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Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy (GluCon-Chemo)

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ClinicalTrials.gov Identifier: NCT02155374
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Slotervaart Hospital

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.


Condition or disease Intervention/treatment Phase
Hyperglycemia Steroid-induced Drug: Sliding scale insulin Drug: Intermediate acting insulin Behavioral: Dietary advice Drug: Glucose lowering medication Drug: Chemotherapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Glucose Control for Glucocorticoid Induced Hyperglycemia During Chemotherapy
Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: Sliding scale insulin
Other Name: Short acting insulin on a sliding scale base

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

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

Drug: Chemotherapy
Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician
Other Name: Antineoplastic therapy

Experimental: 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)
Drug: Intermediate acting insulin
Other Name: NPH insulin, insulatard

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

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

Drug: Chemotherapy
Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician
Other Name: Antineoplastic therapy




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155374


Locations
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Netherlands
Slotervaart Hospital
Amsterdam, Netherlands, 1066 EC
Antoni van Leeuwenhoek hospital
Amsterdam, Netherlands, 1066EC
Isala Clinics
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
Slotervaart Hospital

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Responsible Party: Slotervaart Hospital
ClinicalTrials.gov Identifier: NCT02155374     History of Changes
Other Study ID Numbers: NL47135.048.13
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Keywords provided by Slotervaart Hospital:
Glucocorticoid induced hyperglycemia, insulin, chemotherapy
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Glucocorticoids
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists