Exercise +/− Dexamethasone for Cancer Fatigue

Overseen by Sriram Yennu

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II/III trial studies how well physical activity with or without dexamethasone works in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body or has come back. Dexamethasone may decrease the body's immune response. Combining physical activity with dexamethasone may help to treat fatigue in patients with cancer.

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with advanced or recurrent cancer experiencing fatigue. They must have normal cognition, a hemoglobin level above 8 g/L, be able to perform daily activities with minimal assistance (Zubrod status ≤2), speak English, and have a life expectancy of at least 4 months. They can't join if they're allergic to dexamethasone, recently fell, have severe infections or neutropenia, uncontrolled diabetes, heart disease, active ulcers or are already very physically active.

Inclusion Criteria

My advanced cancer causes me significant fatigue.

I have been feeling tired for at least two weeks.

Hemoglobin > 8 g/L within 2 weeks of enrollment in the study

Exclusion Criteria

I have severe heart problems that limit my daily activities.

I am allergic to dexamethasone or my doctor says I shouldn't exercise.

My diabetes is not under control, with blood sugar often over 200 mg/dl.

Treatment Details

Interventions

• Dexamethasone (Corticosteroid)
• Exercise Intervention (Behavioural Intervention)

Trial Overview The study is testing whether exercise alone or combined with the drug dexamethasone reduces fatigue in patients with advanced cancer. Participants will either engage in physical activity only or take dexamethasone alongside exercising. Some may receive a placebo instead of the actual drug.

Participant Groups

Group I: Arm I (dexamethasone, exercise) Experimental Treatment 2 Interventions

Patients receive dexamethasone PO BID for 7 days. Patients also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.

Group II: Arm II (placebo, exercise) Active Control 2 Interventions

Patients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School