# A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients

> **NIH NIH R01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2020 · $395,140

## Abstract

PROJECT SUMMARY
Dyspnea is one of the most common and distressing symptoms associated with cancer, occurring in nearly 70%
of patients with advanced cancer and intrathoracic malignancies. Dyspnea is associated with impaired function,
decreased quality of life, and shortened survival. Current therapies for dyspnea, such as supplemental oxygen
and opioids, provide limited relief. Although dyspnea is more difficult to treat than pain is, few clinical trials of
therapies for dyspnea have been conducted, and such trials are urgently needed to improve quality of life in
cancer patients suffering from this condition. The long-term goal of our research is to develop evidence-based
palliative therapies for dyspnea in patients with cancer.
 Corticosteroids may potentially improve the sensation of dyspnea by modulating the inflammatory
response centrally and peripherally and decreasing swelling. On the basis of our preliminary data from a recent
clinical trial, we hypothesize that high-dose dexamethasone is effective in treating cancer-related dyspnea. The
overall objective of the proposed two-arm, double-blind, parallel (2:1), randomized, controlled trial is to compare
the effect of dexamethasone with that of placebo on cancer-related dyspnea. The primary specific aim of this
study is to compare the intensity of dyspnea in the dexamethasone arm with that in the placebo arm at week 1.
In the second specific aim, we will compare the effects of dexamethasone with those of placebo in terms of
personalized dyspnea response (based on a personalized dyspnea goal), unpleasantness of dyspnea, other
symptoms, health-related quality of life, respiratory physiologic function, and adverse effects at week 1 and week
2, as well as the intensity of dyspnea at week 2. The third aim is to identify predictive markers of dyspnea
response to dexamethasone. After obtaining surrogate consent, we will randomize patients to receive either
dexamethasone or placebo twice daily for 2 weeks and monitor the patients closely.
 The proposed study is innovative in that it will cover a novel set of indications (i.e., both intensity and
unpleasantness of dyspnea), patient population (i.e., patients with cancer), predictive makers (i.e., inflammatory
biomarkers, respiratory physiologic function), and patient-reported outcome measures (i.e., personalized
dyspnea response, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events
instrument) for dexamethasone. The expected outcome of the proposed study is to establish dexamethasone as
a treatment for dyspnea in patients with cancer. These results are expected to have an important positive clinical
effect because the effective management of dyspnea will help improve patients' quality of life. This study will
also increase our fundamental understanding of the pathophysiology of dyspnea, such as how dexamethasone
improves inflammation and respiratory physiologic parameters, which may allow us to devise new and more
e...

## Key facts

- **NIH application ID:** 9994852
- **Project number:** 5R01CA214960-04
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** David Hui
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $395,140
- **Award type:** 5
- **Project period:** 2017-09-21 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994852

## Citation

> US National Institutes of Health, RePORTER application 9994852, A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients (5R01CA214960-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9994852. Licensed CC0.

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