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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Given open labeled placebo PO
Ancillary studies
Ancillary studies
Assigned to a waiting list
M D Anderson Cancer Center
Houston, Texas, United States
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.
Time frame: Baseline up to 1 week
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 weeks
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