Program Official

Principal Investigator

Mark Hyman
Rapaport
Awardee Organization

University Of Utah
United States

Fiscal Year
2021
Activity Code
R21
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Massage for Prostate Cancer-Related Fatigue

With over 15.5 million cancer survivors today in the United States, increased attention is being given to quality of life after cancer treatment. Cancer-related fatigue (CRF), a persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity, is the most common, and one of the most devastating symptoms among patients with cancer. CRF can persist for months or years after cancer therapy is completed. Prostate cancer (PCa) is the most prevalent cancer in men and has the highest Medicare expenditure of any cancer that affects older men. Modern tailored treatment regimens have resulted in longer life expectancy, which lead to treatment related morbidity and adverse side effects, including psychological distress, pain and CRF. This R21 will investigate the therapeutic and biological effects of Swedish Massage Therapy (SMT) for CRF in PCa and is an extension of our completed study in breast cancer survivors with CRF demonstrating that SMT produces clinically and statistically significant improvements in fatigue and quality of life (QOL). A homogenous group of PCa survivors with CRF (n=15 per group) will be randomized to one of three conditions: 6 weeks of once-weekly SMT, 6 weeks of once-weekly Light Touch (LT), or a 6 week wait list control (WLC) condition. Subjects that complete SMT or LT will be followed up for persistent changes in CRF at 6 and 12 weeks after the last study visit. We hypothesize that SMT will have a clinically meaningful benefit in improving fatigue, mood, and QOL in PCa patients, and that this will correlate with favorable changes in physiological parameters that may underlie CRF and potentially impact disease progression. Primary Aim: To conduct a preliminary study to determine whether a 6-week SMT intervention decreases CRF among PCa survivors who have received both radiation and androgen deprivation therapy. Secondary Aim: To determine whether the hypothesized decrease in CRF with SMT is associated with modulation of specific immune system factors underlying chronic inflammation. Exploratory Aims: 1) To determine whether SMT improves self-reported fatigue, QOL, depression, and anxiety significantly more than LT or WLC, as assessed (respectively) by the Patient-Reported Outcomes Measurement System (PROMIS) Fatigue Scale, the Quality of Life, Enjoyment, and Satisfaction Questionnaire – short form (Q-LES-Q), the Quick Inventory of Depressive Symptoms – Self-Report (QIDS-SR16), and the GAD-7. 2) To gather preliminary data about the sustained actions of 6 weeks of SMT versus LT on CRF, by measuring MFI and PROMIS Fatigue Scale scores at 6 weeks and 12 weeks after the intervention. This research will provide preliminary data demonstrating that SMT is an effective intervention for mitigating CRF in a group of PCa survivors, that this effect is mediated by changes in key pro- and anti-inflammatory cytokines, and that SMT improves QOL and mood symptoms.

Clinical Trials

Study Name Clinical Trial ID
Massage for Prostate Cancer-Related Fatigue, mPROSTATE Study NCT05067777