Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06085716
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Fatigue
  • Metastatic Cancers

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psychoeducational Intervention — BEHAVIORAL
    Participants in the PI group will complete the educational sessions only.
  • Open Label Placebo — DRUG
    This group will only take placebo capsules every day.
  • Psychoeducational Intervention+Placebo — BEHAVIORAL
    This group will take the placebo capsules every day, as well as completing the educational sessions.

Study Details

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.

Key Dates

Start date
Feb 16, 2024
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2029

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Psychoeducational 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:
  • Experimental: Open Label Placebo
    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:
  • Experimental: Psychoeducational Intervention+Placebo
    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:

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterrHoustonTexas77030
Sriram Yennu, MD
[email protected]
713-792-3938
Sriram Yennu, MD (PRINCIPAL_INVESTIGATOR)

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