Development of a Personalised Therapeutic Approach for Cancer Patients With Resting Hypermetabolism
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Assess the impact at 1 month of a multimodal intervention on hypermetabolism in cancer patients compared to standard care
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assess the impact at 1 month of a multimodal intervention on hypermetabolism in cancer patients compared to standard care
时间窗: 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
次要结局
未报告次要终点