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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- hospitalisation [ Time Frame: 1 year ]number of unexpected hospitalisation days
- morbidity [ Time Frame: 1 year ]SF36 questionnaire
- 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).
- body composition (%) [ Time Frame: 1 year ]The BIA (bio-electric impedance analysis) will be performed at the beginning and the end of the study.
- 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.
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
|Contact: Elisabeth De Waele, MD, PhDemail@example.com|
|Jette, Belgium, 1090|
|Contact: Elisabeth De Waele, MD, PhD firstname.lastname@example.org|
|Study Chair:||Elisabeth De Waele, MD, PhD||Universitair Ziekenhuis Brussel|