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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02607826
Other study ID # Starvation Study
Secondary ID
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


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
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