Placebo for Cancer-Related Fatigue

Recruiting in Palo Alto (17 mi)

Sriram Yennu | MD Anderson Cancer Center

Overseen bySriram Yennu

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.

Research Team

Sriram Yennu

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced cancer experiencing fatigue for at least two weeks. They must have a hemoglobin level of >= 8 g/dL, stable pain management if on opioids, and be able to engage in telephone follow-ups. Excluded are those with recent surgery, substance abuse issues, or significant cognitive impairment.

Inclusion Criteria

My hemoglobin level is at least 8 g/dL, possibly after a transfusion.

I am 18 years old or older.

Exclusion Criteria

I have not had surgery or pain relief procedures within the last 2 weeks.

Patients with history of substance abuse (Cut down, Annoyed, Guilty, Eye opener [CAGE] >= 2+), cognitively impaired (MD Anderson Symptom [MDAS] > 7)

Treatment Details

Interventions

Open Labeled Placebo (Other)

Trial OverviewThe study compares the effects of an openly labeled placebo (patients know they're taking a placebo) against a waitlist control group to see which reduces cancer-related fatigue better in patients with advanced cancer.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (open labeled placebo)Experimental Treatment3 Interventions

Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.

Group II: Arm II (waiting list, open labeled placebo)Active Control4 Interventions

Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.