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

NCT ID: NCT02607826

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cholangiocarcinoma Pancreatic Ductal Adenocarcinoma Colorectal Cancer Gastric Cancer Adenocarcinoma of the Esophagogastreal Junction Esophagus Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention arm

Group Type EXPERIMENTAL

Starvation

Intervention Type PROCEDURE

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

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Starvation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Dr. Michael Hötker

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Starvation Study

Identifier Type: -

Identifier Source: org_study_id