Exercise + Dexamethasone for Cancer-Related Fatigue
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how well physical activity and dexamethasone, a medication for tiredness and pain, reduce fatigue in people with advanced cancer. It compares the effects of high-dose and low-dose dexamethasone (a corticosteroid) alongside exercise routines to determine the most effective combination. Participants will engage in resistance exercises three times a week and walking five times a week for four weeks. The trial seeks individuals with advanced cancer who have experienced significant fatigue for at least two weeks. As a Phase 2 and Phase 3 trial, it measures treatment effectiveness in a smaller group and represents the final step before FDA approval, offering a chance to contribute to important research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that dexamethasone, a medication under study for cancer-related fatigue, is generally well-tolerated by patients. Studies have found that both high and low doses of dexamethasone can reduce fatigue and improve the overall quality of life for cancer patients.
For high doses, research indicates that dexamethasone can enhance fatigue relief and sleep quality. However, taking more than 8 mg per day for over two weeks may lead to serious side effects.
Low doses of dexamethasone aim to reduce fatigue with fewer risks, offering potential benefits while requiring monitoring for any long-term side effects.
Overall, dexamethasone appears effective for cancer-related fatigue, but the dose and duration must be carefully managed to avoid negative effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores the combination of dexamethasone, a steroid, with a structured exercise program to tackle cancer-related fatigue. Unlike standard treatments that often rely solely on medications or lifestyle changes, this method integrates high- or low-dose dexamethasone with both resistance exercises and regular walking. This combination aims to not only reduce fatigue more effectively but also improve overall physical well-being. By adjusting exercise intensity based on individual progress, this approach offers a personalized and potentially more efficient way to address fatigue in cancer patients.
What evidence suggests that this trial's treatments could be effective for reducing cancer-related fatigue?
This trial will compare the effects of high-dose versus low-dose dexamethasone combined with exercise on cancer-related fatigue. Research has shown that both high and low doses of dexamethasone, when paired with exercise, can reduce cancer-related fatigue. In previous studies, participants in the high-dose dexamethasone group, combined with exercise, demonstrated significant improvements in tiredness, quality of life, and sleep. Meanwhile, about half of the patients in the low-dose dexamethasone group experienced a significant reduction in fatigue by day 29. Both treatment options led to improvements in tiredness lasting up to three weeks. Overall, combining dexamethasone with exercise appears to effectively manage fatigue in patients with advanced cancer.12467
Who Is on the Research Team?
Sriram Yennu
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either high-dose or low-dose dexamethasone for 7 days, along with a physical activity regimen for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Exercise Intervention
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Published Research Related to This Trial
Citations
Use of Dexamethasone for Severe Fatigue in the ...
Our results suggest that a once-daily dose of dexamethasone may lead to an improvement in fatigue scores over time, and that dexamethasone is ...
Dexamethasone and exercise for cancer-related fatigue
The intervention significantly improved QoL fatigue symptom score and reduced physical fatigue on QoL, along with improving sleep quality.
A phase II randomized double blind study.
Conclusions: Short course of dexamethasone Plus physical activity resulted in sustained and robust improvement in CRF outcomes for upto 3 weeks after ...
Dexamethasone 8 mg for Cancer-Related Fatigue in ...
This study failed to achieve the preset efficacy. However, dexamethasone 8 mg improved fatigue, appetite, ACS, and PWB, and was tolerable among ...
5.
jhoponline.com
jhoponline.com/web-exclusives/steroids-plus-exercise-reduce-fatigue-in-patients-with-advanced-cancerSteroids plus Exercise Reduce Fatigue in Patients with ...
A total of 60 patients were evaluable, showing significant reductions in cancer-related fatigue, with a score of 0.49 with 4-mg dexamethasone and 0.45 with 8-mg ...
Management of Fatigue in Patients with Advanced Cancer
In patients towards the end-of-life, there is some evidence in favour of short-term use of dexamethasone, but other interventions (e.g. ...
Impact of Dosing and Duration of Dexamethasone on ...
Conclusion. Dexamethasone use may contribute to serious AEs in cancer patients, especially at doses >8 mg/day and when used for more than two weeks.
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