Clinical trial NCT02155374: Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
Official title: Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia Steroid-induced
Keywords: Glucocorticoid induced hyperglycemia, insulin, chemotherapy
Lead sponsor: Slotervaart Hospital
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Glycemic control
timeFrame: 24h till end of treatment (expected duration 4-8 days)
Secondary outcomes:
measure: Patient satisfaction
timeFrame: At the end of each treatment cycle (expected duration 4-8 days)
measure: Clinical outcomes
timeFrame: During each treatment (expected duration 4-8 days)
measure: Hypoglycemia
timeFrame: During each treatment (expected duration 4-8 days)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Slotervaart Hospital
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek hospital
city: Zwolle
country: Netherlands
facility: Isala Clinics
Study officials:
References: