

  • Aspirus Cancer Care - Wisconsin Rapids

    RECRUITING

    Wisconsin Rapids, Wisconsin, 54494, United States

  • Aspirus Regional Cancer Center

    RECRUITING

    Wausau, Wisconsin, 54401, United States

  • Atrium Health Cabarrus/LCI-Concord

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Atrium Health Cleveland/LCI-Cleveland

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Atrium Health Pineville/LCI-Pineville

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Atrium Health Stanly/LCI-Albemarle

    RECRUITING

    Albemarle, North Carolina, 28002, United States

  • Atrium Health Union/LCI-Union

    RECRUITING

    Monroe, North Carolina, 28112, United States

  • Atrium Health University City/LCI-University

    RECRUITING

    Charlotte, North Carolina, 28262, United States

  • Aultman Health Foundation

    RECRUITING

    Canton, Ohio, 44710, United States

    Contact Email: •••••@•••••

  • Baptist Cancer Center-Grenada

    RECRUITING

    Grenada, Mississippi, 38901, United States

    Contact Email: •••••@•••••

  • Baptist Health Floyd

    RECRUITING

    New Albany, Indiana, 47150, United States

  • Baptist Health Hardin

    RECRUITING

    Elizabethtown, Kentucky, 42701, United States

  • Baptist Memorial Hospital and Cancer Center-Collierville

    RECRUITING

    Collierville, Tennessee, 38017, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Desoto

    RECRUITING

    Southhaven, Mississippi, 38671, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Golden Triangle

    RECRUITING

    Columbus, Mississippi, 39705, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Memphis

    RECRUITING

    Memphis, Tennessee, 38120, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Oxford

    RECRUITING

    Oxford, Mississippi, 38655, United States

    Contact Email: •••••@•••••

  • Baptist Memorial Hospital and Cancer Center-Union County

    RECRUITING

    New Albany, Mississippi, 38652, United States

    Contact Email: •••••@•••••

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Carle Cancer Center

    RECRUITING

    Urbana, Illinois, 61801, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Effingham

    RECRUITING

    Effingham, Illinois, 62401, United States

    Contact Email: •••••@•••••

  • Carle Physician Group-Mattoon/Charleston

    RECRUITING

    Mattoon, Illinois, 61938, United States

    Contact Email: •••••@•••••

  • Carle at The Riverfront

    RECRUITING

    Danville, Illinois, 61832, United States

    Contact Email: •••••@•••••

  • CaroMont Regional Medical Center

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Chambersburg Hospital

    RECRUITING

    Chambersburg, Pennsylvania, 17201, United States

  • Dartmouth Cancer Center - North

    RECRUITING

    Saint Johnsbury, Vermont, 05819, United States

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Drexel Town Square Health Center

    RECRUITING

    Oak Creek, Wisconsin, 53154, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Ephrata Cancer Center

    RECRUITING

    Ephrata, Pennsylvania, 17522, United States

  • Florida Cancer Specialists - Sarasota

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Florida Cancer Specialists - Sarasota Downtown

    RECRUITING

    Sarasota, Florida, 34239, United States

    Contact Email: •••••@•••••

  • Florida Cancer Specialists - Venice Pinebrook

    RECRUITING

    Venice, Florida, 34275, United States

    Contact Email: •••••@•••••

  • Froedtert Menomonee Falls Hospital

    RECRUITING

    Menomonee Falls, Wisconsin, 53051, United States

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    RECRUITING

    West Bend, Wisconsin, 53095, United States

  • George Washington University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • Greater Baltimore Medical Center

    RECRUITING

    Baltimore, Maryland, 21204, United States

  • Hayworth Cancer Center

    RECRUITING

    High Point, North Carolina, 27262, United States

  • Illinois CancerCare - Washington

    RECRUITING

    Washington, Illinois, 61571, United States

  • Illinois CancerCare-Bloomington

    RECRUITING

    Bloomington, Illinois, 61704, United States

  • Illinois CancerCare-Canton

    RECRUITING

    Canton, Illinois, 61520, United States

  • Illinois CancerCare-Eureka

    RECRUITING

    Eureka, Illinois, 61530, United States

  • Illinois CancerCare-Galesburg

    RECRUITING

    Galesburg, Illinois, 61401, United States

  • Illinois CancerCare-Kewanee Clinic

    RECRUITING

    Kewanee, Illinois, 61443, United States

  • Illinois CancerCare-Macomb

    RECRUITING

    Macomb, Illinois, 61455, United States

  • Illinois CancerCare-Ottawa Clinic

    RECRUITING

    Ottawa, Illinois, 61350, United States

  • Illinois CancerCare-Pekin

    RECRUITING

    Pekin, Illinois, 61554, United States

  • Illinois CancerCare-Peoria

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Illinois CancerCare-Peru

    RECRUITING

    Peru, Illinois, 61354, United States

  • Illinois CancerCare-Princeton

    RECRUITING

    Princeton, Illinois, 61356, United States

  • Iowa Methodist Medical Center

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • Karmanos Cancer Institute at McLaren Greater Lansing

    RECRUITING

    Lansing, Michigan, 48910, United States

    Contact Email: •••••@•••••

  • Keck Medicine of USC Buena Park

    SUSPENDED

    Buena Park, California, 90621, United States

  • Lake Regional Hospital

    RECRUITING

    Osage Beach, Missouri, 65065, United States

    Contact Email: •••••@•••••

  • Lancaster Radiation Therapy Center

    RECRUITING

    Lancaster, South Carolina, 29720, United States

  • Langlade Hospital and Cancer Center

    RECRUITING

    Antigo, Wisconsin, 54409, United States

  • Levine Cancer Institute-Gaston

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • Levine Cancer Institute-Rock Hill

    RECRUITING

    Rock Hill, South Carolina, 29732, United States

  • Los Angeles General Medical Center

    SUSPENDED

    Los Angeles, California, 90033, United States

  • McFarland Clinic - Ames

    RECRUITING

    Ames, Iowa, 50010, United States

  • McLaren Cancer Institute-Bay City

    RECRUITING

    Bay City, Michigan, 48706, United States

    Contact Email: •••••@•••••

  • McLaren Cancer Institute-Central Michigan

    RECRUITING

    Mount Pleasant, Michigan, 48858, United States

    Contact Email: •••••@•••••

  • McLaren Cancer Institute-Clarkston

    RECRUITING

    Clarkston, Michigan, 48346, United States

    Contact Email: •••••@•••••

  • McLaren Cancer Institute-Flint

    RECRUITING

    Flint, Michigan, 48532, United States

    Contact Email: •••••@•••••

  • McLaren Cancer Institute-Lapeer Region

    RECRUITING

    Lapeer, Michigan, 48446, United States

    Contact Email: •••••@•••••

  • McLaren Cancer Institute-Macomb

    RECRUITING

    Mount Clemens, Michigan, 48043, United States

    Contact Email: •••••@•••••

  • McLaren Cancer Institute-Northern Michigan

    RECRUITING

    Petoskey, Michigan, 49770, United States

    Contact Email: •••••@•••••

  • McLaren-Port Huron

    RECRUITING

    Port Huron, Michigan, 48060, United States

    Contact Email: •••••@•••••

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Mercy Hospital

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Mercy Medical Center - Des Moines

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • Miller-Dwan Hospital

    RECRUITING

    Duluth, Minnesota, 55805, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center - McKinley Campus

    RECRUITING

    Tampa, Florida, 33612, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center at SouthShore

    RECRUITING

    Ruskin, Florida, 33570, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center at Wesley Chapel

    RECRUITING

    Wesley Chapel, Florida, 33544, United States

    Contact Email: •••••@•••••

  • Moffitt Cancer Center-International Plaza

    RECRUITING

    Tampa, Florida, 33607, United States

    Contact Email: •••••@•••••

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Einstein Campus

    RECRUITING

    The Bronx, New York, 10461, United States

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    RECRUITING

    Jonesboro, Arkansas, 72401, United States

  • Northwest Wisconsin Cancer Center

    RECRUITING

    Ashland, Wisconsin, 54806, United States

    Contact Email: •••••@•••••

  • Northwestern Medicine Cancer Center Delnor

    RECRUITING

    Geneva, Illinois, 60134, United States

  • Northwestern Medicine Cancer Center Kishwaukee

    RECRUITING

    DeKalb, Illinois, 60115, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern Medicine Oak Brook

    RECRUITING

    Oak Brook, Illinois, 60523, United States

  • Northwestern Medicine Orland Park

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • OSF Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • OSF Saint Joseph Medical Center

    RECRUITING

    Bloomington, Illinois, 61701, United States

  • Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oncology Associates at Mercy Medical Center

    RECRUITING

    Cedar Rapids, Iowa, 52403, United States

  • Penn State Milton S Hershey Medical Center

    RECRUITING

    Hershey, Pennsylvania, 17033-0850, United States

  • ProHealth D N Greenwald Center

    ACTIVE_NOT_RECRUITING

    Mukwonago, Wisconsin, 53149, United States

  • ProHealth Oconomowoc Memorial Hospital

    ACTIVE_NOT_RECRUITING

    Oconomowoc, Wisconsin, 53066, United States

  • Renown Regional Medical Center

    RECRUITING

    Reno, Nevada, 89502, United States

    Contact Email: •••••@•••••

  • Rock Hill Radiation Therapy Center

    RECRUITING

    Rock Hill, South Carolina, 29730, United States

  • Saint Francis Medical Center

    RECRUITING

    Cape Girardeau, Missouri, 63703, United States

  • Salina Regional Health Center

    RECRUITING

    Salina, Kansas, 67401, United States

  • Sarasota Memorial Health Care Center at University Parkway

    RECRUITING

    Sarasota, Florida, 34243, United States

  • Sarasota Memorial Hospital

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Sarasota Memorial Hospital-Venice

    RECRUITING

    N. Venice, Florida, 34275, United States

  • Sechler Family Cancer Center

    RECRUITING

    Lebanon, Pennsylvania, 17042, United States

  • Shaw Cancer Center

    RECRUITING

    Edwards, Colorado, 81632, United States

  • Summa Health System - Akron Campus

    RECRUITING

    Akron, Ohio, 44304, United States

    Contact Email: •••••@•••••

  • UC San Diego Health System - Encinitas

    RECRUITING

    Encinitas, California, 92024, United States

  • UC San Diego Medical Center - Hillcrest

    RECRUITING

    San Diego, California, 92103, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

    Contact Email: •••••@•••••

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    RECRUITING

    Ankeny, Iowa, 50023, United States

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    RECRUITING

    Des Moines, Iowa, 50309, United States

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    RECRUITING

    Des Moines, Iowa, 50314, United States

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    RECRUITING

    Waukee, Iowa, 50263, United States

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    RECRUITING

    Clive, Iowa, 50325, United States

  • UPMC Cancer Center - Monroeville

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

  • UPMC Cancer Center at UPMC Horizon

    RECRUITING

    Farrell, Pennsylvania, 16121, United States

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    RECRUITING

    Greensburg, Pennsylvania, 15601, United States

  • UPMC Hillman Cancer Center - Monroeville

    RECRUITING

    Monroeville, Pennsylvania, 15146, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center - New Castle

    RECRUITING

    New Castle, Pennsylvania, 16105, United States

  • UPMC Hillman Cancer Center Erie

    RECRUITING

    Erie, Pennsylvania, 16505, United States

    Contact Email: •••••@•••••

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    RECRUITING

    Mechanicsburg, Pennsylvania, 17050, United States

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    RECRUITING

    Harrisburg, Pennsylvania, 17109, United States

  • UPMC-Passavant Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15237, United States

  • UPMC-Saint Clair Hospital Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15243, United States

  • UPMC-Saint Margaret

    RECRUITING

    Pittsburgh, Pennsylvania, 15215, United States

  • UPMC-Shadyside Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USC / Norris Comprehensive Cancer Center

    SUSPENDED

    Los Angeles, California, 90033, United States

  • USC Norris Oncology/Hematology-Newport Beach

    SUSPENDED

    Newport Beach, California, 92663, United States

  • UW Cancer Center at ProHealth Care

    ACTIVE_NOT_RECRUITING

    Waukesha, Wisconsin, 53188, United States

  • University of Cincinnati Cancer Center-UC Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

    Contact Email: •••••@•••••

  • University of Cincinnati Cancer Center-West Chester

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

  • University of Iowa/Holden Comprehensive Cancer Center

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Cancer Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kansas Hospital-Westwood Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of New Mexico Cancer Center

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Cancer Institute (UPCI)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Tennessee - Knoxville

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • VCU Massey Cancer Center at Stony Point

    RECRUITING

    Richmond, Virginia, 23235, United States

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Wayne State University/Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

    Contact Email: •••••@•••••

  • Weisberg Cancer Treatment Center

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

    Contact Email: •••••@•••••

  • WellSpan Health-York Cancer Center

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Zablocki Veterans Administration Medical Center

    RECRUITING

    Milwaukee, Wisconsin, 53295, United States

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