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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Placebo Administration; Other: Waiting List

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (open labeled placebo); Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Placebo Administration; Given open labeled placebo PO
Active Comparator: Arm II (waiting list, open labeled placebo); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Placebo Administration; Given open labeled placebo PO; Other: Waiting List; Assigned to a waiting list; Other Names: Waitlist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cancer related fatigue	Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups.	Baseline up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life (QOL)	Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups. The percentage of patients who report 'better' in each group will be reported. Will also compare the % of patients who report 'somewhat better' to "a great deal better" in each group and report the difference between groups (chi-square tests).	Baseline up to 4 weeks
Change in function strength	Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups. The percentage of patients who report 'better' in each group will be reported. Will also compare the % of patients who report 'somewhat better' to "a great deal better" in each group and report the difference between groups (chi-square tests).	Baseline up to 4 weeks
Change in Global Symptom Evaluation (GSE)	Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups. The percentage of patients who report 'better' in each group will be reported. Will also compare the % of patients who report 'somewhat better' to "a great deal better" in each group and report the difference between groups (chi-square tests).	Baseline up to 4 weeks
Changes in cluster composite scores of sleep disturbance	The primary comparison will be using changes in cluster composite scores of sleep disturbance from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.	Baseline up to 1 week
Changes in cluster composite scores of fatigue	The primary comparison will be using changes in cluster composite scores of fatigue from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.	Baseline up to 1 week
Changes in cluster composite scores of pain	The primary comparison will be using changes in cluster composite scores of pain from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.	Baseline up to 1 week
Changes in cluster composite scores of depression	The primary comparison will be using changes in cluster composite scores of depression from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.	Baseline up to 1 week
Adherence	Will use a chi-square to test the difference in adherence between each placebo group versus waitlist control group.	Up to 4 weeks
Incidence of adverse events	Will calculate the chi-square statistic to test the difference in adverse events between placebo group versus waitlist control group.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sriram Yennu, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2018-0526 (Other Identifier: M D Anderson Cancer Center); NCI-2019-01027 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No