# Radiation-Induced Fibrosis and Co-occurring Adverse Treatment-Related Effects in Head and Neck Cancer Survivors

> **NIH NIH R37** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $598,497

## Abstract

PROJECT SUMMARY. The intensity of standard treatments (i.e., chemoradiation) for head and neck cancer
(HNC) has amplified over the last two decades, resulting in a 500% increase in acute toxicities. These
demanding regimens leave 90% of HNC survivors with adverse treatment effects. For some, radiation-induced
fibrosis (RIF) is progressive, leading to debilitating treatment-related effects. The most serious sequelae are
neck disability and dysphagia, which reduces QOL and survival. Our research team has empirically described
the burden and impact of neck disability and impairment in HNC survivors. Results showed that 54% of HNC
survivors reported neck disability and that increasing neck disability was associated with worsening dysphagia
symptoms. However, we know very little about the characterization of RIF and its co-occurring adverse
treatment effects trajectories (i.e., patterns of change over time), thus prohibiting the development of tailored
interventions to mitigate morbidity. Also, while reliable biomarkers to determine those at greatest risk for RIF do
not exist, our preliminary work indicates that specific circulating microRNAs (miRNAs) may be associated with
late RIF. There is a critical need to appreciate the clinical trajectories of RIF and subsequent adverse effects
and elucidate the factors underlying the development and variability in these trajectories to optimize HNC
survivors’ well-being. The purpose of this study is to determine the distinct trajectories of RIF and co-occurring
adverse treatment effects (i.e., neck disability, dysphagia) and the factors that impact those trajectories. Our
central hypothesis is that 1) substantial variability in RIF and co-occurring adverse treatment effects exist in
HNC patients receiving radiation, 2) this variability will cluster into distinct trajectories, and 3) group
membership will be explained by individual factors, cancer/cancer treatment characteristics, and miRNA
variations. This prospective study (n=334) uses a longitudinal design with assessments at pre-radiation (Time
0) and follow-up at 1 (Time 1), 6 (Time 2), 12 (Time 3), and 24 months (Time 4, exploratory) post-radiation.
Aim 1 is to characterize the trajectories of RIF and co-occurring adverse treatment effects (i.e., neck disability,
dysphagia) and their associations. In Aim 2, we will determine the individual and cancer/treatment factors that
explain variability in RIF and the co-occurring adverse treatment effects. Aim 3 will explore the trajectories of
RIF and co-occurring adverse treatment effects through 24 months post-radiation. Finally, Aim 4 will explore
circulating miRNAs associated with trajectories of RIF and co-occurring adverse treatment effects. Group-
based and dual trajectory modeling and multinomial logistic regression with model validation will be employed.
This study is essential to develop interventions to mitigate RIF and subsequent co-occurring treatment effects
HNC survivors experience to reduce morbidi...

## Key facts

- **NIH application ID:** 10844419
- **Project number:** 5R37CA279210-02
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** MARCI LEE NILSEN
- **Activity code:** R37 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $598,497
- **Award type:** 5
- **Project period:** 2023-07-01 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10844419

## Citation

> US National Institutes of Health, RePORTER application 10844419, Radiation-Induced Fibrosis and Co-occurring Adverse Treatment-Related Effects in Head and Neck Cancer Survivors (5R37CA279210-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10844419. Licensed CC0.

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