Safety

Overall, the treatment was quite well tolerated by patients. No patient complained of serious adverse events nor was withdrawn from the study due to toxicity. One patient interrupted MPA after 2

Table 2. Nutritional/functional and laboratory variables evaluated after 1,2, and 4 months of treatment on 39 patients

Variable

Baseline

After 1 month

P

After 2 months

P

After 4 months

P

value

value

value

Body weight (kg)

55.1 ± 10

56.5 ± 10.5

0.001

56.4 ± 9.7

0.036

57 ± 9.8

0.031

LBM (kg)

38 ± 9

38.9 ± 9

0.059

39.4 ± 8.9

0.045

39.7 ± 8.7

0.024

Grip strength (kg)

28.0 ± 10.4

27.8 ± 9.5

0.879

27.9 ± 9.3

0.673

28.1 ± 9.5

0.827

Appetite

5.5 ± 2.5

6.6 ± 2.2

0.005

6.8 ± 1.9

0.001

7.0 ± 1.6

0.004

IL-6 (pg/ml)

12.5 ± 9.9

8.8 ± 8.7

0.002

7.5 ± 8.6

0.003

7.4 ± 8.5

0.007

TNFa (pg/ml)

22.2 ± 16.6

19.5 ± 16

0.204

15.8 ± 13

0.020

14 ± 11.7

0.015

Leptin (ng/ml)

5.9 ± 6.1

8.9 ± 10.6

0.008

10.2 ± 13.3

0.031

13.6 ± 13.3

<

0.001

ROS (FORT U)

468.5 ± 97.2

436.6 ± 92.5

0.033

437.7 ± 89.6

0.087

444.1 ± 93.6

0.162

GPx (U/l)

8206.6 ± 2322.3

8339.3 ± 2411.8

0.726

8295.9 ± 2314.1

0.848

8849.2 ± 2629

0.211

Data are reported as mean ± standard deviation. Significance was considered for p < 0.05, as calculated with Student's t test for paired data (post-treatment values vs baseline values). Significance for IL-6, TNF-a and leptin was calculated using Wilcoxon ranks test. LBM, lean body mass; IL-6, interleukin-6; TNF-a, tumour necrosis factor-a; ROS, reactive oxygen species; GPx, glutathione peroxidase

Data are reported as mean ± standard deviation. Significance was considered for p < 0.05, as calculated with Student's t test for paired data (post-treatment values vs baseline values). Significance for IL-6, TNF-a and leptin was calculated using Wilcoxon ranks test. LBM, lean body mass; IL-6, interleukin-6; TNF-a, tumour necrosis factor-a; ROS, reactive oxygen species; GPx, glutathione peroxidase

Fig. 1. Body weight and LBM values after 1, 2 and 4 months of treatment compared to baseline. The body weight and LBM are shown in kilograms (kg). * p < 0.01; ** p < 0.05, as calculated by Student's t-test for paired data (post-treatment data versus baseline)

5 0 -

** **

□ Leptin

*

**

**

*

*

*

Baseline 1 month 2 months 4 months

Baseline 1 month 2 months 4 months

Fig. 2. Serum levels of TNF-a (pg/ml), IL-6 (pg/ml) and leptin (ng/ml) after 1, 2 and 4 months of treatment compared to baseline. * p < 0.01; ** p < 0.05, as calculated by Wilcoxon ranks test (post-treatment data versus baseline)

1000

B

onth 2 m<

□ ROS (Fort U)

Fig. 3. Blood levels of GPx and ROS after 1, 2 and 4 months of treatment compared to baseline. n.s., non-significant, as calculated by Student's t-test for paired data (post-treatment data versus baseline)

Table 3. Quality of life variables assessed after 1,2 and 4 months of treatment in 39 patients

Questionnaire

Baseline

After 1 month

p value

After 2 month

p value

After 4 month

p value

EORTC QLQ-C30

65.9 ± 16.3

72.4 ± 15.6

0.008

71.8 ± 14.6

0.020

70.9 ± 14.6

0.044

EQ-5Dindex

0.50 ± 0.4

0.58 ± 0.4

0.175

0.56 ± 0.4

0.340

0.59 ± 0.4

0.114

EQ-5Dvas

49.4 ± 21.4

58.9 ± 22.7

0.016

58.6 ± 20.6

0.015

58.7 ± 19.4

0.009

MFSI-SF

20.1 ± 22.1

14.4 ± 20.3

0.125

11.8 ± 17.2

0.022

10.8 ± 14.4

0.004

The global QL score for each questionnaire is reported as mean ± SD. For EORTC QLQ-C30, EQ5Dindex and EQ-5Dvas the increasing score corresponds to improvement of quality of life, while for MSFI-SF the decrease of QL score corresponds to amelioration of fatigue. Significance was considered at p < 0.05, as calculated with Student's t test for paired data (post-treatment values vs baseline). EORTC QLQ-C30, European Organization for Research and Treatment of Cancer QLQ-C30; EQ-5D, Euro QL-5D, MFSI-SF Multidimensional Fatigue Symptom Inventory-Short Form

Table 4. Correlation between LBM changes and changes of clinical (ECOG PS), nutritional/functional (appetite, grip strength), laboratory (IL-6, TNF-a, leptin, ROS, GPx) and quality of life variables

Spearman's r p value

Clinical variables

Nutritional/functional variables

Appetite 0.08 0.664

Grip strength 0.01 0.949

Laboratory variables

Leptin 0.26 0.121

ROS 0.11 0.529

GPx 0.05 0.747

QL questionnaires

EORTC QLQ-C30 0.17 0.303

EQ-5Dindex 0.02 0.913

EQ-5Dvas 0.28 0.097

MFSI-SF 0.21 0.271

The results show a significant correlation between LBM changes and IL-6 levels. In contrast, the changes of other variables did not show a significant correlation with LBM changes. Correlation analysis was performed by Spearman rank correlation test. Results were considered significant at p < 0.05. ECOG PS, Eastern Cooperative Oncology Group Performance Status; IL-6, interleukin-6; TNF-a, tumour necrosis factor-a; ROS, reactive oxygen species; GPx, glutathione peroxidase; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer QLQ-C30; EQ-5D, Euro QL-5D; MFSI-SF, Multidimensional Fatigue Symptom Inventory-Short Form

Table 5. Correlation between MFSI-SF score changes and changes of clinical (ECOG PS), nutritional/functional (LBM, appetite, grip strength) and laboratory (IL-6, TNF-a, leptin, ROS, GPx) variables

Spearman's r p value

Clinical variables

ECOG PS 0.10 0.582

Nutritional/functional variables LBM 0.21 0.271

Appetite -0.16 0.410

Grip strength -0.22 0.276

Laboratory variables

Leptin -0.10 0.622

ROS 0.31 0.103

Correlation analysis was performed by Spearman rank correlation test. Results were considered significant at p < 0.05. ECOG PS, Eastern Cooperative Oncology Group Performance Status; LBM, lean body mass; IL-6, interleu-kin-6; TNF-a, tumour necrosis factor-a; ROS, reactive oxygen species; GPx, glutathione peroxidase months because of deep-vein thrombosis in the leg. So far, the treatment has been demonstrated to be safe without significant side-effects and achieved an optimal compliance by patients as assessed by count of both tablets/cans returned.

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