# A Combination Therapy to Treat Cancer-Related Fatigue

> **NIH NIH R01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2022 · $475,796

## Abstract

PROJECT SUMMARY
Cancer-related fatigue (CRF) is the most frequent and debilitating symptom experienced by prostate cancer
patients during and after curative treatment-radiotherapy (RT) and androgen deprivation therapy (ADT), and
has detrimental effects on patients' physical, psychological, social, occupational functioning and overall quality
of life; however, current treatment options fail to satisfactorily alleviate CRF. Exercise (EX) and
Methylphenidate (MP) are by far the most investigated and beneficial therapies for CRF, but both have only
modest effects. Based on preliminary data suggesting that the combination of EX plus MP is feasible and may
be efficacious in reducing CRF, the proposed research will address the guiding hypothesis that combining EX
plus MP will result in a more robust improvement of fatigue using a randomized placebo-controlled trial. The
primary objective is to determine if the combination of EX + MP is superior to EX plus placebo in the treatment
of CRF in patients with prostate cancer scheduled to receive radiotherapy with androgen deprivation therapy
for 12 weeks (Aim 1). CRF will be measured using the area under the curve (AUC) in the Functional
Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale to test the hypothesis that the combination
of EX plus MP will result in a greater reduction of CRF compared with exercise plus placebo. To address the
hypothesis that the combination of EX plus MP will result in improvements in additional CRF-related measures,
the effects of EX plus MP on quality-of-life (using the Functional Assessment of Cancer Therapy – General),
sleep disturbance (using the Pittsburgh Sleep Quality Index and the Multidimensional Fatigue Symptom
Inventory), sleep/wake time activity (actigraphy), anxiety and depressed mood (using the Hospital Anxiety and
Depression Scale), physical function (using usual gait speed, the 30-second chair stand test, and hand grip
strength), cardiorespiratory fitness (VO2 max), inflammation (C-reactive protein), and cognitive measures will
be assessed (Aim 2). To address the hypothesis that the combination of methylphenidate plus exercise will
have synergistic effects that exceed the reduction in CRF by either exercise alone or methylphenidate alone,
potential synergistic effects of EX and MP will be evaluated by measuring the FACIT-F AUC in all four arms,
thus informing a model of how EX and MP may interact together (Aim 3). Finally, differences in brain activity
between responders and non-responders to the EX plus MP intervention will be explored using
electroencephalography (EEG) (Aim 4) in order to identify novel biomarkers of CRF and to inform a new model
integrating underlying CRF and its dimensions in response to EX and/or MP. The innovative use of existing
technologies, combined with a novel approach to CRF targeting a specific and well-defined patient population,
could provide evidence for a safe, feasible, and effective treatment for CRF, and will yield...

## Key facts

- **NIH application ID:** 10308673
- **Project number:** 5R01CA231521-04
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** Sriram Yennu
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $475,796
- **Award type:** 5
- **Project period:** 2018-12-01 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10308673

## Citation

> US National Institutes of Health, RePORTER application 10308673, A Combination Therapy to Treat Cancer-Related Fatigue (5R01CA231521-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10308673. Licensed CC0.

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