Clinical trial NCT03927885: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Advanced Malignant Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Recurrent Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change in cancer related fatigue
timeFrame: Baseline up to 1 week
Secondary outcomes:
measure: Change in quality of life (QOL)
timeFrame: Baseline up to 4 weeks
measure: Change in function strength
timeFrame: Baseline up to 4 weeks
measure: Change in Global Symptom Evaluation (GSE)
timeFrame: Baseline up to 4 weeks
measure: Changes in cluster composite scores of sleep disturbance
timeFrame: Baseline up to 1 week
measure: Changes in cluster composite scores of fatigue
timeFrame: Baseline up to 1 week
measure: Changes in cluster composite scores of pain
timeFrame: Baseline up to 1 week
measure: Changes in cluster composite scores of depression
timeFrame: Baseline up to 1 week
measure: Adherence
timeFrame: Up to 4 weeks
measure: Incidence of adverse events
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sriram Yennu
role: PRINCIPAL_INVESTIGATOR
References: