Study on Reducing Prednisone to Prevent High Blood Sugar in Patients with B-Cell Non-Hodgkin Lymphoma Receiving Chemotherapy

Sponsor: Wake Forest University Health Sciences

Sponsor score: 60

ClinicalTrials ID:NCT03505762

Provider View

This clinical trial is exploring whether adjusting the dose of prednisone, a steroid used in chemotherapy, can help prevent high blood sugar in patients with B-cell Non-Hodgkin Lymphoma undergoing combination chemotherapy treatment.

Patient Parameters

Program Overview

The purpose of this study is to see if reducing the dose of prednisone, a steroid used in chemotherapy, can help prevent high blood sugar in patients with B-cell Non-Hodgkin Lymphoma. Chemotherapy drugs like rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone work together to stop cancer cells from growing. By lowering the prednisone dose, researchers hope to reduce the risk of high blood sugar levels during treatment.

Description

Primary Goals:

  • To compare how often high blood sugar occurs after 3 cycles of chemotherapy between patients receiving standard or adjusted doses of prednisone.

Secondary Goals:

  • To compare high blood sugar rates after 6 cycles of treatment and 6 months after treatment between the two prednisone dosing methods.
  • To compare how well patients respond to treatment after 6 cycles using standard criteria.
  • To compare the occurrence of severe side effects between the two dosing methods.
  • To compare the severity of prednisone-related side effects reported by patients.
  • To compare the quality of life between the two dosing methods at different points during treatment.

Exploratory Goals:

  • To evaluate different blood sugar measures to estimate high blood sugar.
  • To compare quality of life in patients with and without high blood sugar after treatment.
  • To compare blood sugar variability between the two dosing methods.
  • To determine if patients can complete all six cycles of chemotherapy in both groups.

Study Design:

Participants are randomly assigned to one of two groups:

  • Group 1: Receives rituximab, vincristine, doxorubicin, and cyclophosphamide through an IV on day 1, and a tailored dose of prednisone by mouth once daily on days 1-5. Treatment repeats every 21 days for up to 6 cycles.

  • Group 2: Receives the same chemotherapy drugs as Group 1, but with the usual dose of prednisone by mouth once daily on days 1-5. Treatment repeats every 21 days for up to 6 cycles.

After completing the study treatment, participants will be followed for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with B-cell Non-Hodgkin Lymphoma.
  • Planned to receive R-CHOP chemotherapy.
  • General health status allowing for daily activities (ECOG score 0-3).
  • Expected to live more than 3 months with chemotherapy.
  • Women and men must agree to use effective birth control during the study.
  • Ability to understand and sign a consent form.

Exclusion Criteria

  • Uncontrolled HIV with very low CD4 count.
  • Diagnosis of primary central nervous system lymphoma.
  • Unable to receive R-CHOP chemotherapy.
  • Severe allergic reactions to similar drugs.
  • Uncontrolled illnesses like active infections, heart failure, or psychiatric conditions that prevent following the study.
  • Pregnant women cannot participate; breastfeeding must stop if treated with these drugs.

Locations

FACILITYZIPCITYSTATE
Wake Forest University Health Sciences27157Winston-SalemNorth Carolina

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