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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    70
  • sponsor
    M.D. Anderson Cancer Center
Updated on 9 March 2022
cancer
delirium
advanced cancer

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.

Details
Condition Advanced Malignant Neoplasm, Cancer Fatigue, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
Treatment Placebo, Dexamethasone, exercise intervention
Clinical Study IdentifierNCT03583255
SponsorM.D. Anderson Cancer Center
Last Modified on9 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
Presence of fatigue for at least 2 weeks
Normal cognition defined as Memorial Delirium Assessment Scale (MDAS) of </= 13/30
Hemoglobin >10 g/L within 1 week of enrollment in the study
Zubrod performance status </= 2
Life expectancy of >/= 4 months
Able to read, write, and speak English

Exclusion Criteria

Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician
Reports of a fall in the past 30 days
Diabetes mellitus, sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
Current, active peptic ulcer disease
Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm
Regular participation in moderate- or vigorous-intensity physical activity for >/= 30 minutes at least 5 times a week and strength training for >/= 2 days
Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
Patients currently on immunotherapy
Inability to comply with study protocol procedures
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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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