Status:
RECRUITING
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Metastatic Cancers
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 eit...
Detailed Description
Primary Objectives: 1\. To determine if the combination therapy of PI with OLP (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06085716
Start Date
February 16 2024
End Date
August 31 2029
Last Update
October 20 2025
Active Locations (1)
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1
MD Anderson Cancer Centerr
Houston, Texas, United States, 77030