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

BACKGROUND

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.

MATERIALS AND

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.