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

NCT05281354 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-10-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier le Mans

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-08-01
Completion
2023-08-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05281354 on ClinicalTrials.gov