CholangiocarcinomaNCT02607826
Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
A study testing Starvation in people with Cholangiocarcinoma and Pancreatic Ductal Adenocarcinoma, run by University Hospital Tuebingen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer
- What is being tested?
- Starvation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- Underweight (BMI < 18.5)
- Dysphagia
- Insulin-dependent diabetes mellitus
- Renal failure requiring hemo- or peritoneal dialysis
- Pregnant or breast-feeding women
- Drug/alcohol abuse
About this study
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.
- Conditions
- Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Gastric Cancer, Adenocarcinoma of the Esophagogastreal Junction, Esophagus Cancer
- Being tested
- Starvation
- Medical subject headings
- Cholangiocarcinoma, Colorectal Neoplasms, Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StarvationProcedure or surgery
Short-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Procedure: Starvation |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Michael Hötker, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607826
- Sponsor's protocol ID
- Starvation Study
- Status last verified
- Oct 2016
- First submitted
- 4 Nov 2015
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors
- ClinicalTrials.gov ID
- NCT02607826
- Acronym / sponsor ID
- Starvation Study
- Conditions
- Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Gastric Cancer, Adenocarcinoma of the Esophagogastreal Junction, Esophagus Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: Starvation |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- Underweight (BMI < 18.5)
- Dysphagia
- Insulin-dependent diabetes mellitus
- Renal failure requiring hemo- or peritoneal dialysis
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StarvationShort-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration | Procedure or surgery | Intervention arm |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Starvation in people with Cholangiocarcinoma and Pancreatic Ductal Adenocarcinoma, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to therapy on MRI or CT scancs will be measured using the RECIST criteria version 1.1. (time frame: Three Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.