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

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ClinicalTrials.gov Identifier: NCT03927885
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : August 29, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date August 29, 2022
Actual Study Start Date  ICMJE March 30, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
Change in cancer related fatigue [ Time Frame: Baseline up to 1 week ]
Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Change in quality of life (QOL) [ Time Frame: Baseline up to 4 weeks ]
    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).
  • Change in function strength [ Time Frame: Baseline up to 4 weeks ]
    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).
  • Change in Global Symptom Evaluation (GSE) [ Time Frame: Baseline up to 4 weeks ]
    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).
  • Changes in cluster composite scores of sleep disturbance [ Time Frame: Baseline up to 1 week ]
    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.
  • Changes in cluster composite scores of fatigue [ Time Frame: Baseline up to 1 week ]
    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.
  • Changes in cluster composite scores of pain [ Time Frame: Baseline up to 1 week ]
    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.
  • Changes in cluster composite scores of depression [ Time Frame: Baseline up to 1 week ]
    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.
  • Adherence [ Time Frame: Up to 4 weeks ]
    Will use a chi-square to test the difference in adherence between each placebo group versus waitlist control group.
  • Incidence of adverse events [ Time Frame: Up to 4 weeks ]
    Will calculate the chi-square statistic to test the difference in adverse events between placebo group versus waitlist control group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer
Official Title  ICMJE Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Malignant Solid Neoplasm
Intervention  ICMJE
  • Other: Placebo Administration
    Given open labeled placebo PO
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Waiting List
    Assigned to a waiting list
    Other Name: Waitlist
Study Arms  ICMJE
  • Experimental: Arm I (open labeled placebo)
    Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.
    Interventions:
    • Other: Placebo Administration
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Placebo Administration
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
    • Other: Waiting List
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 23, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927885
Other Study ID Numbers  ICMJE 2018-0526
NCI-2019-01027 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0526 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party M.D. Anderson Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE M.D. Anderson Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Sriram Yennu M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP