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

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

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.
    

Study Type

Interventional

Primary Outcome

Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.

Condition

Cholangiocarcinoma

Intervention

Starvation

Study Arms / Comparison Groups

 Intervention arm

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

298

Start Date

November 2016

Completion Date

March 2019

Primary Completion Date

March 2019

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

NCT ID

NCT02607826

Organization ID

Starvation Study

Responsible Party

Principal Investigator

Study Sponsor

University Hospital Tuebingen

Study Sponsor

, , 

Verification Date

October 2016