Improvement of Fatigue Due to Placebo in Blinded and Open Labeled Cancer Fatigue Treatment Trials

The purpose of this study was to compare the placebo response i.e., improvement of cancer-related fatigue (CRF) between cohorts of advanced cancer patients who received placebo as part of CRF clinical trials in a blinded fashion, and as open-label for treatment of CRF.

In this study, data of advanced cancer patients from randomized controlled CRF clinical treatment trials who received placebo in a blinded, and as an open labeled design at a tertiary cancer center were reviewed. Demographic data, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Edmonton Symptom Assessment Scale (ESAS) scores were pooled, and changes in FACIT-F (placebo response), from baseline to day eight in the two cohorts were compared. We also examined the association of placebo response with demographics factors, FACT-G, and its sub scales, ESAS symptoms, and ESAS symptom distress scores.

We found no significant differences in placebo response between the blinded and open label cohorts (6.6 vs. 7.9, -1.3 [P = 0.87]). We found significant association between placebo response and baseline FACIT-F -3.5 (P = 0.0001), gastrointestinal cancers 5.2 (P = 0.02), ESAS- pain 0.70 (P = 0.04), ESAS anxiety 1.3 (P = 0.003), and ESAS-Symptom Distress Score -0.53 (P = 0.012).

In this study we found placebo response was not significantly different between patients receiving placebo in a blinded and open-labeled design in randomized controlled CRF clinical trials. In this study we found a significant association between placebo response and baseline CRF, gastrointestinal cancers, ESAS- pain, anxiety and ESAS-Symptom Distress Score. Further research is needed.