Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy

NCT ID: NCT02155374

Last Updated: 2016-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Hyperglycemia Steroid-induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sliding scale insulin

Sliding scale insulin Glucose 7.8-12 mmol/l --\> 2 IU insulin, glucose 12.1-17 mmol/l --\> 4 IU insulin, glucose ≥17.1 mmol/l --\> 6 IU insulin. In case of insufficient control, insulin doses will be increased

Group Type: ACTIVE_COMPARATOR

Sliding scale insulin

Intervention Type: DRUG

Dietary advice

Intervention Type: BEHAVIORAL

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

Glucose lowering medication

Intervention Type: DRUG

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

Chemotherapy

Intervention Type: DRUG

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

Intermediate acting insulin

Intermediate acting insulin, 0.01 IU / mg prednison / kg body weight with a maximum of 0.5 unit insulin per kg body weight. In case of age \> 70 years or diminished renal function (GFR \<30ml/min)

Group Type: EXPERIMENTAL

Intermediate acting insulin

Intervention Type: DRUG

Dietary advice

Intervention Type: BEHAVIORAL

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

Glucose lowering medication

Intervention Type: DRUG

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

Chemotherapy

Intervention Type: DRUG

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

Interventions

Sliding scale insulin

Intervention Type: DRUG

Intermediate acting insulin

Intervention Type: DRUG

Dietary advice

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

Intervention Type: BEHAVIORAL

Glucose lowering medication

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

Intervention Type: DRUG

Chemotherapy

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

Intervention Type: DRUG

Other Intervention Names

Short acting insulin on a sliding scale base; NPH insulin, insulatard; Antineoplastic therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Slotervaart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Slotervaart Hospital

Amsterdam, , Netherlands

Antoni van Leeuwenhoek hospital

Amsterdam, , Netherlands

Isala Clinics

Zwolle, , Netherlands

Countries

Netherlands

Other Identifiers

NL47135.048.13

Identifier Type: -

Identifier Source: org_study_id