RecruitingPhase 2/3

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

United States240 participantsStarted 2024-02-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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.

What they're measuring

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Timeframe: through study completion; an average of 1 year

Trial details

NCT IDNCT06085716

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Sriram Yennu, MD

(713) 792-3938 syennu@mdanderson.org

View on ClinicalTrials.gov More Metastatic Cancers trials