Development of a Personalised Therapeutic Approach for Cancer Patients With Resting Hypermetabolism (METABO-1)

Centre Hospitalier le Mans

Status

Unknown

Conditions

Cancer

Treatments

Other: Multimodal intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05281354

CHM-2021/S13/12

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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