Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Other Dietary Supplements

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Omega 3 Fatty Acid

Addition of a treatment to normalise resting energy expenditure according to the observed abnormalities

Treatment to normalise resting energy expenditure according to the observed abnormalities such as anti-inflammatory treatment with Omega 3 in the case of systemic inflammation, treatment with a non-specific beta-blocker such as propanolol in the case of activation of the beta-adrenergic system, appropriate physical activity in the case of sarcopenia, or nutritional support aimed at re-establishing the balance of calorie and protein intake and expenditure, or a combination of these actions

Multimodal intervention

Christelle JADEAU

François GOLDWASSER, PHD

François Goldwasser, PHD

Pascaline BOUDOU-ROUQUETTE, MD

Half of all cancer patients show an increase in resting energy expenditure. The causes of hypermetabolism have only recently been investigated in cancerology. One established cause is inflammation, but other causes have yet to be identified.

The interest in hypermetabolism is due to the fact that it appears early, before the onset of clinical deterioration (weight loss, sarcopenia, altered performance status) and that it correlates with patient morbidity and mortality. Like the other parameters that make up cachexia, it is both a predictor of toxicity and reduced efficacy of anti-tumour treatments and a prognostic factor, regardless of the tumour.

A therapeutic goal is to correct hypermetabolism for two reasons:

* avoid progression to clinical cachexia, which is an independent cause of morbidity and mortality
* increase the efficacy of anti-PD1/PDL1 immunotherapies. This new class of therapy has revolutionised the therapeutic management of many cancers but is less effective in cases of inflammation and/or altered performance status and/or hypermetabolism.

Investigator hypothesises that it is possible to develop a patient-specific treatment to correct hypermetabolism, depending on the predominant clinical or biological cause.

Development of a Personalised Therapeutic Approach for Cancer Patients With Resting Hypermetabolism

The impact of a multimodal intervention is evaluated by proportion of hypermetabolic patients at 1 month in the personalised multimodal intervention arm compared to patients in the standard care arm

Centre Hospitalier le Mans

Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Fluorodeoxyglucose F18

questionnary on predictif factors about physiological hypermetabolism of anal canal

questionnary

Questionnaire to be completed by patients coming for PET to identify the predictive factors of physiological hypermetabolism of the anal canal

Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT

Confrontation in participants of hypermetabolism of the anal canal in PET with:

number of stool/day and consistency of stool, medical history (by Answers to the specific questionnaire designed for the study)

Visual analysis of hypermetabolism of the anal canal on a 3-point scale:

0: no hypermetabolism

1. moderate hypermetabolism
2. intense hypermetabolism

measurement of the largest rectal diameter in mm.

Visual assessment of the rectal capacity on a 3-point scale (0, 1, 2) and content characteristics (air, feces, air and feces).

Centre Francois Baclesse

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients with non-small cell lung carcinoma younger than 75y

Patients with non-small cell lung carcinoma aged 75 or more

Aging and cancer are two conditions associated with extensive metabolic changes that can cause malnutrition. However, the clinical features and the underlying mechanisms leading to malnutrition are different in these two cases. We therefore wonder how age can influence the metabolic response to cancer.

During aging, among other physiological modifications, inactivity and insulin resistance cause a progressive muscle loss associated with a decrease in resting energy expenditure (REE). In cancer, loud inflammation background also provokes a decrease in muscle mass as well as in fat mass. However, previous studies reported an increased REE, termed hypermetabolism, probably linked to inflammation.

Data concerning response to aggression in the elderly patient is scarce and even inexistent when it comes to cancer. The investigators hypothesize that the mitochondrial dysfunction that comes with aging and that decreases the ATP rendering per unit of energy-producing nutrient oxidized increases the amount of nutrient to be consumed in order to sustain to energy needs. Therefore, in this situation, elderly patients could have a higher rate or degree of hypermetabolism than younger patients.

The primary objective of this study is to assess the effect of aging on the metabolic response to cancer assessed by resting energy expenditure measured by indirect calorimetry corrected by whole body fat free mass calculated from single slice CT imaging at the third lumbar vertebra.

The secondary objective of this study is to point out some inflammatory or endocrine determinants of these energy metabolism changes in the cancer patient.

Non-small cell lung carcinoma seems to be a relevant choice for this study because it is frequently associated with cachexia and the literature reports a high rate of hypermetabolism in this cancer.

Hypermetabolism in the Elderly Lung Cancer Patient

Energy expenditure is measured by indirect calorimetry.

Aggregates blood Insulin and glucose level as an insulin resistance score

Estimated from muscular area at the third lombular vertebra from CT-scan

REE estimated with Harris \& Benedict Formula

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Development of a Personalised Therapeutic Approach for Cancer Patients With Resting Hypermetabolism	NCT05281354	Cancer	Multimodal inte...	18 Years -	Centre Hospitalier le Mans
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT	NCT03506529	Anal Cancer	questionnary	18 Years -	Centre Francois Baclesse
Hypermetabolism in the Elderly Lung Cancer Patient	NCT03141957	Non-small Cell ...		18 Years - 95 Years	University of Paris 5 - Rene Descartes
Identification of Predictive Factors for Physiological Hypermetabolism of the Anal Canal in 18F-FDG PET / CT	NCT03506529	Anal Cancer	questionnary	18 Years -	Centre Francois Baclesse
Hypermetabolism in the Elderly Lung Cancer Patient	NCT03141957	Non-small Cell ...		18 Years - 95 Years	University of Paris 5 - Rene Descartes

Spots Global Cancer Trial Database for hypermetabolism