A Phase 2 interventional study of Dexamethasone and Exercise Intervention in Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid System Neoplasm and Locally Advanced Malignant Solid Neoplasm, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Supportive care
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 99 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
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Exclusion Criteria:
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.
Drug: Dexamethasone · Behavioral: Exercise Intervention
Patients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.
Behavioral: Exercise Intervention · Other: Placebo Administration
Given PO
Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycadron, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decadron DP, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasone Intensol, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Dxevo, Fluorodelta, Fortecortin, Gammacorten, Hemady, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, TaperDex, Visumetazone, ZoDex
Complete resistance training and moderate intensity walking
Given PO
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
Satisfaction
Will estimate 95% confidence intervals for the proportion of patients with a satisfaction rating of "somewhat satisfied" or "completely satisfied."
Time frame: Up to 1 month
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center