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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: Multimodal intervention

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François GOLDWASSER, PHD; Phone Number: +33243434343; Email: fgoldwasser@ch-lemans.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • Centre Hospitalier du Mans
    • Principal Investigator: François Goldwasser, PHD
  • Paris, France, 75000
    • Not yet recruiting
    • Hôpital Cochin
    • Contact: Pascaline BOUDOU-ROUQUETTE, MD; Phone Number: +33158411746; Email: pascaline.boudou@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier le Mans

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Hypermetabolism; Rest Energy Expenditure
• Other Study ID Numbers: CHM-2021/S13/12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No