Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

NCT06085716 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023-0466NCI-2023-08682
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Cancers; Fatigue

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year

Study Arms (3)

Psychoeducational Intervention

EXPERIMENTAL

Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:

Behavioral: Psychoeducational Intervention

Open Label Placebo

EXPERIMENTAL

Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:

Drug: Open Label Placebo

Psychoeducational Intervention+Placebo

EXPERIMENTAL

Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:

Behavioral: Psychoeducational Intervention+Placebo

Interventions

Open Label Placebo DRUG

This group will only take placebo capsules every day.

Open Label Placebo

Psychoeducational Intervention BEHAVIORAL

Participants in the PI group will complete the educational sessions only.

Psychoeducational Intervention

Psychoeducational Intervention+Placebo BEHAVIORAL

This group will take the placebo capsules every day, as well as completing the educational sessions.

Psychoeducational Intervention+Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)
• Able to read, write and speak English

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Centerr

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sriram Yennu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sriram Yennu, MD

CONTACT

(713) 792-3938; syennu@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)