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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Multimodal intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patient with solid malignancy (any possible primary tumor), stage IV (M1), progressive or stable Without treatment or with anti-tumour treatment WHO performance status ≤ 2 Person affiliated or benefiting from a social security scheme Having signed a consent to participate in the study Patient with hypermetabolism at the inclusion visit Exclusion Criteria: Patient agitated, or unable to understand or tolerate wearing a mask for 20 minutes No active tumour disease (complete remission or ongoing tumour response) Care plan that does not allow for two calorimetry sessions 1 month apart Pregnant, breastfeeding or parturient woman Person deprived of liberty by judicial or administrative decision Person subject to forced psychiatric care Person subject to a legal protection measure Inclusion in another interventional study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>Follow-up according to standard practice | |
| Experimental: multimodal intervention<br>Addition of a treatment to normalise resting energy expenditure according to the observed abnormalities | Other: Multimodal intervention<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact at 1 month of a multimodal intervention on hypermetabolism in cancer patients compared to standard care | 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 | 1 month after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypermetabolism, Rest Energy Expenditure, Cancer