Open-Label Placebo for the Treatment of Cancer-Related Fatigue in Patients with Advanced Cancer: A Randomized Controlled Trial

• Published in: The oncologist (Dayton, Ohio) Vol. 27; no. 12; pp. 1081 - 1089
• Main Authors: Yennurajalingam, Sriram, Azhar, Ahsan, Lu, Zhanni, Rodriguez, Ashley J, Arechiga, Adrienne B, Guerra-Sanchez, Maria, Stanton, Penny, Andersen, Clark R, Urbauer, Diana L, Bruera, Eduardo
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01-12-2022
• Subjects: Antimitotic agents; Antineoplastic agents; Cancer patients; Care and treatment; Causes of; Fatigue; Humans; Neoplasms - complications; Symptom Management and Supportive Care; Testing; United States; treatment; cancer-related fatigue; randomized control trial; placebo; fatigue cluster
• ISSN: 1083-7159; 1549-490X; 1549-490X
• DOI: 10.1093/oncolo/oyac184

The purpose of this study was to determine the effects of an open-labeled placebo (OLP) compared to a waitlist control (WL) in reducing cancer-related fatigue (CRF) in patients with advanced cancer using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
In this randomized controlled trial, patients with fatigue ≥4/10 on Edmonton Symptom Assessment Scale (ESAS) were randomized to OLP one tablet twice a day or WL for 7 days. On day 8, patients of both arms received a placebo for 3 weeks. Changes in FACIT-F from baseline to day 8 (primary outcome) and at day 29, were assessed. Secondary outcomes included FACT-G, Multidimensional Fatigue Symptom Inventory-SF, Fatigue cluster (defined as a composite of ESAS fatigue, pain, and depression), Center for epidemiologic studies-depression, Godin leisure-time physical activity questionnaire, and global symptom evaluation.
A total of 84/90 (93%) patients were evaluable. The mean (SD) FACIT-F change at day 8 was 6.6 (7.6) after OLP, vs. 2.1 (9.4) after WL (P = .016). On days 15 and 29, when all patients received OLP, there was a significant improvement in CRF and no difference between arms. There was also a significant improvement in ESAS fatigue, and fatigue cluster score in the OLP arm on day 8 of the study (0.029, and 0.044, respectively). There were no significant differences in other secondary outcomes and adverse events between groups.
Open-labeled placebo was efficacious in reducing CRF and fatigue clusters in fatigued advanced cancer patients at the end of 1 week. The improvement in fatigue was maintained for 4 weeks. Further studies are needed.