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Advanced Malignant Solid NeoplasmPhase 2NCT03583255

Physical Activity With or Without Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Locally Advanced, Metastatic, or Recurrent Cancer

A Phase 2 study testing Dexamethasone and Exercise Intervention in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexamethasone and Exercise Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteUnited States
Study dates
29 Jun 2018to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of locally advanced cancer (defined as metastatic or recurrent cancer or completed 2 lines of therapy) with fatigue >= 4/10 (0-10 scale) on the Edmonton Symptom Assessment Scale (ESAS)
  • Presence of fatigue for at least 2 weeks
  • Normal cognition defined as Memorial Delirium Assessment Scale (MDAS) of =< 13/30 completed in person or via video conference
  • Hemoglobin > 8 g/L within 2 weeks of enrollment in the study
  • Zubrod performance status =< 2
  • Life expectancy of >= 4 months
  • Able to read, write, and speak English

Who cannot join

  • Patients with a history of hypersensitivity to dexamethasone or having any contraindication to physical activity as determined by the treating physician
  • Reports of a fall in the past 30 days
  • Uncontrolled diabetes mellitus as defined by a random blood sugar of > 200 mg/dl not being monitored by their primary care physician
  • Sepsis and/or acute, chronic, or ongoing infections that are currently being treated with systemic antimicrobials
  • Current, active peptic ulcer disease
  • Neutropenia as defined by an absolute neutrophil count (ANC) of < 1000 cells/mm
Show all 10Show fewer
  • Regular participation in moderate- or vigorous-intensity physical activity for >= 30 minutes at least 5 times a week and strength training for >= 2 days
  • Symptomatic cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
  • Patients currently on immunotherapy
  • Inability to comply with study protocol procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Combination Therapy for Cancer-Related Fatigue in Advanced Cancer Patients

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To test the hypotheses that patients with cancer-related fatigue (CRF) will be satisfied with the physical activity + dexamethasone (PA+ DEX) intervention, have adequate rates of adherence, and that PA+ DEX will be feasible for patients with CRF.

Ia. To determine if the combination of PA+ DEX is a feasible intervention for advanced cancer patients, as evidenced by an adherence rate to daily use of PA+ DEX greater than or equal to 75%.

Ib. To determine if patients are satisfied with PA+ DEX, based on more than 75% of patients indicating their satisfaction with PA+ DEX with a rating of "somewhat satisfied" or "completely satisfied."

SECONDARY OBJECTIVES:

  1. To test the hypothesis that PA+ DEX (PA for 4 weeks plus dexamethasone 4 mg twice a day for 1 week) will be more efficacious than PA+ placebo (PA for 4 weeks plus placebo for 1 week) on CRF as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).

Ia. To determine if PA+ DEX results in robust reduction in FACIT-F subscale scores (defined as >= 10 point improvement in 60% of patients).

II. To explore the effects of PA+ DEX on fatigue-related symptoms and function. IIa. To determine if PA+ DEX improves CRF by targeting the various associated factors of CRF.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive dexamethasone orally (PO) twice daily (BID) for 7 days. Patients also complete resistance training and moderate intensity walking at home for minimum 5 days per week over 4 weeks.

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

After completion of study, patients are followed up at 29 days and 1 month.

Being tested
Dexamethasone, Exercise Intervention, Placebo Administration
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • Exercise InterventionBehavioural

    Complete resistance training and moderate intensity walking

  • Placebo AdministrationOther

    Given PO

Study groups in NCT03583255
Study groupRoleWhat they receive
Arm I (dexamethasone, exercise)ExperimentalPatients 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.
Receives: Drug: Dexamethasone; Behavioral: Exercise Intervention
Arm II (placebo, exercise)Active comparatorPatients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.
Receives: Behavioral: Exercise Intervention; Other: Placebo Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility For Participants with Cancer-Related Fatigue (CRF)

    Will be assessed by the proportion of participants completing the intervention. Will estimate 95% confidence intervals for the proportion of patients completing the intervention.

    Measured: Up to 1 month

  2. Adherence

    Will be calculated as the mean of the % of total prescribed strength training sessions and the % of total prescribed walking regimen minutes completed (exercise), and mean (across all patients) percentage of total prescribed pills taken (study medication) as detailed above. Will estimate 95% confidence intervals for the proportion of patients completing the intervention and the adherence rate.

    Measured: Up to 1 month

  3. Satisfaction

    Will estimate 95% confidence intervals for the proportion of patients with a satisfaction rating of "somewhat satisfied" or "completely satisfied."

    Measured: Up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start29 Jun 2018
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03583255
Sponsor's protocol ID
2018-0226
Other IDs
NCI-2018-01103, 2018-0226, R21NR016737
Status last verified
Jul 2026
First submitted
28 Jun 2018
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Yennurajalingam S, Valero V, Smalgo BG, Overman MJ, Dasari A, Wolff RA, Raghav KPS, Barcenas CH, Busaidy NL, Fellman B, Basen-Engquist K, Hess KR, Tripathy D, Bruera E. Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Preliminary Placebo-Controlled, Randomized, Double-Blind Trial. J Natl Compr Canc Netw. 2025 Jan 7;23(1):e247071. doi: 10.6004/jnccn.2024.7071.

    PubMed 39773433

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone and Exercise Intervention in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphoid System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility For Participants with Cancer-Related Fatigue (CRF) (time frame: Up to 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03583255, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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