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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: François GOLDWASSER, PHD
- Phone Number: +33243434343
- Email: fgoldwasser@ch-lemans.fr
Study Locations
-
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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
|
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
Time Frame: 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
|
1 month after inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHM-2021/S13/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.