Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT06085716

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Led by M.D. Anderson Cancer Center · Updated on 2026-05-05

240

Participants Needed

1

Research Sites

289 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  1. 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.
  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)
  9. Able to read, write and speak English
Not Eligible

You will not qualify if you...

  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 (as documented in chart) or become pregnant while on study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Centerr

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Sriram Yennu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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