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NCT Number: NCT04473378

Glucose Monitoring During Chemotherapy

This is a research study to look at blood sugar changes during chemotherapy using a continuous blood sugar monitoring device. The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course. Each patch lasts for about 2-weeks. During chemotherapy visits, new patches will be placed and will be worn until the chemotherapy course is complete. Participants will be in this study for 6 months. Approximately 50 patients will be enrolled in this study.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herbert Irving Pavilion

New York, 10032, United States

About this study

This is a prospective observational cohort study monitoring trends in glucose in patients with early stage breast cancer treated with neoadjuvant or adjuvant chemotherapy. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for the duration of chemotherapy. The primary goal of this trial is to evaluate the prevalence of hyperglycemia in patients with early-stage breast cancer during neoadjuvant/adjuvant chemotherapy. Fifty patients will be enrolled. During each chemotherapy encounter, subjects will have their glucose sensor scanned in order to download subjects' glucose data. If the sensor has become no longer adherent to the participant's skin, participants will bring the sensor with them to the chemotherapy infusion center to be scanned. During each chemotherapy encounter, the Free Style Libre sensor will be replaced by the study team. Participants who receive chemotherapy every three weeks will be asked to come in 10-14 days after their chemotherapy infusion to replace the sensor. The sensors will be worn through completion of chemotherapy (the duration will vary based on the individual's chemotherapy regimen). Patients will have fructosamine, a glucose biomarker, and serum creatinine testing at baseline and every 3 weeks (weeks 3, 6, 9, 12, 15, 18, 21, 24) until week 24 (note: week 15, 18, and 21 are optional). Patients will have additional glucose biomarker testing (hemoglobin a1c, glucose, and insulin [fasting preferred]) at baseline, week 12 and week 24. Patients will also complete questionnaires assessing for symptoms of chemotherapy induced peripheral neuropathy, quality of life, and fatigue at baseline, week 12 and week 24. Visits will be conducted within the below specified windows forbidding unexpected circumstances such as missed appointments or loss to follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • History of stage I-III breast cancer
  • Patient scheduled to receive adjuvant or neoadjuvant chemotherapy
  • Signed informed consent

Exclusion criteria

  • Current treatment with insulin
  • Current treatment with non-topical steroids, with the exception of steroid treatment as a supportive chemotherapy medication
  • Inability to provide informed consent

Treatment and study plan

FreeStyle Libre Pro

Device

The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course.

Primary outcomes

  1. Prevalence of hyperglycemia

    Time frame: 24 weeks

    assess the prevalence of HG, defined as the number of participants who have ≥1 glucose value of ≥140 mg/dL at any point during chemotherapy

Secondary outcomes

  1. Prevalence of impaired glucose tolerance at baseline in nondiabetic patients.

    Time frame: Baseline

    Prevalence of glucose intolerance will be defined as a hemoglobin a1c >5.7% at baseline in nondiabetic patients The American Diabetes Association classifies individuals with a hemoglobin A1c level of 5.7-6.4% as having an increased risk of DM.The American Diabetes Association classified individuals with a hemoglobin A1c level of 6.5% or higher on two separate occasions as having a diagnosis of DM.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS)-29

    Time frame: Baseline, week 12, and week 24

    The PROMIS-29 consists of 29 questions to measure global quality of life, including four questions from each of the following domains: anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, satisfaction with participation in social roles, ability to participate in social roles and activities; it includes a single pain intensity item.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Pilot Study of Glucose Monitoring to Determine Rates of Hyperglycemia During Chemotherapy for Early Stage Breast Cancer

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2020
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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