Clinical trial · Interventional
Physical Activity With or Without Dexamethasone in Reducing Cancer-Related Fatigue in Patients With Locally Advanced, Metastatic, or Recurrent Cancer
A Combination Therapy for Cancer-Related Fatigue in Advanced Cancer Patients
NCT03583255CI-TRIAL-00117357active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Hematopoietic and Lymphoid System Neoplasm | Hematopoietic and Lymphatic System Neoplasm | ALIAS | 0.90 |
| Locally Advanced Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Malignant Solid Neoplasm | Malignant Solid Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Exercise Intervention | Behavioral | — | UNRESOLVED |
| Placebo Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (dexamethasone, exercise)
- description
- 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.
- interventionNames
- Drug: Dexamethasone
- Behavioral: Exercise Intervention
- type
- ACTIVE_COMPARATOR
- label
- Arm II (placebo, exercise)
- description
- Patients receive placebo PO BID for 7 days. Patients also complete resistance training and moderate intensity walking as in Arm I.
- interventionNames
- Behavioral: Exercise Intervention
- Other: Placebo Administration
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDYennurajalingam 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. PMID 39773433