Predicting acute severe toxicity for head and neck squamous cell carcinomas by combining dosimetry with a radiosensitivity biomarker: a pilot study.

OBJECTIVE: Radiotherapy (RT) against head and neck squamous cell carcinomas (HNSCC) may lead to severe toxicity in 30-40% of patients. The normal tissue complication probability (NTCP) models, based on dosimetric data refined the normal tissue dose/volume tolerance guidelines. In parallel, the radiation-induced nucleoshuttling (RIANS) of the Ataxia-Telangiectasia Mutated protein (pATM) is a predictive approach of individual intrinsic radiosensitivity. Here, we combined NTCP with RADIODTECT©, a blood assay derived from the RIANS model, to predict RT toxicity in HNSCC patients. METHODS: RADIODTECT© cutoff values (i.e. 57.8 ng/mL for grade⩾2 toxicity and 46 ng/mL for grade⩾3 toxicity) have been previously assessed. Validation was performed on a prospective cohort of 36 HNSCC patients treated with postoperative RT. Toxicity was graded with the Common Terminology Criteria for Adverse Events (CTCAE) scale and two criteria were considered: grade⩾2 oral mucositis (OM2), grade⩾3 mucositis (OM3) and grade⩾2 dysphagia (DY2), grade⩾3 dysphagia (DY3). pATM quantification was assessed in lymphocytes of HNSCC patients. The discrimination power of the pATM assay was evaluated through the Area Under the Receiver Operator Characteristics Curve (AUC-ROC). Two previously described NTCP models were considered, including the dose to the oral cavity and the mean dose to the parotid glands (OM2 and OM3) and the dose to the oral cavity, to the larynx and the volume of pharyngeal constrictor muscles (DY2 and DY3). RESULTS: Combining NTCP models with RADIODTECT© blood test improved the AUC-ROC. Considering the prediction of mucositis, AUC-ROCNTCP+RADIODTECT©=0.80 was for OM2, and AUC-ROCNTCP+RADIODTECT©=0.78 for OM3. Considering the prediction of acute dysphagia, AUC-ROCNTCP+RADIODTECT©=0.71 for DY2 and for DY3. CONCLUSIONS: Combining NTCP models with a radiosensitivity biomarker might significantly improve the prediction of toxicities for HNSCC patients.

ESPEN practical guideline: Clinical Nutrition in cancer.

BACKGROUND: This practical guideline is based on the current scientific ESPEN guidelines on nutrition in cancer patients. METHODS: ESPEN guidelines have been shortened and transformed into flow charts for easier use in clinical practice. The practical guideline is dedicated to all professionals including physicians, dieticians, nutritionists and nurses working with patients with cancer. RESULTS: A total of 43 recommendations are presented with short commentaries for the nutritional and metabolic management of patients with neoplastic diseases. The disease-related recommendations are preceded by general recommendations on the diagnostics of nutritional status in cancer patients. CONCLUSION: This practical guideline gives guidance to health care providers involved in the management of cancer patients to offer optimal nutritional care.

Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial.

PURPOSE: Exercise has been shown to improve physical and psychological conditions during cancer therapy, but mechanisms remain poorly understood. The purpose of the present study was to report the results of cancer-related biomarkers and metabolomics outcomes from the PASAPAS feasibility study. METHODS: In the PASAPAS randomized controlled trial, 61 women beginning adjuvant chemotherapy for localized breast cancer were randomized in a 6-month program of weekly aerobic exercises associated with nutritional counseling versus usual care with nutritional counseling. In the present analysis of 58 women for whom blood samples were available, first, circulating levels of biomarkers (ie, insulin, insulin-like growth factor 1, estradiol, adiponectin, leptin, interleukin-6, and tumor necrosis factor α) were measured at baseline and 6-month follow-up. Changes in biomarkers were compared between exercisers (n = 40) and controls (n = 18) using mixed-effect models. Second, serum metabolites were studied using an untargeted 1H nuclear magnetic resonance spectroscopy, and orthogonal partial least squares analyses were performed to discriminate exercisers and controls at baseline and at 6 months. RESULTS: Over the 6-month intervention, no statistically significant differences were observed between exercisers and controls regarding changes in biomarkers and metabolomic profiles. CONCLUSION: The present analysis of the PASAPAS feasibility trial did not reveal any improvement in circulating biomarkers nor identified metabolic signatures in exercisers versus controls during adjuvant breast cancer treatment. Larger studies preferably in women with poor physical activity level to avoid ceiling effect, testing different doses and types of exercise on additional biological pathways, could allow to clarify the mechanisms mediating beneficial effects of physical exercise during cancer treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01331772. Registered 8 April 2011, https://clinicaltrials.gov/ct2/show/NCT01331772?term=pasapas&rank=1.

[Effect of activities profile variations on health-related quality of life among breast cancer patients: Secondary exploratory analysis from PASAPAS study data]. / Effet de l'évolution du profil d'activité quotidienne sur la qualité de vie chez des femmes atteintes de cancers du sein : analyse exploratoire secondaire des données de l'étude PASAPAS.

INTRODUCTION: Lifestyle changes in breast cancer patients, by physical activity increasing, are becoming a main objective in supportive care. The objective of this study was to explore the impact of the daily activity profile evolution on the quality of life among this public. METHODS: Sixty patients (18 to 75 years) with non-metastatic breast cancer were randomized to a 2:1 ratio (physical activity intervention; control) in the PASAPAS randomized clinical trial. Multiple linear regression analyzes were computed to explain quality of life scores 6 months after the start of adjuvant therapy. Variables retained were the baseline quality of life scores, the anxiety trait, the randomization arm, the variations of time spent in different physical activity classes ([3-4 [MET, [4-6 [MET, ≥6 MET) and in sedentary behaviors. RESULTS: Only the decrease in time spent in sedentary behaviors really appeared as a predictor of the quality of physical life. Participation in the intervention group appeared as a predictor of quality of mental life. DISCUSSION: Results plead in favor of sedentary life style decrease as part of the objectives of care program for women with breast cancer. It also highlights the need of collective supervised sessions implemented by competent staff. This research also suggests that the dynamics of daily activity profile variations should be studied further in association to quality of life.

Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial.

We undertook a cost-effectiveness analysis (CEA) to compare an exercise and nutritional program with the usual nutritional care concomitant to adjuvant chemotherapy in localized breast cancer patients. The CEA was designed as part of the interventional, controlled, randomized, single-center, open-label PASAPAS study. Breast cancer patients receiving first-line adjuvant chemotherapy at a French Comprehensive Cancer Center were randomized 2:1 to a 6-month exercise program of supervised indoor and outdoor group sessions in addition to usual nutritional care (exercise arm) or a usual nutritional care group receiving dietary and physical activity counseling (control arm). Costs were assessed from the French national insurance perspective (in Euros, 2012). Incremental cost-effectiveness ratios (ICERs) were calculated for four criteria: body mass index, waist circumference, body fat percentage, and estimated aerobic capacity. Uncertainty around the ICERs was captured by a probabilistic analysis using a non-parametric bootstrap method. The analysis was based on 60 patients enrolled between 2011 and 2013. Average intervention costs per participant were €412 in the exercise arm (n = 41) and €117 (n = 19) in the control arm. Total mean costs were €17,344 (standard deviation 9,928) and €20,615 (standard deviation 14,904), respectively, did not differ significantly (p = 0.51). The 6-month exercise program was deemed to be cost-effective compared with usual care for the estimated aerobic capacity. Multicenter randomized studies with long-term costs and outcomes should be done to provide additional evidence. Clinical trial: The PASAPAS study is registered under ClinicalTrials.gov. Trial registration ID: NCT01331772.

Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial.

PURPOSE: Lack of physical activity (PA), weight gain, and overweight have been associated with increased risk of recurrence and mortality after breast cancer diagnosis. We evaluated the feasibility of implementing an individualized exercise program and nutritional counseling during adjuvant treatment of localized invasive breast cancer. METHODS: Sixty-one patients eligible for adjuvant chemotherapy were randomized 2:1 to receive a 6-month program of weekly aerobic exercises associated with nutritional counseling (n = 41) or usual care with nutritional counseling (n = 20, one withdrawal). The primary endpoints were the proportion of patients compliant with two weekly supervised sessions and their overall adherence (i.e., proportion of supervised and unsupervised sessions completed versus planned sessions). RESULTS: Ten percent of patients in the intervention group were compliant with the two weekly supervised sessions for 6 months, but the overall median adherence rate was 85% of supervised and non-supervised sessions completed. Non-adherence was mainly due to intrinsic reasons (medical, organizational, psychological barriers). Adherence was positively associated with education and baseline PA level and inversely associated with baseline weight and tumor grade. No statistically significant benefits were observed in the intervention group, even if overall PA level and body composition improved and anthropometrics were maintained over time (p < 0.05). CONCLUSIONS: Overall, there was good adherence with the 6-month exercise program during adjuvant treatment for breast cancer, despite poor compliance to twice-weekly supervised sessions. This study highlights the need for flexible exercise modalities and innovative experimental design to reach patients who would most adhere and benefit from intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01331772. Registered 8 April 2011, https://clinicaltrials.gov/ct2/show/NCT01331772?term=pasapas&rank=1.

Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort.

Nutrition is often used by cancer survivors as a lever to take charge of their own health. However, some dietary behaviors are not currently recommended for patients without medical supervision. Our study aimed at evaluating weight-loss restrictive diets and fasting practices among cancer survivors of the NutriNet-Santé cohort, as well as related socio-demographic and lifestyle factors. In October 2016, 2,741 cancer survivors had completed a specific questionnaire about their practices. Fasting and non-fasting patients (respectively dieting and non-dieting) were compared using logistic regression models. Analyses were weighted according to the age, gender, and cancer location distribution of French cancer cases. 13.8% had already practiced weight-loss restrictive diet as their diagnosis. They were more likely to be women, professionally active, overweight/obese, to use dietary supplements and to have breast cancer (all p < 0.05). 6.0% had already fasted, 3.5% as their diagnosis. They were more likely to be younger, with higher educational level, higher incomes, professionally active, to have a healthy weight, and to use dietary supplements (all p < 0.05). Fasting was associated with the opinion that such practice could improve cancer prognosis (p < 0.0001). Patients who received nutritional information from health care professionals were less likely to practice fasting or weight-loss restrictive diet (0.42[0.27-0.66], p < 0.0001 and 0.49[0.38-0.64], p < 0.0001 respectively). Our study provided original results suggesting that weight-loss restrictive diets are widely practiced by cancer survivors. Fasting was less common in our study though non negligible. Sources of nutritional information received as cancer diagnosis seemed to be a key determinant of these practices.

Sociodemographic and economic factors are associated with weight gain between before and after cancer diagnosis: results from the prospective population-based NutriNet-Santé cohort.

PURPOSE: While many cancer patients are affected by weight loss, others tend to gain weight, which may impact prognosis and risk of recurrence and of second cancer. The aim of this prospective study was to investigate weight variation between before and after cancer diagnosis and socio-demographic, economic, lifestyle and clinical factors associated with moderate-to-severe weight gain. METHODS: 1051 incident cases of first primary cancer were diagnosed in the NutriNet-Santé cohort between 2009 and 2015. Weight was prospectively collected every 6 months since subjects' inclusion (i.e. an average of 2y before diagnosis). Mean weights before and after cancer diagnosis were compared with paired Student's t-test. Factors associated with moderate-to-severe weight gain (≥5% of initial weight) were investigated by age and sex-adjusted logistic regression. RESULTS: Weight loss was observed in men (-3.54±4.39kg in those who lost weight, p=0.0002) and in colorectal cancer patients (-3.94±4.40kg, p=0.001). Weight gain was observed in breast and skin cancers (2.83±3.21kg, p=0.04, and 2.96±2.75kg, p=0.04 respectively). Women (OR=1.75[1.06-2.87],p=0.03), younger patients (2.44[1.51-3.70],p<0.0001), those with lower income (OR=1.30[1.01-1.72],p-trend=0.007), lower education (OR=1.32[1.03-2.70],p-trend=0.03), excess weight before diagnosis (OR=1.64[1.12-2.42],p=0.01), lower physical activity (OR=1.28[1.01-1.64],p=0.04) and those who stopped smoking (OR=4.31[1.99-9.35],p=0.005]) were more likely to gain weight. In breast cancer patients, induced menopause was associated with weight gain (OR=4.12[1.76-9.67]), but no association was detected for tumor characteristics or treatments. CONCLUSION: This large prospective cohort provided original results on weight variation between before and after cancer diagnosis, highlighting different weight trajectories. Socio-demographic and economic factors appeared to influence the risk of weight gain, illustrating social inequalities in health.

Modifications in dietary and alcohol intakes between before and after cancer diagnosis: Results from the prospective population-based NutriNet-Santé cohort.

Postdiagnosis diet and alcohol consumption may be associated with cancer prognosis, recurrence and mortality. Our aim was to investigate food, nutrient and alcohol intake variations between before and after cancer diagnosis and their determinants in a prospective cohort. Subjects (n = 696) were incident cancer cases diagnosed in the NutriNet-Santé cohort between 2009 and 2016. Food, nutrient and alcohol intakes were prospectively collected using repeated nonconsecutive 24-hr dietary records since subjects' inclusion (i.e. an average of 2 y before diagnosis). Mean number of dietary records per subject was 5.9 before and 8.1 after diagnosis. All dietary data before and after diagnosis were compared by mixed models. Factors associated with the main dietary changes observed were also investigated using multivariable logistic regressions. We observed a decrease in intakes of vegetables (mean decrease in intake in patients who decreased their intake=-102.4 ± 79.8 g/d), dairy products (-93.9 ± 82.8 g/d), meat/offal (-35.5 ± 27.8/d), soy products (-85.8 ± 104.1 g/d), sweetened soft drinks (-77.9 ± 95.4 g/d), and alcoholic drinks (-92.9 ± 119.9 g/d), and an increase in broths (42.1 ± 34.9 g/d) and fats/sauces (18.0 ± 13.4 g/d). We observed a decrease in energy intake (-377.2 ± 243.5 kcal/d) and in intakes of alcohol (-7.6 ± 9.4 g/d) proteins (-17.4 ± 12.5 g/d), and several vitamins (p < 0.05) and micronutrients (p < 0.05). Conversely, lipid (19.4 ± 14.6 g/d), SFA (9.3 ± 7.0 g/d), MUFA (8.3 ± 6.3 g/d) and vitamin E (3.9 ± 3.3 mg/d) intakes increased after diagnosis. This large prospective study suggests that cancer diagnosis is a key period for nutritional changes. It highlights some healthy behaviors such as a decrease in alcohol and sweetened drink consumption, but also less favorable trends, such as a decrease in vegetable consumption and in many vitamin and mineral intakes. These results provide insights to identify and target recommendations to put forward for better nutritional care of cancer survivors.

ESPEN guidelines on nutrition in cancer patients.

Cancers are among the leading causes of morbidity and mortality worldwide, and the number of new cases is expected to rise significantly over the next decades. At the same time, all types of cancer treatment, such as surgery, radiation therapy, and pharmacological therapies are improving in sophistication, precision and in the power to target specific characteristics of individual cancers. Thus, while many cancers may still not be cured they may be converted to chronic diseases. All of these treatments, however, are impeded or precluded by the frequent development of malnutrition and metabolic derangements in cancer patients, induced by the tumor or by its treatment. These evidence-based guidelines were developed to translate current best evidence and expert opinion into recommendations for multi-disciplinary teams responsible for identification, prevention, and treatment of reversible elements of malnutrition in adult cancer patients. The guidelines were commissioned and financially supported by ESPEN and by the European Partnership for Action Against Cancer (EPAAC), an EU level initiative. Members of the guideline group were selected by ESPEN to include a range of professions and fields of expertise. We searched for meta-analyses, systematic reviews and comparative studies based on clinical questions according to the PICO format. The evidence was evaluated and merged to develop clinical recommendations using the GRADE method. Due to the deficits in the available evidence, relevant still open questions were listed and should be addressed by future studies. Malnutrition and a loss of muscle mass are frequent in cancer patients and have a negative effect on clinical outcome. They may be driven by inadequate food intake, decreased physical activity and catabolic metabolic derangements. To screen for, prevent, assess in detail, monitor and treat malnutrition standard operating procedures, responsibilities and a quality control process should be established at each institution involved in treating cancer patients. All cancer patients should be screened regularly for the risk or the presence of malnutrition. In all patients - with the exception of end of life care - energy and substrate requirements should be met by offering in a step-wise manner nutritional interventions from counseling to parenteral nutrition. However, benefits and risks of nutritional interventions have to be balanced with special consideration in patients with advanced disease. Nutritional care should always be accompanied by exercise training. To counter malnutrition in patients with advanced cancer there are few pharmacological agents and pharmaconutrients with only limited effects. Cancer survivors should engage in regular physical activity and adopt a prudent diet.

Variations of physical activity and sedentary behavior between before and after cancer diagnosis: Results from the prospective population-based NutriNet-Santé cohort.

Physical activity (PA) but also reduced sedentary behavior may be associated with better prognosis and lower risk of recurrence in cancer patients. Our aim was to quantify the variations in PA and time spent sedentary between before and after diagnosis, relying on prospective data in French adults. We also investigated sociodemographic and lifestyle factors associated with these variations.Subjects (n = 942) were incident cancer cases diagnosed in the NutriNet-Santé cohort between 2009 and 2015. PA and sedentary behavior were prospectively collected with the 7-day short version of the IPAQ questionnaire every year since subjects' inclusion (i.e., an average of 2 year before diagnosis). All PA and sitting time points before and after diagnosis was compared by mixed model. Factors associated with decrease in PA and increase in sitting time were investigated using logistic regressions.Overall and vigorous PA decreased after diagnosis (P = 0.006, -32.8 ±â€Š36.8 MET-hour/week on average, in those who decreased their overall PA and P = 0.005, -21.1 ±â€Š36.8 MET-hour/week for vigorous PA, respectively), especially in prostate (-39.5 ±â€Š36.3 MET-hour/week) and skin (-35.9 ±â€Š38 MET-hour/week) cancers, in men (-40.8 ±â€Š46.3MET-hour/week), and in those professionally inactive (-34.2 ±â€Š37.1 MET-hour/week) (all P < 0.05). Patients with higher PA level before diagnosis were more likely to decrease their PA (odds ratio [OR]: 4.67 [3.21-6.81], P < 0.0001). Overweight patients more likely to decrease moderate PA (OR: 1.45 [1.11-1.89], P = 0.006) and walking (OR: 1.30 [1.10-1.70], P = 0.04). Sitting time increased (P = 0.02, +2.44 ±â€Š2.43 hour/day on average, in those who increased their sitting time), especially in women (+2.48 ±â€Š2.48 hour/day), older patients (+2.48 ±â€Š2.57 hour/day), and those professionally inactive (2.41 ±â€Š2.40 hour/day) (all P < 0.05). Patients less sedentary before diagnosis were more likely to increase their sitting time (OR: 3.29 [2.45-4.42], P < 0.0001).This large prospective study suggests that cancer diagnosis is a key period for change in PA and sedentary behavior. It provides insights to target the subgroups of patients who are at higher risk of decreasing PA and increasing sedentary behavior after cancer diagnosis.

A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm.

BACKGROUND: Patients with gastrointestinal (GI) cancer are exposed to cachexia, which is highly correlated with chemotherapy-induced side effects. Research suggests that specific immunonutrients could prevent such toxicities. AIMS: The primary objective of this phase III study was to evaluate the efficacy of glutamine and transforming growth factor-ß2 (TGF-ß2) in the prevention of grade 3-4 non-hematological toxicities induced by chemotherapy in patients with GI cancer. PATIENTS AND METHODS: We designed a double-blind, randomized, controlled and multicenter trial stratified according to center, type of chemotherapy, presence of cachexia, and age. Patients were randomized to receive either Clinutren Protect(®) (CP) or a control isocaloric diet (without TGF-ß2 or glutamine). RESULTS: Between November 2007 and October 2011, 210 patients were enrolled in the study, of which 201 were included in the intention-to-treat analysis. Grade 3-4 non-hematological toxicities were not significantly different between the CP and control groups when evaluated by univariate and multivariate analyses. Likewise, no difference was observed regarding grade 3-4 hematological toxicities or reasons for treatment interruption. CONCLUSION: This randomized study does not support the hypothesis that oral glutamine and TGF-ß2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.

Dietary supplement use among cancer survivors of the NutriNet-Santé cohort study.

Dietary supplements (DS) may influence cancer prognosis. Their use in cancer patients has been described in the United States, but data are largely lacking in Europe and notably in France. The present study's objectives were (1) to assess DS use and its sociodemographic, lifestyle, and dietary correlates in a large sample of French cancer survivors; (2) to evaluate the involvement of physicians in such DS use; and (3) to assess the extent of potentially harmful practices. Data were collected by self-administered web-based questionnaires among participants of the NutriNet-Santé cohort. Data on DS use was available for 1081 cancer survivors. DS users were compared to non-users with unconditional logistic regressions. DS use was reported by 62% of women and 29% of men. Vitamins D, B6, C and Mg were the most frequently consumed nutrients. 14% of cancer survivors initiated DS use after diagnosis. For 35% of the DS consumed, subjects did not inform their attending physician. DS use was associated with a healthier lifestyle (normal weight, never smoking and better diet) and substantially contributed to nutrient intake. 18% of DS users had potentially harmful DS use practices, such as the simultaneous use of vitamin E and anticoagulant/antiplatelet agents, the use of ß-carotene and smoking or the use of phyto-oestrogens in hormone-dependent cancer patients. The present study suggests that DS use is widespread among cancer survivors, a large amount of that use is performed without any medical supervision and a substantial proportion of that use involves potentially harmful practices. Physicians should be encouraged to more routinely discuss DS use with their cancer patients.

Deterioration of Physical Activity Level and Metabolic Risk Factors After Early-Stage Breast Cancer Diagnosis.

BACKGROUND: In breast cancer patients, a lack of physical activity (PA) is 1 causative factor of weight gain during adjuvant treatment. It may increase the risk of treatment adverse effects, comorbidities, and deleterious long-term outcomes. OBJECTIVE: We aimed to describe the evolution of PA level and sedentary behavior in breast cancer patients between diagnosis and adjuvant chemotherapy onset following surgery and identify predictive factors associated with these changes early after breast cancer diagnosis. METHODS: Baseline data of 60 patients enrolled in a pilot randomized controlled trial of PA are presented. PA levels were estimated at adjuvant chemotherapy onset after surgery and retrospectively for the period at diagnosis. Height, weight, waist circumference, and bioelectrical impedance were measured at chemotherapy onset. Linear regression analysis evaluated factors associated with relative changes of PA level and sedentary behavior. RESULTS: Moderate PA decreased and sedentary behavior increased between diagnosis and chemotherapy onset. A grade III breast cancer was associated with a greater decrease in PA level. Conversely, keeping a professional occupation and adherence to nutritional guidelines were associated with maintained PA level. The majority (88%) of patients had excessive adiposity at chemotherapy onset. CONCLUSIONS: There was a significant deterioration of PA level between diagnosis and chemotherapy onset, and deleterious adiposity was present in most patients. IMPLICATIONS FOR PRACTICE: This study further emphasizes the need to motivate breast cancer patients toward engaging in a healthy lifestyle early after diagnosis and adhering to PA programs, which should be included in their clinical management.

[Physical activity and cancer survival]. / Activité physique et survie après cancer.

Physical activity has been shown in large cohort studies to positively impact survival in cancer survivors. Existing randomized controlled trials showed a beneficial effect of physical activity on physical fitness, quality of life, anxiety and self-esteem; however, the small sample size, the short follow-up and the lack of standardization of physical activity intervention across studies impaired definite conclusion in terms of survival. Physical activity reduces adiposity and circulating estrogen levels and increases insulin sensitivity among other effects. A workshop was conducted at the International Agency for Research on Cancer in April 2011 to discuss the role of physical activity on cancer survival and the methodology to develop multicentre randomized intervention trials, including the type of physical activity to implement and its association with nutritional recommendations. The authors discuss the beneficial effect of physical activity on cancer survival with a main focus on breast cancer and report the conclusions from this workshop.

Evaluation of the Bonfils intubating fibrescope for predicted difficult intubation in awake patients with ear, nose and throat cancer.

BACKGROUND AND OBJECTIVE: Anaesthesiologists are regularly faced with difficult tracheal intubation. The objective of the study was to evaluate the feasibility and tolerability of tracheal intubation with the Bonfils intubating fibrescope in awake adult patients with predicted difficult intubation undergoing cancer surgery in an ear, nose and throat unit. METHODS: Intubation was performed under local anaesthesia and remifentanil sedation with spontaneous ventilation. The primary endpoint was the proportion of intubations which met the following quality requirements: successful intubation (≤ 2 attempts and duration <180 s) and good tolerability (Fahey scale <2). Secondary endpoints included the operational problems encountered and patients' perception of the procedure immediately and 7 days after the intervention. Using a one-stage Fleming design, 32 patients were required to complete the study. Forty-one eligible adult patients were enrolled. RESULTS: Between February 2008 and March 2009, the primary endpoint could be evaluated in 33 patients. Quality requirements were met in 26 patients (78.8%) and not met in seven patients (five were intubated with the Bonfils fibrescope and two using another technique). Difficulties were reported in 13 patients (39.4%). Eighty-four percent of the patients had a good or very good perception of the intubation shortly after the procedure, and 91% after 7 days. CONCLUSION: Tracheal intubation using the Bonfils intubating fibrescope was successful in almost all patients (93.9%). The 78.8% incidence of interventions which met the quality requirements is high in the context of ear, nose and throat cancer and acceptable in current clinical practice. In ear, nose and throat cancer patients who do not require nasopharyngeal intubation and in whom orotracheal intubation is predicted to be difficult, the use of the Bonfils intubating fibrescope is safe, effective and well tolerated. CLINICAL TRIAL REGISTRATION NUMBER: NCT01070537, URL: http://clinicaltrials.gov/ct2/show/NCT01070537?term=bonfils&rank=2.

A telephone-linked computer system for home enteral nutrition.

We studied the effect of telephone-linked computer (TLC) communication in patients being treated with home enteral nutrition. A total of 290 patients were enrolled in the study which compared two groups of patients who were recruited at different times (control: 193, TLC: 97). At baseline there were no significant differences in characteristics or clinical practice between the two groups. Over a three-month period, 823 automatic telephone calls were dialled out to the TLC patients and in 787 of the calls (96%) there were complete responses to all questions. A total of 205 alert messages were generated for the 823 calls. Less than 10% were false alerts. All health outcome measures, the EQ-5D and three components of the SF-36 improved slightly with time in both groups, but there was no significant difference between the groups. The patients' body mass index increased slightly in both groups, but the change was not significant. Home enteral nutrition prevented weight loss and improved some components of the QOL scores. The TLC system detected a high number of abnormal nutritional symptoms.

Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study.

BACKGROUND & AIMS: Adjuvant chemotherapy has frequently been associated with weight gain after breast cancer diagnosis. We aimed to prospectively evaluate body weight variations in French patients with early breast cancer. METHODS: This prospective observational study included 272 breast cancer patients who were candidates for adjuvant chemotherapy. Weight and body mass index were measured at baseline visit, then at 9 and 15 months from baseline (6 and 12-month post-chemotherapy). At baseline visit, information on the benefits of weight gain prevention and healthy diet was given by a dietician. Univariate logistic regression was performed to test the association between weight gain and potential predictive factors. RESULTS: Thirty percent of patients gained weight during the year before diagnosis, 26% were overweight and 15% were obese. At one year, the mean weight change was +1.5kg (SD=4.1) and +2.3% (SD=6.0); 60% of the cohort had gained weight, with a median increase of 3.9kg (SD=3.0) and 5.9% (SD=4.4). Reported weight gain during the year before diagnosis appears to be the only factor associated with the absence of post-chemotherapy weight gain (OR=0.54, 95% CI [0.31-0.95], p=0.034). CONCLUSION: Body weight increased in the post-chemotherapy period in French breast cancer survivors, even when given dietary recommendations. Appropriate weight management interventions with nutritional follow-up and physical activity programs are needed.

Nutritional risk factors in planned oncologic surgery: what clinical and biological parameters should be routinely used?

BACKGROUND: Screening for malnutrition is recommended in hospitalized and planned surgical patients. The aim of this study was to analyze the feasibility and routine prognostic value of using the principal recommended nutritional screening and evaluation tools for cancer patients undergoing major surgery. METHODS: This study is a prospective, 3-month, multicenter observational trial recording weight loss, body mass index, albumin, transthyretin, and PG-SGA. The morbidity rate was assessed on the basis of major complications (MC), whether of an infectious (MIC) or noninfectious (MNIC) nature. RESULTS: Two hundred seventy-five patients were recruited at nine centers. The following percentages were recorded with respect to morbidity: 28.4% MC, 12.7% MIC, and 22.2% MNIC. Univariate analysis revealed a statistical association only between weight loss greater than 10% and MIC and hospital stay. A weight loss of 15% is required to demonstrate an association with either MC, MIC, or MNIC. Body mass index (BMI) was associated only with MNIC, PG-SGA with MC, and albumin <30 g/l was strongly associated with all types of morbidity (MC, MIC, MNIC). Multivariate analysis indicated that only albumin <30 g/l and an operating time of more than 4 h are significantly associated with morbidity. CONCLUSIONS: In this study, the best nutritional factor for detecting the risk of MC is albumin levels below 30 g/l. A weight loss greater than 15% is required to obtain a statistically significant correlation with the existence of MC.