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

NCT ID: NCT05281354

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2023-08-01

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

standard care

Follow-up according to standard practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

multimodal intervention

Addition of a treatment to normalise resting energy expenditure according to the observed abnormalities

Group Type: EXPERIMENTAL

Multimodal intervention

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Du Mans

Le Mans, , France

Site Status: RECRUITING

Hôpital COCHIN

Paris, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Christelle JADEAU

Role: CONTACT

cjadeau@ch-lemans.fr

+33244710781

François GOLDWASSER, PHD

Role: CONTACT

fgoldwasser@ch-lemans.fr

+33243434343

Facility Contacts

Christelle JADEAU

Role: primary

cjadeau@ch-lemans.fr

+33244710781

Pascaline BOUDOU-ROUQUETTE, MD

Role: primary

pascaline.boudou@aphp.fr

+33158411746

Other Identifiers

CHM-2021/S13/12

Identifier Type: -

Identifier Source: org_study_id