RecruitingPhase 2Phase 3NCT06085716

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Sponsor

M.D. Anderson Cancer Center

Enrollment

240 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

Fatigue Metastatic Cancers

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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.
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)

Exclusion Criteria3

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 or become pregnant while on study.

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