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

NCT05281354 | Unknown

• 1 other identifier: CHM-2021/S13/12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Keywords

Hypermetabolism; Rest Energy Expenditure; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

standard care

NO INTERVENTION

Follow-up according to standard practice

multimodal intervention

EXPERIMENTAL

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

Other: Multimodal intervention

Interventions

Multimodal intervention 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

multimodal intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (2)

Centre Hospitalier Du Mans

Le Mans, 72000, France

RECRUITING

Hôpital COCHIN

Paris, 75000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Christelle JADEAU

CONTACT

+33244710781; cjadeau@ch-lemans.fr

François GOLDWASSER, PHD

CONTACT

+33243434343; fgoldwasser@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-03

Locations

FR (2)