Physical Activity With or Without Dexamethasone in Reducing Cancer-Related Fatigue in Participants With Advanced, Metastatic, or Recurrent Cancer

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn about the effects of combining physical activity with dexamethasone to treat fatigue in patients with advanced cancer.

In this study, dexamethasone will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

This is an investigational study. Dexamethasone is FDA approved and commercially available for the treatment of loss of appetite, tiredness, pain, and nausea. It is investigational to combine dexamethasone and exercise to treat fatigue in advanced cancer patients. The study doctor can explain how the study drug is designed to work.

Up to 70 participants will be enrolled in this study. All will take part at MD Anderson.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institute of Nursing Research (NINR)
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Ichthammol

Criteria

Inclusion Criteria:

1. Diagnosis of advanced cancer (defined as metastatic or recurrent incurable cancer) with fatigue >/= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)

2. Presence of fatigue for at least 2 weeks

3. Normal cognition defined as Memorial Delirium Assessment Scale (MDAS) of

4. Hemoglobin >10 g/L within 1 week of enrollment in the study

5. Zubrod performance status

6. Life expectancy of >/= 4 months

7. Able to read, write, and speak English.

Exclusion Criteria:

1. Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician

2. Reports of a fall in the past 30 days

3. Diabetes mellitus, sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials

4. Current, active peptic ulcer disease

5. Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm

6. Regular participation in moderate- or vigorous-intensity physical activity for >/= 30 minutes at least 5 times a week and strength training for >/= 2 days

7. Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease

8. Patients currently on immunotherapy

9. Inability to comply with study protocol procedures