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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02607826
• Other study ID #: Starvation Study
• Status: Not yet recruiting
• Phase: N/A
• First received: November 4, 2015
• Last updated: October 27, 2016
• Start date: November 2016
• Est. completion date: March 2019

Study information

• Verified date: October 2016
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 298
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophagogastreal Junction
• Cholangiocarcinoma
• Colorectal Cancer
• Colorectal Neoplasms
• Esophageal Neoplasms
• Esophagus Cancer
• Gastric Cancer
• Pancreatic Ductal Adenocarcinoma
• Starvation
• Stomach Neoplasms

Intervention

Procedure:
• Starvation
Short-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes