Effect of combined therapies including nutrition and physical exercise in advanced cancer patients: A pooled analysis.

Background and aims: Although many cancer patients suffer from malnutrition or cancer cachexia, there is no standard of care so far due to limited intervention trials. Pooled data from two combined trials were analyzed regarding nutritional status and survival time. Materials and methods: Data from two trials with advanced cancer patients were included. In both trials, patients in the intervention group received at least three times nutritional counseling and supervised training sessions. Patients in the control group continued being treated according to usual care. Nutritional status was measured using BMI, body composition and handgrip strength. Survival time was analyzed using the Cox proportional hazard model with the period between the beginning of the trial and death as underlying time scale. Results: 68 men (61.8%) and 42 women (38.2%) were randomized either to the intervention (n = 56) or the control (n = 54) group. The inter-group difference for changes in BMI and body composition was not statistically significant after 3 months. Handgrip strength improved significantly from 34.4 ± 10.2 kg to 36.3 ± 9.9 kg at 3 months in the intervention compared to 33.9 ± 9.2 kg to 34.9 ± 9.1 kg in the control group (p = 0.006). The analysis of survival time showed no inter-group difference for all patients. A detailed analysis for different diagnoses showed that in patients with lung cancer, the covariates "CRP value," "days from first diagnosis to randomization" as well as "gender" were significantly associated with survival time. Patients with higher CRP value had a shorter survival time and female patients had a shorter survival time than male patients in our analysis. In addition, patients with pancreatic cancer randomized to the control group had a 20% shorter survival time than those in the intervention group (p = 0.048). Conclusion: The pooled analysis showed a significant improvement of handgrip strength in advanced cancer patients through the implementation of a combined therapy. Handgrip strength is of prognostic significance in hospitalized patients due to its association with mortality and morbidity. However, no improvements in further tests were detected. There is great need for further investigations examining the effect of nutritional and exercise therapy on survival time with focus on different cancer diagnoses.

Results from an Epidemiological Follow-Up Survey on Home Artificial Nutrition in Switzerland from 2010 to 2015.

BACKGROUND: Home artificial nutrition (HAN) is an established treatment for malnourished patients. Since July 2012, the costs for oral nutrition supplements (ONS) are covered by the compulsory health insurance providers in Switzerland if the patient has a medical indication based on the Swiss Society for Clinical Nutrition guidelines. Therefore, the purpose of our study was to analyse the development of HAN, including ONS, before and after July 2012. METHODS: We obtained the retrospective and anonymized data from the Swiss association for joint tasks of health insurers (SVK), who registered patients on HAN. Since not all health insurers are working with SVK, this retrospective study recorded nearly 65% of all new patients on HAN in Switzerland from January 1, 2010, to December 31, 2015. RESULTS: A total of 33,410 patients (49.1% men and 50.9% women) with a mean BMI of 21.3 ± 4.5 kg/m2 and mean age of 68.9 ± 17.8 years were recorded. The number of patient cases on ONS increased from 808 cases in 2010 to 18,538 cases in 2015, while patient cases on home enteral nutrition (HEN) and home parenteral nutrition (HPN) remained approximately the same. The relative distribution of type of HAN changed from 26.2% cases on ONS, 68.7% cases on HEN and 5.1% cases on HPN in 2010 to 86.1% cases on ONS, 12.8% cases on HEN, and 1.1% cases on HPN in 2015. Treatment duration decreased for ONS from 698 ± 637 days to 171 ± 274 days, for HEN from 416 ± 553 days to 262 ± 459 days, and for HPN from 96 ± 206 days to 72 ± 123 days. Mean costs per patient decreased for ONS from 1,330 CHF in 2010 to 606 CHF in 2015. Total costs for HAN increased from 16,895,373 CHF in 2010 to 32,868,361 CHF in 2015. CONCLUSION: Our epidemiological follow-up study showed an immense increase in number of patients on HAN in Switzerland after July 2012. Due to shorter therapy duration and reduced mean costs per patient, total costs were only doubled while the number of patients increased 7-fold.

Effect of a leucine-rich supplement in combination with nutrition and physical exercise in advanced cancer patients: A randomized controlled intervention trial.

BACKGROUND & AIMS: Branched-chain amino acids and specifically leucine stimulate protein synthesis and may overcome an anabolic resistance in malnourished and cachectic cancer patients. Therefore, we hypothesized that the addition of a leucine-rich supplement to a multimodal therapy improves physical function in advanced cancer patients. METHODS: This single center, randomized trial examined a multimodal therapy over 12 weeks in patients with advanced cancer. The intervention group received a leucine-rich supplement in combination with a nutrition and physical exercise program. Patients in the control group received standard care. Primary endpoint was physical function measured with the short physical performance battery (SPPB). Secondary endpoints were further physical performance tests, nutritional status, dietary intake, fatigue, quality of life (QoL) and clinical course. All parameters were evaluated at baseline, after three and at six months. RESULTS: 23 women and 29 men with an average age of 63.1 ± 10.3 (range 30-81) years and BMI of 25.4 ± 4.7 kg/m2 were randomized either to the intervention (n = 27) or control (n = 25) group. Patients in the intervention group joined a mean of 28.4 ± 7.4 training sessions (78.8%), 3.2 ± 0.6 nutritional counselling sessions (106.7%) and consumed on average 85.4 ± 33.2 supplements (71.2%). Inter-group comparison showed no significant difference in the primary endpoint SPPB after three (p = 0.184, 95% CI: -1.43, 0.29) and six months (p = 0.986, 95% CI: -0.87, 0.89). However, the secondary endpoint handgrip strength improved significantly from 35.8 ± 9.8 kg at baseline to 37.6 ± 10.0 kg at three months in the intervention group compared to 35.7 ± 8.8 kg at baseline to 34.0 ± 10.1 kg at three months in the control group (p < 0.001, 95% CI: -6.03, -1.97). The inter-group difference for changes in the further secondary endpoints nutritional status, dietary intake, fatigue, QoL and clinical course showed a trend towards an improvement in the intervention group, however, the differences were not significant after three and six months. CONCLUSIONS: The present trial demonstrated a good adherence to the multimodal therapy as well as a significant improvement of handgrip strength in patients with advanced cancer. In addition, the clinical course data underlined the safety of the program. However, we failed to show significant improvements in further physical performance tests, especially our primary outcome factor SPPB as well as nutritional status, fatigue or QoL.

Effects of nutrition and physical exercise intervention in palliative cancer patients: A randomized controlled trial.

BACKGROUND & AIMS: Cancer cachexia is multifactorial and should be targeted using a multimodal form of intervention. The purpose of the present trial was to test the effects of a combined nutrition and physical exercise program on cancer patients with metastatic or locally advanced tumors of the gastrointestinal and lung tracts. METHODS: Patients were randomized into two groups: One group received a minimum of three standardized individual nutritional counselling sessions and participated in a 60-min exercise program twice a week. The second group received their usual care. The intervention spanned a period of three months. Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0), physical performance (hand-grip strength, 6-min walk test, timed sit-to-stand test and 1 repetition maximum leg press), nutritional status (body weight, bioelectrical impedance analysis), dietary intake (three-day dietary record) and clinical data (unexpected hospital days, performance status) were tested at baseline and after three and six months. RESULTS: In total, 18 women and 40 men (mean age 63, range 32-81) with metastatic or locally advanced tumors of the gastrointestinal (n = 38) and lung (n = 20) tracts were included. Median adherence to the supervised exercise program was 75%. The median number of individual nutritional counselling sessions was 3.0 (range 0-7 sessions). Post intervention, no difference in global health status/quality of life (overall QoL) was observed. Intervention was superior to UC for the patient-rated symptom scale regarding nausea and vomiting (p = 0.023) and protein intake (p = 0.01). No statistical differences were observed for energy intake, nutritional status and physical performance. CONCLUSIONS: The results show good adherence to a combined nutrition and exercise program. The multimodal intervention did not improve overall QoL, but contributed to an adequate protein intake and to the general well-being of the patient by reducing nausea and vomiting.

Influence of a nutritional intervention on dietary intake and quality of life in cancer patients: a randomized controlled trial.

OBJECTIVE: Weight loss is common in patients with malignant tumors and it can adversely affect quality of life and survival. The aim of the present study was to investigate the effects of a nutritional intervention in cancer patients in an outpatient setting. METHODS: Cancer outpatients (N = 58) who were classified as undernourished or at high risk for undernutrition by the Nutritional Risk Screening 2002 tool were randomized into two groups. One group (n = 30) received standardized individual nutritional therapy, including counseling by a dietitian, food fortification, and oral nutritional supplements if required. The second group (n = 28) received standard care. The nutritional intervention lasted 3 mo. Dietary intake (3-d dietary record), nutritional status (body weight), physical functioning (performance status, hand-grip strength) and quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0) were assessed at baseline and after 6 wk and 3 mo. An additional follow-up assessment was carried out 3 mo post-intervention. RESULTS: Nutritional intervention led to a significantly higher average energy and protein intake in the nutritional therapy group (+379 kcal; 95% confidence interval [CI], 117-642; P = 0.007, respectively; +10.4 g; 95% CI, 2.3-18.5; P = 0.016). However, the increased dietary intake was not associated with improvements in nutritional status, physical functioning, or quality of life. CONCLUSIONS: Individual nutritional counseling significantly and positively influenced energy and protein intake, but did not improve nutritional or physical outcome or quality of life. These results indicate that nutritional therapy alone is of limited efficacy in cancer patients whose nutritional status has already deteriorated.