Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Launched by M.D. ANDERSON CANCER CENTER · Oct 10, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new approach to help patients with advanced cancer who are experiencing significant fatigue. Researchers want to find out if combining supportive therapies like education and counseling with a placebo (a treatment that has no active ingredients but may help because of the patient's belief that it works) can improve the quality of life more than just using either the supportive therapies or the placebo alone.

To participate, patients need to be at least 18 years old, have advanced cancer that cannot be cured, and be feeling moderate fatigue for at least two weeks. They must also be able to understand the study details and agree to participate. If eligible, patients will engage in follow-ups with the research team, either in person or through calls. This trial is currently recruiting participants at MD Anderson Cancer Center, and it aims to provide insights into better managing fatigue in cancer care.

Gender

ALL

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 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.