Physical Activity as a Primary Patient Centred Outcome in Cachexia Intervention Trials

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Many cachexia intervention trials have focused solely on changes in nutritional status as the primary end-point. However, regulatory authorities are also interested in improving patients' QoL [4]. An important domain of QoL that may be strongly influenced by nutritional status is physical function. To improve physical activity in cancer cachexia, a number of areas may be targeted (Fig. 6). LBM (the patient's 'engine') may be maximised either by size and/or by the efficiency of its func tion. Food intake (the patient's 'fuel') may be maximised by increasing the total supply of macronu-trients (more calories) and/or improving the energy quality/density of the food. Finally, medical, nursing or physiotherapy staff may attempt to

Table 2. Nutritional and functional patient characteristics (n = 170), according to a multifactor definition of cancer cachexia

Cachexia definition (all three criteria met)

> 10 mg/l CRP

No (n = 133)

Yes (n = 37)

p value

Body composition Lean body mass (kg)

44.3

39.6

0.003

Objective function

Grip strength (kg2) KPS

27.9 76.3

22 67

< 0.001 < 0.001

Health status

EQ-5DVas

58.9

43

< 0.001

Subjective function

EORTC: Physical function EORTC: Dyspnoea EORTC: Fatigue

69.1

17.2 47.7

53.3 35.1 69.1

< 0.001 0.001 < 0.001

Patients were required to fulfil all three criteria (weight loss, dietary intake, elevated C-reactive protein [CRP]) of the multifactor cachexia definition, and were studied for differences in body composition and objective and subjective indices of functional status. KPS, Karnofsky performance score; EQ-5Dvas, visual analogue scale rating of EQ-5D health-related quality-of-life questionnaire; EORTC, the European Organization for Research and Treatment of Cancer questionnaire

Patients were required to fulfil all three criteria (weight loss, dietary intake, elevated C-reactive protein [CRP]) of the multifactor cachexia definition, and were studied for differences in body composition and objective and subjective indices of functional status. KPS, Karnofsky performance score; EQ-5Dvas, visual analogue scale rating of EQ-5D health-related quality-of-life questionnaire; EORTC, the European Organization for Research and Treatment of Cancer questionnaire

• Systemic inflammation (CRP>10 mg/l)

Fig. 5. Key markers of cachexia. CRP, C-reactive protein

Fig. 6. Improving physical activity in cancer cachexia. LBM,lean body mass; PAL, physical activity level t Size t Efficiency t Supply t Quality t Motivation t Efficiency

PAL t motivate the cachectic patient to mobilise, or instruct the patient on how to utilise their limited energy reserves more efficiently.

In a recent intervention trial, Moses and coworkers demonstrated that the baseline PAL of cachectic pancreatic cancer patients was very low (with patients spending prolonged periods at rest or in bed) [49]. Patients were randomised to receive either an energy- and protein-dense oral nutritional supplement, or the same supplement enriched with a pharmacological dose of EPA. The combined regimen was designed not only to improve patients' food intake but also to address some of the underlying metabolic abnormalities that contribute to the syndrome of cachexia (e.g. systemic inflammation). Patients receiving the conventional supplement did not demonstrate increased PAL. However, PAL did increase significantly in those patients receiving the combined regimen, to values commensurate for sedentary office workers [67]. This is one of the few randomised studies that has used objective methodology and shown that a nutritional intervention can improve physical function in advanced cancer patients.

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