Exercise +/− Dexamethasone for Cancer Fatigue

Overseen By Sriram Yennu

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Dexamethasone

Must not be taking: Immunotherapy

Disqualifiers: Uncontrolled diabetes, Sepsis, Cardiac disease, 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

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

99 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. However, if you are on immunotherapy, you cannot participate in this trial.

What data supports the effectiveness of the treatment Exercise +/− Dexamethasone for Cancer Fatigue?

Research shows that combined aerobic and resistance exercise is highly effective in reducing cancer-related fatigue, both during and after cancer treatment. Exercise interventions have been shown to improve physical function and quality of life, and may help alleviate fatigue in cancer patients. ^{1 2 3 4 5}

Is the combination of exercise and dexamethasone safe for humans?

Exercise is generally safe and effective in reducing cancer-related fatigue in people with cancer. Dexamethasone can have long-term adverse effects, but it is commonly used in cancer treatment. The combination of physical activity and dexamethasone has been studied for cancer-related fatigue, suggesting it is feasible, though long-term safety data is limited. ^{1 6 7 8 9}

How does the Exercise Intervention treatment differ from other treatments for cancer-related fatigue?

The Exercise Intervention treatment is unique because it combines physical activity with or without the drug dexamethasone to address cancer-related fatigue, offering a non-drug approach that can improve fatigue with fewer long-term side effects compared to drug-only treatments. ^{1 3 7 8 10}

What is the purpose of this trial?

This phase II/III trial studies how well physical activity with or without dexamethasone works in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body or has come back. Dexamethasone may decrease the body's immune response. Combining physical activity with dexamethasone may help to treat fatigue in patients with cancer.

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with advanced or recurrent cancer experiencing fatigue. They must have normal cognition, a hemoglobin level above 8 g/L, be able to perform daily activities with minimal assistance (Zubrod status ≤2), speak English, and have a life expectancy of at least 4 months. They can't join if they're allergic to dexamethasone, recently fell, have severe infections or neutropenia, uncontrolled diabetes, heart disease, active ulcers or are already very physically active.

Inclusion Criteria

My advanced cancer causes me significant fatigue.

I have been feeling tired for at least two weeks.

Hemoglobin > 8 g/L within 2 weeks of enrollment in the study

Exclusion Criteria

I have severe heart problems that limit my daily activities.

I am allergic to dexamethasone or my doctor says I shouldn't exercise.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dexamethasone or placebo and engage in physical activity for 4 weeks

4 weeks

5 visits (in-person or virtual) per week for exercise

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

2 visits (in-person)

Treatment Details

Interventions

• Dexamethasone
• Exercise Intervention

Trial Overview The study is testing whether exercise alone or combined with the drug dexamethasone reduces fatigue in patients with advanced cancer. Participants will either engage in physical activity only or take dexamethasone alongside exercising. Some may receive a placebo instead of the actual drug.

Participant Groups

Group I: Arm I (dexamethasone, exercise) Experimental Treatment 2 Interventions

Patients receive dexamethasone PO BID for 7 days. Patients also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.

Group II: Arm II (placebo, exercise) Active Control 2 Interventions

Patients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

A randomized controlled trial involving 119 sedentary women with breast cancer showed that a home-based moderate-intensity walking exercise program can significantly reduce fatigue levels during chemotherapy or radiation therapy, with a statistically significant effect (p=0.03) when accounting for actual exercise participation.

Despite 72% adherence to the exercise program, the overall analysis showed no group differences due to some participants in the usual care group also exercising; however, the results suggest that exercise can be an effective strategy to manage fatigue in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. Mock, V., Frangakis, C., Davidson, NE., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Which Exercise Approaches Work for Relieving Cancer-Related Fatigue? A Network Meta-analysis. [2023]

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

Impact of Different Exercise Programs on Severe Fatigue in Patients Undergoing Anticancer Treatment-A Randomized Controlled Trial. [2018]

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

Exercise manages fatigue during breast cancer treatment: a randomized controlled trial. [2022]

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

Exercise interventions for individuals with advanced cancer: A systematic review. [2022]

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

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

8. Denmark pubmed.ncbi.nlm.nih.gov

Does exercise intensity matter for fatigue during (neo-)adjuvant cancer treatment? The Phys-Can randomized clinical trial. [2021]

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

Energy Through Motion: An Activity Intervention for Cancer-Related Fatigue in an Ambulatory Infusion Center . [2018]

10. England pubmed.ncbi.nlm.nih.gov

Impact of a home-based walking intervention on outcomes of sleep quality, emotional distress, and fatigue in patients undergoing treatment for solid tumors. [2022]