Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors

Study Overview
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Brief Summary
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Recent pre-clinical data provide strong evidence that short-term starvation before the administration of cytostatic drugs for the chemotherapy of solid tumors leads to significantly higher efficacy and lower toxicity levels. However, these findings have so far not been validated in patients. The aim of this trial is to provide first clinical evidence regarding the impact of pre-chemotherapeutic short-term starvation on response to therapy (primary endpoint). Additionally, progression-free survival, adverse events, and overall survival will be monitored (secondary endpoints). In perspective, short-term starvation before chemotherapy could represent a simple and secure way to improve both efficacy and tolerance of chemotherapies at low cost.

Official Title
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Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors

Conditions
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Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Gastric Cancer, Adenocarcinoma of the Esophagogastreal Junction, Esophagus Cancer

Intervention / Treatment
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* Procedure: Starvation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient (male/female) ≥ 18 years of age Written informed consent obtained prior to any trial specific procedure Patient suffering from gastrointestinal tumors: Cholangiocarcinoma (CC), Pancreatic ductal adenocarcinoma (PDAC), Colorectal Cancer (CRC), Gastric Cancer (GC)/ Adenocarcinoma of the Esophagogastreal Junction (AEG) / Esophagus cancer (EC). Planned to receive palliative chemotherapy No prior palliative chemotherapy ECOG performance status of 0 or 1 Life expectancy of 12 weeks or more Adequate hematological parameters, as demonstrated by: Hemoglobin > 9.0 g/dl (5.6 mmol/l) WBC ≥ 3.0 x 109/l ANC ≥ 1500/mm³ Platelets ≥ 75 x 109/l S-creatinine ≤ 1.5 mg/dl (132 µmol/l) Exclusion Criteria: Underweight (BMI < 18.5) Dysphagia Insulin-dependent diabetes mellitus Renal failure requiring hemo- or peritoneal dialysis Pregnant or breast-feeding women Drug/alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br> | Procedure: Starvation<br>* Short-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1. | Primary endpoint of this study is to assess the improvement in response to therapy for patients undergoing short-term starvation before chemotherapy of solid tumors in comparison to patients without dietary restrictions. Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1. | Three Months |