Exercise + Dexamethasone for Cancer-Related Fatigue

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

Must be taking: Dexamethasone

Disqualifiers: Uncontrolled diabetes, Sepsis, Neutropenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 4 weeks

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 6 7}

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

Hemoglobin > 8 g/L within 1 week of enrollment in the study

A life expectancy of >= 4 months

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

Exclusion Criteria

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

I have severe heart disease or serious heart artery problems.

I have fallen in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either high-dose or low-dose dexamethasone for 7 days, along with a physical activity regimen for 4 weeks

4 weeks

3 visits (in-person) per week for exercise, daily medication

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

2 visits (in-person) at day 29 and after 1 month

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?

Group I: Arm II (low dose dexamethasone, physical activity) Experimental Treatment 5 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 Treatment 5 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.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Exercise significantly improves muscle strength, exercise tolerance, and helps manage body fat and sexual function in prostate cancer patients undergoing androgen deprivation therapy (ADT), based on a meta-analysis of 15 studies with 1135 participants.

No significant differences were found between aerobic and resistance exercise in alleviating ADT-related obesity, fatigue, or exercise tolerance, and exercise duration was linked to reduced fatigue levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. Yunfeng, G., Weiyang, H., Xueyang, H., et al.[2021]

A systematic review of 11 studies with 1530 cancer patients found that supervised physical activity significantly reduces cancer-related fatigue, with a strong effect size (SMD = -1.69).

Both combined aerobic and resistance training, as well as aerobic, resistance, and stretching exercises, were effective in reducing fatigue, suggesting these should be included in cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised exercise reduces cancer-related fatigue: a systematic review. Meneses-Echávez, JF., González-Jiménez, E., Ramírez-Vélez, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10979672/

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 ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.17_suppl.LBA12098

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.

3. asco.org asco.org/abstracts-presentations/ABSTRACT277405

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 ...

4. liebertpub.com liebertpub.com/doi/10.1089/pmr.2021.0053

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-cancer

Steroids 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9883329/

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. ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392423007108

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.