NCT03927885

Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer

Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the effects of open labeled placebo one tablet twice a day (OLP) compared to waitlist control (WLC) for reducing cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale in fatigued advanced cancer patients at the end of one week. SECONDARY OBJECTIVES: I. To determine the preliminary efficacy open labeled placebo (OLP) and WLC on various fatigue dimensions - (Multidimensional Fatigue Symptom Inventory, MFSI-SF), depression (The Center for Epidemiologic Studies - Depression \[CES-D\]), cancer symptoms (Edmonton Symptom Assessment System \[ESAS\]), function and strength (six minute walk test, and 30-sec chair stand test), Global Symptom Evaluation (GSE), and quality of life (Functional Assessment of Cancer Therapy - General \[FACT-G\]) in these advanced cancer patients. II. To determine effects of OLP on fatigue symptom composite score (ESAS fatigue, pain and depression) at the end of 1st and 4th week. III. To examine the adherence and safety for the OLP as treatment for cancer related fatigue. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive open labeled placebo orally (PO) twice daily (BID) for 4 weeks in the absence of disease progression. ARM II: Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.

Conditions

• Advanced Malignant Solid Neoplasm
• Metastatic Malignant Solid Neoplasm
• Recurrent Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Placebo Administration	Given open labeled placebo PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Waiting List	Assigned to a waiting list

Timeline

• Start date: 2019-03-30
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2019-04-25
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States