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

ClinicalTrials.gov ID

NCT05281354

Lead Sponsor

Centre Hospitalier le MansOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Oct 28, 2022Actual

Start Date

Dec 1, 2022Estimated

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Aug 1, 2023Estimated

Official Title

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

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.

• Cancer

• Multimodal intervention

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Hospitalier le MansOTHER

pascaline.boudou@aphp.fr+33158411746

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