Combination Therapy for Cancer-Related Fatigue in Metastatic Cancers

This study is looking at ways to reduce cancer-related fatigue in people with metastatic cancers (cancers that have spread). It's testing if combining psychoeducational interventions (education, counseling, and self-managed therapies) with an open-label placebo (a pill you know is a placebo) works better than either approach alone. You could join if you are 18 or older, have advanced cancer, and have experienced fatigue for at least two weeks with a severity of 4 out of 10 or higher. The main goal is to see if the combination therapy reduces fatigue more effectively, as measured by a specific fatigue scale. The study aims to enroll 240 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 240 participants. It compares three groups: psychoeducational intervention only, open-label placebo only, and a combination of both.
What's involved
Participants in the psychoeducational intervention groups will complete educational sessions. Those in placebo groups will take placebo capsules daily.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored through study completion, which is an average of one year. Fatigue levels will also be assessed at 3 and 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06085716

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Recruiting
PHASE2Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~240 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:Psychoeducational InterventionOpen Label PlaceboPsychoeducational Intervention+Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured over through study completion; an average of 1 year
Metastatic Cancers
Fatigue
1 sites across 1 states
Texas1
  • Sriram Yennu, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0through study completion; an average of 1 year