Plain English Summary
Background and study aims
Cancer and treatment for cancer can affect a person’s appetite and how they digest, absorb and use food. This can lead to malnutrition. Cancer-related malnutrition can make a person feel tired, weak and not well enough to be treated for the disease and it is a major cause of death in cancer patients.
The role of energy metabolism (that is, the process of getting and using energy from food) in cancer malnutrition remains unclear. Resting energy expenditure (REE) is the amount of energy that is used over a 24 hour period expended in 24 hours by the body at rest. The objective of the study is to determine the relationship between cancer malnutrition, cancer survival and energy expenditure.
Who can participate?
Cancer patients over the age of 18 and being treated at the Cochin Teaching Hospital.
What does the study involve?
All participants have their REE measured by a method called indirect calorimetry before they start chemotherapy treatment. This involves by measuring the amount of carbon dioxide a person breathes out or the amount of oxygen they breathe in. For this study, each participant is asked to wear a nose clip and mouthpiece system which is connected to a xygen analyser. The REE is measured after the participants have not eaten for 12 hours (12-hour fasting) and took 15 minutes. Each participant was also assessed for weight loss, how much energy they take in (in the form of food eaten), evidence of body inflammation and malnutrition (by analyzing for certain proteins in the blood) and overall general wellbeing. Overall survival data is also collected.
What are the possible benefits and risks of participating?
Participating in this study has no influence on cancer treatment or care. The data collected are analysed with statistical specific test to explore the impact of resting energy expenditure on cancer malnutrition and survival. A better knowledge of cancer malnutrition could improve both its management and patient’s quality of life.
Where is the study run from?
Cochin Teaching Hospital, Paris (France)
When is the study starting and how long is it expected to run for?
June 2012 to May 2014
Who is funding the study?
Cochin Teaching Hospital, Paris (France)
Who is the main contact?
1. Dr Clara Vazeille
2. Professor François Goldwasser
3. Dr Anne Jouinot
Trial website
Contact information
Type
Public
Primary contact
Dr Clara Vazeille
ORCID ID
Contact details
Medical Oncology
Cochin Teaching Hospital
AP-HP
Paris Descartes University
27 rue du Faubourg Saint Jacques
Paris
75014
France
Type
Public
Additional contact
Prof François Goldwasser
ORCID ID
Contact details
Medical Oncology
Cochin Teaching Hospital
AP-HP
Paris Descartes University
27 rue du Faubourg Saint Jacques
Paris
75014
France
Type
Public
Additional contact
Dr Anne Jouinot
ORCID ID
Contact details
Medical Oncology
Cochin Teaching Hospital
AP-HP
Paris Descartes University
27 rue du Faubourg Saint Jacques
Paris
75014
France
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
041281622
Study information
Scientific title
Relationship between hypermetabolism, cachexia and survival in cancer patients: a prospective study in 390 cancer patients prior to chemotherapy initiation.
Acronym
Study hypothesis
Hypermetabolism is an important determinant of cancer cachexia and thereby have an influence on overall survival
Ethics approval
Cochin institutional review board and local ethics committee, 30/04/2012, ref: CLEC N°041281622.
Study design
Prospective observational cross-sectional and longitudinal study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
No participant information sheet available
Condition
Hypermetabolism, malnutrition and survival in cancer patients.
Intervention
This study involved the measurement of resting energy expenditure by indirect calorimetry using with nose clip and mouthpiece system connected to an oxygen analyser (Fitmate ®, Cosmed, Brignais, France). The measure was performed after a 12-hour fasting and lasted 15 minutes in a resting patient.
Participants were evaluated before systemic treatment initiation including adjuvant chemotherapy. The following parameters were recorded:
1. Weight loss
2. WHO Performance status (PS)
3. C-reactive protein (CRP)
4. Albumin
5. Nutritional Risk index (NRI) =1.519× albumin +41.7×(current weight/usual weight), daily energy intake (DEI), resting energy expenditure (REE) and energy balance
Median follow-up was 15.5 month.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Comparison of weight loss in hypermetabolic patients to weight loss in normometabolic patients.
1. Weight loss is calculated as the percentage of weight lost from healthy condition to the date of recruitment: (recruitment weight-healthy weight)*100/healthy weight.
2. Metabolism is determined by measuring the resting energy expenditure (REE) by indirect calorimetry with nose clip and mouthpiece system connected to an oxygen analyser (Fitmate ®, Cosmed, Brignais, France). Measured REE is compared to calculated REE using revised Harris and Benedict equation: Hm is defined as having measured REE ≥110% of calculated REE, Nm 90 to 110% of calculated REE and hypometabolic patients <90%.
All outcome data was measured on the day of indirect calorimetry .
Secondary outcome measures
Comparison between hypermetabolic and normometabolic patients for:
1. Patient general well-being and activities of daily life, assessed using the WHO performance status
2. C-reactive protein levels, measured using liquid turbidimetry
3. Albumin levels, measured using nephelemetry
4. Nutritional Risk index (NRI)=1.519× albumin +41.7×(current weight/usual weight), daily energy intake , energy balance (=daily energy intakes-Resting Energy expenditure), fat-free mass and overall survival
5. Energy intake, estimated for each patient by an experienced dietician using the 24-hour recall method
6. Fat free mass, measured by evaluation of skeletal muscle tissue cross-sectional area at the third lumbar vertebra on Computed tomography (when images available). Analyses were made with the ImageJ software v1.42q
7. Overall survival, defined as the time between inclusion and death
All outcome data were collected on the day of indirect calorimetry except overall survival (median follow-up 15.5 month).
Overall trial start date
01/06/2012
Overall trial end date
01/05/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Cancer outpatients and inpatients over 18 years. Patients were recruited as they benefit from a routinely evaluation before systemic treatment initiation. We included all cancer patients, any stage, evaluated before systemic treatment initiation including adjuvant chemotherapy.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Patients who were not able to undergo indirect calorimetry (claustrophobia, oxygen therapy, flat nose bridge)
2. Patients who underwent anti-cancer therapy within the previous 30 days.
Recruitment start date
04/06/2012
Recruitment end date
30/04/2016
Locations
Countries of recruitment
France
Trial participating centre
Medical Oncology, Cochin Teaching Hospital, AP-HP, Paris Descartes University
27 rue du Faubourg Saint Jacques
Paris
75014
France
Funders
Funder type
Hospital/treatment centre
Funder name
Cochin Teaching Hospital, Paris (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
American Journal of Clinical Nutrition (re-submission in process)
Intention to publish date
28/09/2017
Participant level data
Available on request
Basic results (scientific)
Publication list