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

Cancer Clinical Trial

— METABO-1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281354
• Other study ID #: CHM-2021/S13/12
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: +33244710781
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Du Mans	Le Mans
France	Hôpital COCHIN	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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