Actively Recruiting
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
240
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can improve quality of life better than either approach alone in patients with metastatic cancers experiencing cancer-related fatigue (CRF). This trial aims to determine if this combination therapy reduces fatigue severity and improves mood, sleep, cognitive function, and inflammation compared to psychoeducational intervention alone. Participants will be randomly assigned to one of three groups: psychoeducational intervention only, open-label placebo only, or a combination of both. The psychoeducational intervention involves completing educational sessions either in person or virtually, while the placebo group takes placebo capsules daily. The combination group receives both treatments. The study is open-label, meaning both participants and staff know the assigned treatment. During the study, participants will be assessed using various questionnaires and tests including fatigue scales, quality of life measures, mood and sleep assessments, cognitive tests, activity monitoring, and blood tests for inflammation markers. The main outcome measured is the incidence of adverse events throughout the study, lasting about one year. Participants will be followed for up to six months after treatment to evaluate lasting effects on fatigue and quality of life.
CONDITIONS
Brief Title
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with advanced or metastatic cancer and experiencing fatigue with severity of 4 or higher on a 0-10 scale for at least 2 weeks
- No clinical evidence of cognitive failure as assessed by the treating clinician
- Able and willing to complete psychoeducational interventions in person or virtually within Texas
- Hemoglobin level of 10 g/dL or higher within 2 weeks of enrollment
- Able to understand study information and provide written informed consent
- ECOG performance status score of 0 to 2
- Receiving care at MD Anderson Cancer Center's main campus or Houston Area Locations
- Able to read, write, and speak English
You will not qualify if you...
- Major contraindication to placebo, such as allergy or hypersensitivity to study medications or their constituents
- Conditions making adherence difficult as determined by the attending physician
- Unable to complete baseline assessments or understand study participation recommendations
- Pregnant or becomes pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - Up to 1 year
Participants receive assigned interventions which may include educational sessions, placebo capsules, or a combination of both to address cancer-related fatigue.
Regular visits for treatment and assessments during the study period
Duration - Up to 1 year after treatment
Participants are assessed for adverse events and improvements in fatigue and quality of life up to 1 year after treatment.
Periodic visits for outcome assessments up to 1 year
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Centerr
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sriram Yennu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here