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

90 Participants Needed

Trial Summary

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.

What data supports the effectiveness of this treatment for cancer-related fatigue?

Research shows that both physical activity and dexamethasone can help reduce cancer-related fatigue. While physical activity can be hard to stick with, and dexamethasone can have long-term side effects, combining them might offer a balanced approach to improve fatigue in cancer patients. ^{1 2 3 4 5}

Is the combination of exercise and dexamethasone safe for humans?

Exercise and dexamethasone have been studied separately for cancer-related fatigue, with exercise generally being safe and dexamethasone having some long-term side effects. Low-dose corticosteroids like dexamethasone can cause negative effects such as reduced muscle mass, but exercise may help counteract some adverse effects in cancer patients. ^{1 2 3 6 7}

How is the treatment of exercise combined with the drug dexamethasone unique for cancer-related fatigue?

This treatment is unique because it combines exercise, which can improve fatigue but often has low adherence, with dexamethasone, a drug that can also help but may have long-term side effects. The combination aims to enhance the benefits while potentially reducing the drawbacks of each approach when used alone. ^{1 2 6 7 8}

What is the purpose of this trial?

This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer.

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Reduction of cancer-related fatigue with dexamethasone: a double-blind, randomized, placebo-controlled trial in patients with advanced cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Incidence of fatigue and low-dose corticosteroid use in prostate cancer patients receiving systemic treatment: a meta-analysis of randomized controlled trials. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on dyspnoea in patients with cancer (ABCD): a parallel-group, double-blind, randomised, controlled trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of corticosteroids for cancer-related fatigue: A pilot randomized placebo-controlled trial of advanced cancer patients. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Essential of Immediate Exercises on Cancer-Related Fatigue in Patients with Prostate Cancer Receiving Androgen Deprivation Therapy: A Meta-Analysis of Randomized Controlled Trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Exercise overcome adverse effects among prostate cancer patients receiving androgen deprivation therapy: An update meta-analysis. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Supervised exercise reduces cancer-related fatigue: a systematic review. [2022]