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Investigating the Impact of Biological Sex on the Pathophysiology of Radiation-Induced Oral Mucositis

Award Number: R21DE036324
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/09/2026
PERIOD OF PERFORMANCE END DATE: 07/08/2028

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Investigating the Impact of Biological Sex on the Pathophysiology of Radiation-Induced Oral Mucositis - Project Summary Oral mucositis (OM) is a painful, dose-limiting toxicity of head and neck cancer radiotherapy, affecting more than 80% of patients and nearly all receiving fractionated regimens. OM causes severe ulcerations, malnutrition, treatment interruptions, and diminished quality of life, yet there are no effective targeted therapies. Clinical and preclinical evidence indicate that sex is a biological variable influencing OM severity, with female patients experiencing greater ulceration, heightened pain, and slower recovery than male patients. However, the molecular and cellular mechanisms underlying these sex differences remain unknown. The long-term objective of this project is to advance precision supportive oncology by defining sex-specific pathways that drive radiation- induced OM. The central hypothesis is that sex-dependent transcriptional programs regulate epithelial injury, immune infiltration, and extracellular matrix (ECM) remodeling, resulting in differential severity and healing in males and females. To test this hypothesis, two complementary aims are proposed: (1) use single-cell RNA sequencing (scRNA-seq) and spatial transcriptomics to define sex-specific transcriptional programs in irradiated oral mucosa; and (2) use multimodal spectral flow cytometry and multiplex immunofluorescence to characterize immune infiltration and ECM remodeling in OM lesions in a sex-dependent manner. The proposed studies will integrate transcriptional, cellular, and tissue-level data to generate the first sex-specific molecular and cellular atlas of OM. This high-risk, high-reward project will establish sex as a mechanistic determinant of OM pathogenesis, identify new therapeutic targets, and provide a framework for sex-specific, precision-based interventions. The impact of this work will be to establish sex as a mechanistic determinant of OM pathogenesis, enabling new precision-based therapeutic approaches that improve management of OM, enhance treatment adherence, and lead to better outcomes for cancer patients undergoing radiotherapy.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $440,275 )
2026	2026	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	520 LEE ENTRANCE STE 211	AMHERST	NY	14228	ERIE	USA	Oral Diseases and Disorders Research	000	1	7/13/2026	NEW	$440,275
														Subtotal = $440,275

Grand Total All Awards = $440,275

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Investigating the Impact of Biological Sex on the Pathophysiology of Radiation-Induced Oral Mucositis

Award Number: R21DE036324

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/09/2026

PERIOD OF PERFORMANCE END DATE: 07/08/2028

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