Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer

Summary

This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.

Timeline

Start

2015-08-13

Primary completion

2019-03-28

Completion

2026-12-31

Outcome

Met primary endpoint

paper Mixed-model analysis showed a significant improvement in the FACIT-F scores at day 8 (P<.001), day 15 (P<.001), and day 29 (P=.002). PMID 34965510 ↗

paper The FACIT-F effect size in the LoDex arm was 0.90 (P<.001) and 0.92 (P<.001) and the effect size in the HiDex arm was 0.86 and 1.03 (P<.001 for both) at days 8 and 29, respectively. PMID 34965510 ↗

Publications

• Yennurajalingam S, Valero V, Lu Z, Liu DD, Busaidy NL, Reuben JM, Diaz Fleming C, Williams JL, Hess KR, Basen-Engquist K, Bruera E. Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial. J Natl Compr Canc Netw. 2021 Dec 29;20(3):235-243. doi: 10.6004/jnccn.2021.7066.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	4 mg	Oral
Subject	Dexamethasone	Small molecule	8 mg	Oral

Indications