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

NCT03058107 | Completed DMC

• 1 other identifier: BUN 143201629790
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism and Nutrition Disorder

Keywords

Nutrition Therapy

Outcome Measures

Primary Outcomes (1)

• overall survival (mortality)

  Overall survival (OS) will be calculated for the whole group of NT vs Control (as calculated with statistical power), for men and women.

  1 year

Secondary Outcomes (6)

• hospitalisation

  1 year

• morbidity

  1 year

• weight stabilisation (kg)

  1 year

• body composition (%)

  1 year

• energy expenditure (Kcal)

  1 year

Study Arms (2)

Nutrition Therapy (NT) group

EXPERIMENTAL

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

Control Therapy (CT) group

ACTIVE COMPARATOR

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

Interventions

Nutrition Therapy DIETARY_SUPPLEMENT

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.

Nutrition Therapy (NT) group

Control Therapy DIETARY_SUPPLEMENT

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.

Control Therapy (CT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Baxter Healthcare Corporation: collaborator
• Nutricia, Inc.: collaborator

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

Related Publications (1)

• De Waele E, Mattens S, Honore PM, Spapen H, De Greve J, Pen JJ. Nutrition therapy in cachectic cancer patients. The Tight Caloric Control (TiCaCo) pilot trial. Appetite. 2015 Aug;91:298-301. doi: 10.1016/j.appet.2015.04.049. Epub 2015 Apr 22.

  PMID: 25912786 RESULT

MeSH Terms

Conditions

Nutrition Disorders

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Elisabeth De Waele, MD, PhD

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: February 20, 2017
• Study Start: February 1, 2017
• Primary Completion: July 10, 2020
• Study Completion: July 10, 2020
• Last Updated: December 10, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)