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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise, with or without the drug dexamethasone (a corticosteroid), reduces fatigue in cancer patients whose cancer has spread or returned. Dexamethasone may lower the body's immune response, and combining it with exercise might relieve fatigue. Patients with advanced cancer who have felt tired for at least two weeks and are not regularly exercising might be suitable for this study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexamethasone might help manage cancer-related tiredness without causing major harm in the short term. However, concerns exist about serious side effects with long-term use. This suggests it could be safe for short-term use, but further research is needed to understand its long-term effects.

In contrast, exercise is a proven safe method to reduce cancer-related tiredness. Studies have demonstrated that both aerobic exercises (such as walking) and resistance exercises (such as weightlifting) can decrease tiredness and improve the quality of life for cancer patients.

In summary, while dexamethasone shows some potential, exercise remains a well-accepted method with clear benefits for managing tiredness in cancer patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores the combined impact of exercise and medication on cancer-related fatigue, a common and challenging symptom for patients. Unlike standard treatments that often rely solely on medication or lifestyle changes, this trial examines the potential synergistic effect of exercise with or without dexamethasone, a steroid known for its anti-inflammatory properties. The trial is unique in investigating whether adding resistance training and moderate-intensity walking to a regimen with a placebo or dexamethasone can offer more effective relief. This approach could lead to a more holistic and potentially more effective way to reduce fatigue, improving patients' quality of life.

What evidence suggests that this trial's treatments could be effective for cancer-related fatigue?

This trial will compare the effects of exercise alone with the combination of exercise and dexamethasone on cancer-related fatigue. Studies have shown that exercise alone can reduce cancer-related tiredness. Combining aerobic exercises, which strengthen the heart, and resistance exercises, which build muscles, appears especially effective. Research indicates that even short exercise programs, lasting less than 12 weeks, can improve tiredness in cancer patients.

Dexamethasone, a drug that may reduce swelling, has shown some promise in improving tiredness in cancer patients. It likely works by affecting certain chemicals in the body linked to fatigue. However, combining dexamethasone with exercise hasn't consistently shown better results in reducing tiredness compared to exercise alone. Both treatments generally receive support from patients who are satisfied and adhere to them. ^{1 3 5 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 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.

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

I have been feeling tired for at least two weeks.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 ... Dexamethasone is not widely used specifically for fatigue. Our results suggest an improvement in fatigue scores from T0 to T1.

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

Dexamethasone and exercise for cancer-related fatigue Conclusions: Dexamethasone and exercise did not lead to a statistically significant improvement in fatigue by FACT-Fatigue scale, although it ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39773433/

Physical Activity and Dexamethasone for Cancer-Related ... Our study found that the use of combination PA+Dex and PA+PBO for CRF was feasible and associated with high rates of satisfaction, adherence to medication and ...

4. pharmacy.wvu.edu pharmacy.wvu.edu/media/1211/dexamethasone-for-ca-fatigue.pdf

Dexamethasone for Treatment of Cancer-Related Fatigue CONCLUSIONS: • Dexamethasone showed promising results for treatment of CRF in advanced cancer patients with. ≥3 symptoms of ≥4 severity on the ESAS scale ...

5. dam.upmc.com dam.upmc.com/-/media/upmc/services/palliative-and-supportive-institute/for-professionals-and-students/the-tablet/v1n24-steroids-for-cancer-related-fatigue.pdf?la=en&rev=65da1b0f60aa413c91d1358bde23d932&hash=470450FDDBC15A27D2C400E227CA155C

Dexamethasone for Cancer-related fatigue It has been hypothesized that dexamethasone's peripheral effects on proinflammatory cytokines aids in its mechanism for improving fatigue.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36688471/

Corticosteroids for the management of cancer-related ... Corticosteroids are commonly used to improve CRF, but the benefits are unclear and there are significant adverse effects associated with long-term use.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02410382?cond=%22Small%20Cell%20Cancer%20of%20the%20Lung%22&intr=%22Dexamethasone%22&viewType=Table&rank=10

Dexamethasone for Treatment of Radiation-related Fatigue ... This study will look at how dexamethasone and placebo influence radiation fatigue, quality of life and number of treatment days missed during radiation therapy ...