Back to resultsShort-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
Primary Purpose
Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Starvation
Sponsored by
About this trial
This is an interventional supportive care trial for Cholangiocarcinoma
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Standard of Care
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02607826
First Posted
November 4, 2015
Last Updated
October 27, 2016
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02607826
Brief Title
Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
Official Title
Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Gastric Cancer, Adenocarcinoma of the Esophagogastreal Junction, Esophagus Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Starvation
Intervention Description
Short-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration
Primary Outcome Measure Information:
Title
Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.
Description
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.
Time Frame
Three Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
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