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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 : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Neoplasm Cancer Fatigue Metastatic Malignant Solid Neoplasm Pain Recurrent Malignant Solid Neoplasm Other: Placebo Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Waiting List Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer
Actual Study Start Date : March 30, 2019
Estimated Primary Completion Date : August 26, 2021
Estimated Study Completion Date : August 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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: Placebo
Given open labeled placebo PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

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: Placebo
Given open labeled placebo PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 >= 9 g/dL. Patient may receive packed red blood cell (PRBC) transfusion so as to have hemoglobin level of >= 9 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927885


Contacts
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Contact: Sriram Yennu 713-792-6085 syennu@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sriram Yennu    713-792-6085      
Principal Investigator: Sriram Yennu         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sriram Yennu M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03927885     History of Changes
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 )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Neoplasms
Signs and Symptoms