Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

• Status: Recruiting
• Trial end date: 2029-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center

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 engage in follow-up in person or by telephone or virtual calls with research staff.

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 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 or become pregnant while on study.