Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer
Running, not enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
In brief
This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.
Key facts
- Study ID
- NCT03927885
- Run by
- M.D. Anderson Cancer Center
- People needed
- 100
- Starts
- 2019-03-30
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors)
- Presence of fatigue of >= 4/10 on Edmonton Symptom Assessment System (ESAS) Fatigue item (0-10 severity scale)
- Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
- Uncontrolled pain; patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry. Change in opioid dose after study entry is allowed
- Patient must be 18 years of age or older. The questionnaires used in this study have been validated only in the adult population
- Patient must be willing to engage in telephone follow up with research staff
- Patient must have telephone access to be contacted by the research staff
- Hemoglobin level of >= 8 g/dL. Patient may receive packed red blood cell (PRBC) transfusion so as to have hemoglobin level of >= 8 g/dL so at participate in the study
You may not qualify if…
- Surgery, or pain relieving procedures within 2 weeks of entry into the study or during the study period
- Patients with history of substance abuse (Cut down, Annoyed, Guilty, Eye opener [CAGE] >= 2+), cognitively impaired (MD Anderson Symptom [MDAS] > 7)
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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