NCT04908852

Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML

A Pilot Study to Assess Feasibility and Explore Variability in Biomarkers and Patient Reported Outcome Measures in Patients Undergoing Induction Chemotherapy for Acute Myeloid Leukemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being conducted to help understand how the symptoms during treatment for acute myeloid leukemia (AML) may be affected by metabolism and how best to study this association. Symptoms include experiences like fatigue, sleep disturbance, pain, and depression.

Detailed description

This is a prospective, longitudinal, observational exploratory study. Ten participants will be enrolled and will complete baseline and week 4 blood sample collections. Symptom questionnaires will be completed at baseline, 1-, 2-, 3- and 4-weeks. This research study is a Pilot Study, which means it is the first time that researchers are studying the associations between symptoms and metabolism in this way. The National Institute of Nursing Research is supporting this research study by providing funding for the research study.

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
OTHER	Blood Sample Collection - Observational Study	Blood samples will be collected at enrollment and week 4 and used in analyses to understand associations between metabolic function and symptom experiences.
OTHER	Symptom questionnaires - Observational Study	Symptom questionnaires at baseline, 1-, 2-, 3- and 4-weeks.

Timeline

• Start date: 2021-07-26
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2021-06-01
• Last updated: 2023-04-05

Locations

1 site across 1 country: United States