Clinical trial · Interventional
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
NCT06085716CI-TRIAL-00110392recruitingPhase 2 / Phase 3ClinicalTrials.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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Metastatic Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open Label Placebo | Drug | — | UNRESOLVED |
| Psychoeducational Intervention | Behavioral | — | UNRESOLVED |
| Psychoeducational Intervention+Placebo | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Psychoeducational Intervention
- description
- Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:
- interventionNames
- Behavioral: Psychoeducational Intervention
- type
- EXPERIMENTAL
- label
- Open Label Placebo
- description
- Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:
- interventionNames
- Drug: Open Label Placebo
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be advanced cancer patients or s or have a history of advanced cancer, having fatigue with severity of ≥ 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale), and presence of fatigue 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) 9. Able to read, write and speak English Exclusion Criteria: 1. Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician. 2. Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study. 3. Be pregnant (as documented in chart) or become pregnant while on study.
References
Publications (0)
Data not yet available
No reference posted for this study.