NCT06085716 Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
| NCT ID | NCT06085716 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Metastatic Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-02-16 |
| Primary Completion | 2027-08-31 |
Trial Parameters
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Brief Summary
To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.
Eligibility Criteria
Inclusion Criteria: 1. Be advanced cancer patients (incurable metastatic), having fatigue with severity of 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale) for at least 2 weeks. 2. Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30). 3. Be aged 18 years or older. 4. Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas. 5. Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment. 6. Be able to understand the description of the study and sign a written informed consent. 7. Have a ECOG performance status score of 0 to 2; and 8. Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs) Exclusion Criteria: 1. Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or th
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