Focus on the assessment of physical activity level of patients with cancer cachexia enrolled in a randomized phase III clinical trial.

Abstract

9164 Background: Physical activity is an important component of the physical and social domains of quality of life (QL); therefore any restoration of physical activity level (PAL) towards a normal level may translate into an improvement in QL of cachectic cancer patients. Purpose: We carried out a phase III randomized study to establish which was the most effective and safest treatment to improve the primary endpoints of cancer cachexia and among them we have selected as the most relevant PAL. Patient total daily PAL and associated energy expenditure was assessed with an electronic device (SenseWear PRO2 Armband), shown in some validation studies to be able to assess appropriately the total energy expenditure (TEE) and its specific components, resting energy expenditure (REE) and active energy expenditure (AEE). AEE was recorded at an intensity ≥ 3.0 metabolic equivalents corresponding to a moderate physical activity. The armband is able to identify the specific type of patient physical activity in such a way to attribute to it a “functional quality.” Methods: Seventy out of 332 patients with cancer cachexia enrolled in the study were assessed for total daily PAL before and after treatment. The study design planned to randomly assign eligible patients to 1 of 5 arms of treatment: 1) medroxyprogesterone 500 mg/d or megestrol acetate 320 mg/d; 2) oral supplementation with 2 g EPA; 3) L-carnitine 4 g/d; 4) thalidomide 200 mg/d; 5) a combination of the above. Treatment duration: 4 months. Results: Total daily PAL showed that TEE and AEE increased significantly in arm 5 (TEE from 1291 kcal/die to 1649 kcal/die, p=0.04 and AEE from 93.8 kcal/die to 155 kcal/die, p=0.032) with a concomitant significant decrease of REE (from 1227 ± 439 to 1067 ± 181 kcal/die, p=0.044). The primary endpoints LBM (by DEXA) and fatigue improved significantly in arm 5. Toxicity was substantially negligible, comparable between treatment arms. Conclusions: The present study showed that the combination regimen was the only effective treatment in improving patient total daily PAL. Our trial shows that PAL monitoring provides a new dimension in the assessment of the comprehensive quality of life of cachectic cancer patients. No significant financial relationships to disclose.