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Combination Therapy for Cancer-Related Fatigue

Phase 2 & 3

Recruiting

Led By Sriram Yennu, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a ECOG performance status score of 0 to 2.

Be aged 18 years or older.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

Study Summary

This trial tests if combining counseling, education, and self-therapies with a “fake” pill can improve quality of life better than either one alone.

Who is the study for?

This trial is for adults over 18 with advanced, incurable metastatic cancer experiencing significant fatigue. They must be mentally clear, able to follow the study protocol, and not severely anemic. Participants should have a reasonable level of physical functioning and receive care at MD Anderson Cancer Center or its affiliates.Check my eligibility

What is being tested?

The study tests if combining educational support and self-care strategies (psychoeducational interventions) with a known placebo can better improve life quality compared to each approach alone in managing cancer-related fatigue in patients with metastatic cancers.See study design

What are the potential side effects?

Since this trial involves psychoeducational interventions and placebos rather than drugs, side effects are minimal but may include discomfort from discussing personal issues during counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Psychoeducational Intervention+PlaceboExperimental Treatment1 Intervention

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:

Group II: Psychoeducational InterventionExperimental Treatment1 Intervention

Group III: Open Label PlaceboExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Open Label Placebo

2019

N/A

~100

Psychoeducational Intervention

2002

N/A

~310

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,268 Total Patients Enrolled

28 Trials studying Fatigue

2,631 Patients Enrolled for Fatigue

Sriram Yennu, MDPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

298 Total Patients Enrolled

1 Trials studying Fatigue

188 Patients Enrolled for Fatigue

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities to participate in this experiment presently?

"According to clinicaltrials.gov, this medical research study is not presently accepting applicants; the trial was originally posted on March 1st 2024 and last edited 10 months ago. Conversely, there are currently 3394 other studies actively recruiting patients across the globe."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

2024. "Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085716.