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

• ClinicalTrials.gov Identifier: NCT03927885
• Recruitment Status: Active, not recruiting
• First Posted: April 25, 2019
• Last Update Posted: February 27, 2023
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: April 23, 2019
• First Posted Date: April 25, 2019
• Last Update Posted Date: February 27, 2023
• Actual Study Start Date: March 30, 2019
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

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

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 23, 2019): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03927885
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: M.D. Anderson Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: M.D. Anderson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Sriram Yennu; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: February 2023