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

NCT03927885 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2018-0526NCI-2019-01027
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in quality of life (QOL)

  Baseline up to 4 weeks

• Change in function strength

  Baseline up to 4 weeks

• Change in Global Symptom Evaluation (GSE)

  Baseline up to 4 weeks

• Changes in cluster composite scores of sleep disturbance

  Baseline up to 1 week

• Changes in cluster composite scores of fatigue

  Baseline up to 1 week

Study Arms (2)

Arm I (open labeled placebo)

EXPERIMENTAL

Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression.

Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (waiting list, open labeled placebo)

ACTIVE COMPARATOR

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 Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Waiting List

Interventions

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (open labeled placebo); Arm II (waiting list, open labeled placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (open labeled placebo); Arm II (waiting list, open labeled placebo)

Placebo Administration OTHER

Given open labeled placebo PO

Arm I (open labeled placebo); Arm II (waiting list, open labeled placebo)

Waiting List OTHER

Assigned to a waiting list

Also known as: Waitlist

Arm II (waiting list, open labeled placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: March 30, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)