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Corticosteroid

Exercise + Dexamethasone for Cancer-Related Fatigue

Phase 2 & 3

Waitlist Available

Led By Sriram Yennu

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients must be able to understand, read, write, and speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 8, day 29

Awards & highlights

Study Summary

This trial is testing how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with advanced cancer.

Who is the study for?

This trial is for patients with advanced cancer experiencing fatigue. They must have had this fatigue for at least two weeks, a life expectancy of 4 months or more, and no severe anxiety or depression. Participants should not be highly active already, have uncontrolled diabetes, recent falls, ongoing infections treated with antimicrobials, severe heart disease, or hypersensitivity to dexamethasone.Check my eligibility

What is being tested?

The study is testing whether high dose or low dose dexamethasone combined with physical activity can reduce fatigue in patients with advanced cancer. It involves exercise interventions and assessments like lab biomarker analysis and quality-of-life questionnaires to see which combination works better.See study design

What are the potential side effects?

Dexamethasone may cause side effects such as increased blood sugar levels (especially important for diabetics), insomnia, indigestion, increased appetite leading to weight gain, mood swings and weakened immune system making one prone to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced cancer and feel very tired most of the time.

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I can understand and communicate in English or Spanish.

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My thinking and memory skills are normal.

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I have been feeling tired for at least 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 8, day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 8, day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 8, day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29

Secondary outcome measures

Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue

Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score

Fatigue

Other outcome measures

Change in Hospital Anxiety Depression Scale scores

Change in Multidimensional Fatigue Symptom Inventory-Short Form scores

Change in Patient-Reported Outcomes Measurement Information System-Fatigue scores

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (low dose dexamethasone, physical activity)Experimental Treatment5 Interventions

Patients receive low-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

Group II: Arm I (high-dose dexamethasone, physical activity)Experimental Treatment5 Interventions

Patients receive high-dose dexamethasone PO BID for 7 days. Patients also follow a graded resistance exercise program 3 days a week and a walking regimen at least 5 days a week for 4 weeks. The frequency, duration, and intensity of the exercises will be evaluated and adjusted as necessary.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

Exercise Intervention

2016

Completed Phase 4

~1330

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,231 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,662 Previous Clinical Trials

40,925,791 Total Patients Enrolled

Sriram YennuPrincipal InvestigatorM.D. Anderson Cancer Center

12 Previous Clinical Trials

1,467 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02491632 — Phase 2 & 3

Malignant Neoplasm Research Study Groups: Arm I (high-dose dexamethasone, physical activity), Arm II (low dose dexamethasone, physical activity)

Malignant Neoplasm Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT02491632 — Phase 2 & 3

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02491632 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What condition is Exercise Intervention regularly used as a cure for?

"ophthalmia, sympathetic is a condition that can be mitigated by Exercise Intervention. Other maladies that can be helped by this method include branch retinal vein occlusion, macular edema, and general eye pain."

Answered by AI

Can people sign up for this clinical trial right now?

"Unfortunately, this particular study is no longer recruiting patients. The trial was first posted on 8/13/2015 and had its last update on 8/25/2022. However, there are many other studies that may be of interest. There are presently 3595 studies actively enrolling patients with fatigue and 576 trials for Exercise Intervention actively enrolling patients."

Answered by AI

How big is the patient pool for this research project?

"Unfortunately, this study has completed recruitment for patients. The listing for this trial was first posted on August 13th, 2015 and last updated on August 25th, 2022. If you are interested in other medical studies, there are presently 3595 clinical trials actively recruiting patients with fatigue and 576 studies for Exercise Intervention actively looking for patients."

Answered by AI

Recent research and studies

Journal of the National Comprehensive Cancer NetworkJournal

Combination Therapy of Physical Activity and Dexamethasone for Cancer-related Fatigue: A Phase II Randomized Double-blind Controlled Trial

Yennurajalingam, Sriram, Vicente Valero, Zhanni Lu, Diane D. Liu, Naifa L. Busaidy, James M. Reuben, Carolina Diaz Fleming, et al.. 2022. “Combination Therapy of Physical Activity and Dexamethasone for Cancer-related Fatigue: A Phase II Randomized Double-blind Controlled Trial”. Journal of the National Comprehensive Cancer Network. Harborside Press, LLC. doi:10.6004/jnccn.2021.7066.

clinicaltrials.govStudy

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

2015. "Physical Activity and Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02491632.