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Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors

ConditionsOlanzapineBreast CancerDexamethasone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorAlexandria University

About this trial

The aim of THE STUDY to determine whether an olanzapine-based dexamethasone-sparing antiemetic regimen is non-inferior to the standard dexamethasone-containing regimen in preventing delayed-phase Chemotherapy-induced nausea and vomiting while reducing metabolic toxicity in breast cancer patients with metabolic risk factors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients ≥18 years.

Stage I-III breast cancer.

Scheduled to receive AC chemotherapy.

Presence of metabolic risk factors (diabetes, prediabetes, obesity, metabolic syndrome).

Disqualifiers

Recent systemic corticosteroid use.

Active nausea or vomiting before chemotherapy.

Severe renal or hepatic impairment.

Uncontrolled diabetes or hypertension.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pantoprazole

    Drug

    Administered as 40 mg orally once daily on Days 1 to 3 (1 hour before breakfast) in both arms as standard gastroprotective co-medication to prevent chemotherapy- and corticosteroid-induced gastritis and dyspepsia.

  • olanzapine

    Drug

    Administered as 5 mg orally once daily at bedtime, Days 1-3, for delayed-phase antiemetic prophylaxis.

  • Dexamethasone

    Drug

    Administered as 4 mg orally twice daily (total 8 mg/day), Days 1-3, for delayed-phase antiemetic prophylaxis.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Olanzapine-Based Dexamethasone-Sparing RegimenExperimental treatment 2 interventions
Group B: Dexamethasone-Containing Standard RegimenActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Complete response during the delayed phase chemotherapy-Induced Nausea and Vomiting (CINV)

Proportion of patients with no emetic episodes and no use of rescue antiemetic medication during the delayed phase, comparing the olanzapine-based dexamethasone-sparing regimen (Arm A) to the standard dexamethasone-containing regimen (Arm B).

Time frame
24-120 hours after initiation of AC chemotherapy (Day 0)
2

Total Control during the delayed phase

Proportion of patients with no emetic episodes, no use of rescue antiemetic medication, and no nausea during the delayed phase, comparing the two treatment arms.

Time frame
24-120 hours after initiation of AC chemotherapy (Day 0)

Secondary outcomes

1

Change in Fasting Plasma Glucose

Mean change in fasting plasma glucose (FBG) levels from Baseline (Day 0) to Peak Toxicity (Day 4) and Recovery Phase (Day 21), comparing the olanzapine-based and dexamethasone-based arms.

Time frame
Baseline (Day 0), Day 4, and Day 21
2

Change in Insulin Resistance (HOMA-IR)

Mean change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated from fasting glucose and insulin levels, from Baseline (Day 0) to Peak Toxicity (Day 4) and Recovery Phase (Day 21).

Time frame
Baseline (Day 0), Day 4, and Day 21
3

Purine Turnover / Metabolic Marker (Uric Acid) Assessment

Mean changes in serum uric acid levels from Baseline (Day 0) to Day 4 and Day 21 to monitor short-term metabolic cellular turnover and hyperuricemia risk.

Time frame
Baseline (Day 0), Day 4, and Day 21
4

Incidence of Hyperglycemia

Proportion of patients developing hyperglycemia (defined per protocol threshold) at any post-baseline assessment, compared between treatment arms.

Time frame
From Baseline (Day 0) through Recovery Phase (Day 21)

Other outcomes

1

Odds Ratios for Baseline Predictors of Metabolic Toxicity (Exploratory Logistic Regression)

Exploratory multivariable logistic regression to estimate the odds ratio (OR) and 95% confidence interval for each candidate baseline predictor - HOMA-IR (continuous), BMI in kg/m² (continuous), and stratum assignment (Stratum R1: Glycemic Risk vs. Stratum R2: Metabolic Risk) - associated with development of metabolic toxicity (defined per protocol) during the study period. All predictors will be reported using the same summary metric (odds ratio), so results are presented in a single outcome measure.

Time frame
Baseline (Day 0) through Recovery Phase (Day 21)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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