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

Not Applicable

• Conditions: Adenocarcinoma of the Esophagogastreal Junction; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer; Cholangiocarcinoma; Gastric Cancer; Esophagus Cancer
• Interventions: Procedure: Starvation

• Registration Number: NCT02607826
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28
• Study Start: 2016-11
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

1. Patient (male/female) ≥ 18 years of age

2. Written informed consent obtained prior to any trial specific procedure

3. 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).

4. Planned to receive palliative chemotherapy

5. No prior palliative chemotherapy

6. ECOG performance status of 0 or 1

7. Life expectancy of 12 weeks or more

8. 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

1. Underweight (BMI < 18.5)
2. Dysphagia
3. Insulin-dependent diabetes mellitus
4. Renal failure requiring hemo- or peritoneal dialysis
5. Pregnant or breast-feeding women
6. Drug/alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Starvation	-

Primary Outcome Measures

Name	Time	Method
Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.	Three Months	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.