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Tight Caloric Control in the Cachectic Oncologic Patient (TiCaCONCO or CoCooN) (TiCaCONCO)

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ClinicalTrials.gov Identifier: NCT03058107
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Elisabeth De Waele, Universitair Ziekenhuis Brussel

Brief Summary:
Cancer is a worldwide spread disease with high prevalence and incidence, often of poor prognosis because it is typically diagnosed in an advanced stage. Another reason for this prognosis is the presence of malnutrition, on the one hand because of a diminished intake (due to anorexia), and on the other hand because of tumor-induced hypercatabolism. The result is a pathological state of the body called "cachexia", generally defined as a weight loss > 5% during the last 6 months before diagnosis. It had already been demonstrated that correct nutrition in such patients can limit morbidity, while promoting progression-free survival as well as well-being. The pilot study, previously performed by the investigators, was the first to suggest that Nutrition Therapy, based on the ESPEN guidelines and resting energy expenditure measured by indirect calorimetry, can promote overall survival. The aim of this project is to validate these preliminary results in a larger RCT (randomized controlled double-blind trial), to promote Nutrition Therapy as a novel modality in its own right in the treatment of cancer, rather than being merely supportive.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Dietary Supplement: Nutrition Therapy Dietary Supplement: Control Therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tight Caloric Control in the Cachectic Oncologic Patient (TiCaCONCO or CoCooN) Can Stabilize Body Weight, Thereby Reducing Morbidity and Mortality: Validation of the Pilot Study - A Randomized Controlled Double-Blind Trial
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nutrition Therapy (NT) group
Nutrition Therapy is intensive dietary counseling based on practical measurements of energy expenditure, rather than calculating it using theoretic formulas or no method at all.
Dietary Supplement: Nutrition Therapy
At the time of diagnosis, patients will immediately be screened and started with Nutrition Therapy if assigned to group A. This regimen will stay in place for 6 weeks to 3 months, after which a switch will be made towards normal dietary counselling. Nutrition Therapy can be given orally, parenterally or via tube feeding (enteral nutrition), depending on the patient's status and aims at matching Caloric Intake with Resting Energy Expenditure. Moreover, a switch between these modalities is possible. Afterwards, standard dietary counselling will be given during the remainder of the study. Follow-up will last one year. If 6 months after the last enrolment the study shows a large difference with the control group, the study will be stopped for ethical reasons.
Active Comparator: Control Therapy (CT) group
Control Therapy is standard dietary counseling bij state-wide recognized onco-dietitians. Energy expenditure is never measured in this standard protocol.
Dietary Supplement: Control Therapy
At the time of diagnosis, patients will immediately be screened and started with standard dietary counselling for 1 year if assigned to group B. Dietary intervention can be orally, parenterally or via tube feeding (enteral nutrition), depending on the patient's status. Moreover, a switch between these modalities is possible. Follow-up will last 1 year. If 6 months after the last enrolment the study shows a large difference with the control group, the study will be stopped for ethical reasons.



Primary Outcome Measures :
  1. overall survival (mortality) [ Time Frame: 1 year ]
    Overall survival (OS) will be calculated for the whole group of NT vs Control (as calculated with statistical power), for men and women.


Secondary Outcome Measures :
  1. hospitalisation [ Time Frame: 1 year ]
    number of unexpected hospitalisation days

  2. morbidity [ Time Frame: 1 year ]
    SF36 questionnaire

  3. weight stabilisation (kg) [ Time Frame: 1 year ]
    The stabilisation of the patient's body weight at the end of the study will be measured on a scale (in kg).

  4. body composition (%) [ Time Frame: 1 year ]
    The BIA (bio-electric impedance analysis) will be performed at the beginning and the end of the study.

  5. energy expenditure (Kcal) [ Time Frame: 1 year ]
    Next to indirect calorimetry to asses resting energy expenditure, Sensewear technology will be used to assess the patient's total energy expenditure.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years
  • Male and female
  • Colorectal, lung, oesofageal, gastric, pancreatic or head and neck cancer before chemo- or radiotherapy is started (naive to treatment), but surgery may already have been performed OR relapse > 3 months after initial oncologic therapy
  • Oncologic cachexia (undesired weight loss > 5% in less than 6 months), before or during treatment
  • Written informed consent / ability to give informed consent

Exclusion Criteria:

  • concomitant second malignancy
  • uncertainty of diagnosis
  • patient unfit for chemotherapy, radiotherapy or surgery
  • palliative treatment or terminal patient (life expectancy < 3 months)
  • patient already participating in another study
  • Pregnancy / lactation
  • Any other pathology present that causes the patient to be unfit for oncologic therapy (e.g. end-stage renal failure, severe COLD, severe heart failure)
  • Unable to adhere to protocol instructions (e.g. language barrier)
  • Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
  • Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058107


Contacts
Contact: Elisabeth De Waele, MD, PhD elisabeth.dewaele@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Jette, Belgium, 1090
Contact: Elisabeth De Waele, MD, PhD       elisabeth.dewaele@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Baxter Healthcare Corporation
Investigators
Study Chair: Elisabeth De Waele, MD, PhD Universitair Ziekenhuis Brussel

Publications of Results:
Responsible Party: Elisabeth De Waele, MD, PhD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03058107     History of Changes
Other Study ID Numbers: 2016/307
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Elisabeth De Waele, Universitair Ziekenhuis Brussel:
Nutrition Therapy

Additional relevant MeSH terms:
Nutrition Disorders