CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 240 target
Drug / intervention
Open Label Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06085716
NCT06085716Phase 3RecruitingOn Track
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Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

M.D. Anderson Cancer Center·interventional·Posted Oct 17, 2023·Updated May 5, 2026

In Brief

A Phase 3 clinical trial evaluating Psychoeducational Intervention, Open Label Placebo, and 1 other intervention for Metastatic Cancers and Fatigue. Currently recruiting, targeting 240 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancers, Fatigue
CountriesUnited States
Collaborators--

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedOct 17, 2023
Enrollment StartFeb 16, 2024
Primary CompletionAug 31, 2027
Study CompletionAug 31, 2029
TodayJul 1, 2026
Enrollment to primary: 3.5 yearsPosted 2.7 years agoPrimary completion in 1.2 years

Interventions

Psychoeducational Interventionbehavioral

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

Open Label Placebodrug

This group will only take placebo capsules every day.

Psychoeducational Intervention+Placebobehavioral

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