Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Recruiting now · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Metastatic Cancers, Fatigue

In brief

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.

Key facts

Study ID

NCT06085716

Run by

M.D. Anderson Cancer Center

People needed

240

Starts

2024-02-16

Expected to finish

2029-08-31

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).
• Be aged 18 years or older.
• Be willing to complete in-person or with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.
• Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.
• Be able to understand the description of the study and sign a written informed consent.
• Have a ECOG performance status score of 0 to 2; and
• Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)
• Able to read, write and speak English

You may not qualify if…

• 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.
• Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
• Be pregnant (as documented in chart) or become pregnant while on study.

Where it is running

• MD Anderson Cancer Centerr — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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