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

October 27, 2016 updated by: Dr. Michael Hötker, University Hospital Tuebingen
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

298

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Procedure: Starvation
Short-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration
No Intervention: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1.
Time Frame: 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.
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Starvation Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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