NCT06085716 Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
| NCT ID | NCT06085716 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Metastatic Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-02-16 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 240 participants in total. It began in 2024-02-16 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 either the psychoeducational interventions or the placebo alone.
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.
Contact & Investigator
Sriram Yennu, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06085716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06085716 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06085716 currently recruiting?
Yes, NCT06085716 is actively recruiting participants. Contact the research team at syennu@mdanderson.org for enrollment information.
Where is the NCT06085716 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06085716 clinical trial?
NCT06085716 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Sriram Yennu, MD at M.D. Anderson Cancer Center. The trial plans to enroll 240 participants.
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