Advanced Malignant Solid Neoplasm Clinical Trial
Official title:
Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer
Verified date | February 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Adherence | Will use a chi-square to test the difference in adherence between each placebo group versus waitlist control group. | Up to 4 weeks | |
Secondary | 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 |
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