Combining therapy to reduce cancer-related fatigue in metastatic cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of combining psychoeducational interventions with an open-label placebo to alleviate cancer-related fatigue in patients with metastatic cancers. Participants will be assigned to one of three groups: psychoeducational intervention alone, open-label placebo alone, or a combination of both. The primary objective is to determine if the combination therapy is more effective than psychoeducational intervention alone in reducing fatigue, as measured by the FACIT-F scale. Secondary objectives include assessing the impact on quality of life, mood, sleep, cognitive function, and inflammation over a period of three to six months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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 telemedicine follow-up visits with research staff, and able to complete Psychoeducational intervention either in person or virtually within Texas.
5. Have a hemoglobin level of ≥8 g/dL within 1 month (+/- 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

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

Where it's running

• MD Anderson Cancer Centerr
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Sriram Yennu, MD — M.D. Anderson Cancer Center
• Study coordinator: Sriram Yennu, MD
• Email: syennu@mdanderson.org
• Phone: (713) 792-3938

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.