Researchers assessed the efficacy of open-label placebo (OLP) use in countering cancer-related fatigue (CRF), in comparison with a waitlist control. Results of the study were published in the journal The Oncologist.

“The most interesting aspect of our study was that we found improvement in CRF with the administration of a placebo given on an open-label basis in patients with advanced cancer,” the researchers said in their report.

Patients in randomized controlled trials regarding CRF have in some cases not shown significant improvements with pharmacologic agents, in comparison with placebo use. Additionally, the researchers noted that OLP use appeared associated with improvements in various symptoms in some studies.

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In this analysis, the researchers aimed to measure outcomes for CRF in patients randomized 1:1 to either receive an OLP or be placed into a waitlist control arm. After 7 days, patients in the waitlist control arm crossed over to the OLP arm, and all patients were assigned to receive the placebo for 3 weeks, beginning on day 8.

The primary outcome involved changes on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) from baseline to day 8. Secondary outcomes involved FACIT-F outcomes at day 29 and results from the Functional Assessment of Cancer Illness Therapy (FACT) and Edmonton Symptom Assessment Scale (ESAS) questionnaires, and others.

There were 90 patients in the study, of whom 93% were evaluable for analysis. From baseline to day 8, the mean FACIT-F changes were 6.6 (SD, 7.6) in the OLP arm and 2.1 (SD, 9.4) in the waitlist control arm (P =.016).

There was no difference between treatment arms in FACIT-F scores when measured on days 15 and 29, time points at which all patients were receiving placebo. Significantly reduced CRF was demonstrated for patients in the OLP arm on day 8 based on scores related to ESAS fatigue (P =.029) and the ESAS fatigue cluster (P =.044), with the fatigue cluster including fatigue, pain, and depression.

Patients in the waitlist control group had significantly better scores on FACT-General total (P =.002) and FACT emotional well-being (P =.030) analyses at day 8. Various other analyses revealed no significant differences between treatment arms and across time points. Rates of adverse events were also similar between treatment arms.

“In this study, we found that OLP significantly improved CRF (FACIT-F) in patients with advanced cancer,” the researchers stated in their report. Improvements were also reported in ESAS fatigue and ESAS fatigue cluster scores. They suggested more research was justified in exploring the use of this intervention.

Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Yennurajalingam S, Azhar A, Lu Z, et al. Open-label placebo for the treatment of cancer-related fatigue in patients with advanced cancer: a randomized controlled trial. Oncologist. Published September 15, 2022. doi:10.1093/oncolo/oyac184