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Completed

NCT Number: NCT02155374

Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

Objective: to determine which regimen results in best glycemic control and safety profile, expressed as glucose values within target range and occurrence of hypoglycemia. Secondary objective is to compare patient satisfaction, clinical outcomes and toxicity.

Study design: Randomized open label cross-over study Study population: Patients ≥ 18 years, who developed glucocorticoid induced hyperglycemia requiring initiation or adjustment of antihyperglycemic agents in a previous chemotherapy cycle. Patient should have ≥2 cycles of chemotherapy scheduled, with 3-10 consecutive days of ≥12,5mg prednisone-equivalent glucocorticoid and a wash-out period of 4-38 days between each cycle.

Intervention: subjects will be treated by insulin regimen A and B in random order during two consecutive cycles of chemotherapy. A) intermediate acting insulin 0.01 IU / mg prednisone-equivalent / kg body weight once daily subcutaneous B) Short-acting insulin according to sliding scale regimen, dose adjusted to current grade of hyperglycemia.

Main study parameters: Difference in fraction of blood glucose measurements (BGM) within target range and occurrence of hypoglycemia.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both study treatments are just a slight variation in regular care for glucocorticoid induced hyperglycemia. Glycemic control is likely to improve due to treatments and increased counselling. All subjects will receive both treatment regimens.

The burden consists of 16-32 extra BGMs over 2 x 4-10 days, wearing the glucose sensor, 1 venipuncture (if HbA1c and creatinin are not determined in routine laboratory within 3 months before start), and 1 randomization visit to the outpatient clinic. Potential risk is the occurrence of hypoglycemia, as is present in any insulin therapy. The investigators account for this risk by giving subjects dietary advice and education how to prevent, recognize and treat hypoglycemia.

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Key information

Conditions

Hyperglycemia Steroid-induced Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Antoni van Leeuwenhoek hospital, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Written informed consent
  • Glucocorticoid induced hyperglycemia in previous cycle of chemotherapy that required therapy initiation or adjustment
  • Duration of glucocorticoid cycles 3-10 consecutive days and 4-38 glucocorticoid-free days between 2 cycles
  • Prednisone-equivalent dose of ≥ 12,5mg
  • At least 2 more cycles of chemotherapy to receive

Exclusion criteria

  • History of hypo-unawareness
  • Continuous tube or parental feeding
  • Continuous (maintenance) systemic glucocorticoid therapy

Treatment and study plan

Sliding scale insulin

Drug

Other names: Short acting insulin on a sliding scale base

Intermediate acting insulin

Drug

Other names: NPH insulin, insulatard

Dietary Advice

Behavioral

Dietary advice to avoid food products with high glycemic index / high glucose load

Glucose lowering medication

Drug

Regular glucose lowering medication as prescribed by the patient's own physician before study entry

Chemotherapy

Drug

Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician

Other names: Antineoplastic therapy

Primary outcomes

  1. Glycemic control

    Time frame: 24h till end of treatment (expected duration 4-8 days)

    Compare achievement of glycemic control in SSI therapy and intermediate acting insulin. Glycemic control is measured as the proportion of blood glucose measurements (BGM) within target range in each subject after 24h of treatment

Secondary outcomes

  1. Patient satisfaction

    Time frame: At the end of each treatment cycle (expected duration 4-8 days)

    Compare patient satisfaction in each treatment regimen at a 6-point Likert scale, in the last cycle we evaluate patient's preference for glucose lowering treatment in next chemotherapy cycle (SSI or intermediate acting insulin)

  2. Clinical outcomes

    Time frame: During each treatment (expected duration 4-8 days)

    Difference in clinical outcomes: incidence of oral candidiasis, pooled incidence of grade 3-4 chemotoxicity. Data on clinical outcomes will be collected by taking the patient history at the end of each treatment cycle.

  3. Hypoglycemia

    Time frame: During each treatment (expected duration 4-8 days)

    Incidence of hypoglycemia in each treatment cycle defined as an interstitial glucose ≤ 3.9 mmol/l continuing until the interstitial glucose is >3.9 mmol/l

Sponsors and collaborators

Lead sponsor

Slotervaart Hospital

Other

Registry information

Acronym: GluCon-Chemo

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 4, 2014
Registry last updated
Jan 7, 2016

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

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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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