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

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

This study is testing if combining therapy with a placebo can help reduce fatigue in people with metastatic cancer.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06085716 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with incurable metastatic cancer experiencing moderate to severe fatigue.

Not a fit: Patients with major contraindications to placebo or significant cognitive impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from cancer-related fatigue.

How similar studies have performed: Previous studies have shown promise in using psychoeducational interventions for cancer-related fatigue, suggesting potential for success in this combined approach.

Eligibility criteria

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 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

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 this trial is running

Houston, Texas

• 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

Conditions Metastatic Cancers; Fatigue