Clinical trial · Interventional
The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors
NCT02522988CI-TRIAL-00054078OLPIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Open-label placebo intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1a
- description
- During the first 3-week period of the study, Group 1 will serve as the experimental arm and will receive the open-label placebo intervention. Group 1 participants will take 2 placebos in the morning and 2 placebos in the evening for 21 days.
- interventionNames
- Behavioral: Open-label placebo intervention
- type
- NO_INTERVENTION
- label
- Group 2a
- description
- During the first 3-week period of the study, Group 2 will serve as the comparator arm.
- type
- NO_INTERVENTION
- label
- Group 1b
- description
- During the last 3-week period of the study, Group 1 will serve as the comparator arm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of Stage II - IV cancer; * Completed primary treatment 6months to 10 years; * Report ≥4 (moderate fatigue) on a 0-10 fatigue severity rating scale; * Agree not to change any medications or treatments during the study; * Willingness to make 4 clinical site visits over the course of the 49-day study. Exclusion Criteria: * Stage 1 cancer; * Uncontrolled diabetes; * Uncontrolled COPD; * Uncontrolled ischemic heart disease; * Uncontrolled liver/kidney diseases; * Uncontrolled autoimmune diseases; * Uncontrolled psychiatric or cognitive diseases.
References
Publications (4)
- BACKGROUNDKelley JM, Kaptchuk TJ, Cusin C, Lipkin S, Fava M. Open-label placebo for major depressive disorder: a pilot randomized controlled trial. Psychother Psychosom. 2012;81(5):312-4. doi: 10.1159/000337053. Epub 2012 Aug 1. No abstract available. PMID 22854752
- BACKGROUNDKam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175. PMID 24401940
- RESULTKaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591. PMID 21203519
- DERIVEDHoenemeyer TW, Baidwan NK, Hall K, Kaptchuk TJ, Fontaine KR, Mehta TS. An Exploratory Analysis of the Association Between Catechol-O-Methyltransferase and Response to a Randomized Open-Label Placebo Treatment for Cancer-Related Fatigue. Front Psychiatry. 2021 Jun 29;12:684556. doi: 10.3389/fpsyt.2021.684556. eCollection 2021. PMID 34267689