METABO-1: Development of a Personalised Therapeutic Approach for Cancer Patients With Resting Hypermetabolism
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: standard care Follow-up according to standard practice |
|
| Experimental: multimodal intervention Addition of a treatment to normalise resting energy expenditure according to the observed abnormalities |
Other: Multimodal intervention
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
|
Outcome Measures
Primary Outcome Measures
- Assess the impact at 1 month of a multimodal intervention on hypermetabolism in cancer patients compared to standard care [1 month after inclusion]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Du Mans | Le Mans | France | 72000 | |
| 2 | Hôpital COCHIN | Paris | France | 75000 |
Sponsors and Collaborators
- Centre Hospitalier le Mans
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHM-2021/S13/12