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Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
RecruitingPhase 2/3
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Psychoeducational Intervention (behavioral)
- Open Label Placebo (drug)
- Psychoeducational Intervention+Placebo (behavioral)
Sponsor: M.D. Anderson Cancer Center · Participants: 240 · Started: Feb 16, 2024
Contact the study team
- Sriram Yennu, MD · Phone: (713) 792-3938
Official record on ClinicalTrials.gov — NCT06085716
Locations in the U.S.
| Texas | MD Anderson Cancer Centerr, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.