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QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.

ABSTRACT: BACKGROUND:Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life. METHODS:At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores. RESULTS:Patients receiving nutritional counseling reported less appetite loss (MD -?17.7, 95% CI -?32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD -?3.1, 95% CI -?10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI -?5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI -?5.9 to 7.2). CONCLUSIONS:Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.

SUBMITTER: Pinto E

PROVIDER: S-EPMC7307937 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.

Pinto Eleonora E Nardi Maria Teresa MT Marchi Rita R Cavallin Francesco F Alfieri Rita R Saadeh Luca L Cagol Matteo M Baldan Ilaria I Saraceni Elisabetta E Parotto Matteo M Baratto Fabio F Caberlotto Cristina C Vianello Andrea A Castoro Carlo C Scarpa Marco M

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20200622 2

<h4>Background</h4>Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life.<h4>Methods</h4>At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first mo ...[more]

PMID: 32572611

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Project description:For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer.This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ? 18 and ? 80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (n = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (n = 56) or open three-stage transthoracic esophageal resection (n = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications.This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient.Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790.

Project description:Background: Locally advanced head and neck cancer is managed either by combined surgery and (chemo) radiotherapy or definitive (chemo) radiotherapy, which may deteriorate nutritional status. Previous data have shown that intensive nutritional intervention by a dietician reduces radiation-induced adverse events including weight loss. Objective: To determine if on-demand nutritional counseling (ODC, control group) would be as efficacious as intensive nutritional counseling (INC, experimental group) in patients undergoing (chemo) radiotherapy. Methods: Fifty-eight patients were randomly assigned to receive INC (n = 26) or ODC (n = 32). Outcome measures were nutritional status (PG-SGA), weight loss, handgrip strength (HGS), body composition, and survival. Results: Weight loss and impaired nutritional parameters during oncological treatment were seen equally in both groups (NS). Leaner patients at baseline maintained their weight, while overweight patients lost both weight and handgrip strength during treatment. Disease-free survival (DFS) (median = 43 months) was not affected by weight loss during treatment. Lower baseline HGS and malnutrition were associated with worse DFS (low vs. normal HGS: 15 vs. 42 months; p = 0.05 and malnutrition vs. good nutrition status: 17 vs. 42 months; p = 0.014, respectively). Survival according to low vs. normal HGS in the INC group was 4 vs. 44 months (p = 0.007) and in the ODC group 28 vs. 40 months (p = 0.944). According to malnutrition vs. good nutritional status in the INC group, DFS was 21 vs. 43 months (p = 0.025) and in the ODC group 15 vs. 41 months (p = 0.03). Conclusions: As for our primary endpoint, individualized on-demand nutritional counseling was as efficacious as intensive counseling in preventing deterioration of nutritional status and incidence of malnutrition during (chemo) radiotherapy. This should be verified with larger number of patients. Additional findings were that overweight patients had more severe weight loss, but not poorer survival. Low HGS and malnutrition at baseline were associated with poor survival. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02159508.

Project description:BackgroundMalnutrition and metabolic alterations of cancer cachexia are often associated with negative weight loss and muscle mass wasting. In this sense, protein supplementation can be a strategy to help counteract the loss and/or maintenance of mass in these patients. The aim of this study was to evaluate the effect of leucine supplementation on body composition in outpatients with gastrointestinal tract cancer.MethodsIt was a randomized, blinded, controlled, parallel trial, performed in male patients with a cancer diagnosis of the gastrointestinal tract and appendix organs undergoing chemotherapy. All the patients were allocated to one of the protocol groups: L-leucine supplement or the control group, during 8 weeks of intervention. We evaluated the body composition through bioelectrical impedance analysis, the cancer cachexia classification, and the diet intake before and after the intervention protocol. The intention-to-treat approach was performed to predict the missing values for all patients who provide any observation data.ResultsThe patients were an average age of 65.11 ± 7.50 years old. In the body composition analysis with patients who finished all the supplementation, we observed a significant gain in body weight (61.79.9 ± 9.02 versus 64.06 ± 9.45, p = 0.01), ASMM (7.64 ± 1.24 versus 7.81 ± 1.20, p = 0.02) in the Leucine group, whereas patients in the control did not present significant variation in these parameters. There was no significant intergroup difference. While in the analysis included the patients with intention-to-treat, we found a significant increase in body weight (p = 0.01), BMI (p = 0.01), FFM (p = 0.03), and ASMM (p = 0.01) in the Leucine group. No significant intergroup differences. These results also similar among cachectic patients.ConclusionA balanced diet enriched with free-Leucine supplementation was able to promotes gains in body weight and lean mass in older men diagnosticated with gastrointestinal and appendix organs of digestion cancer after 8 weeks. However, the fact that most men are non-cachectic or pre-cachectic is not clear if the increase in muscle mass was due to a high intake of leucine, since no difference between groups was detected. Moreover, we know that benefits on body composition are due to adequate calorie and macronutrients consumption and that balanced feeding according to nutrition Guidelines seems crucial and must be advised during the oncological treatment.

Project description:BackgroundNutritional status is an important prognostic factor in Amyotrophic Lateral Sclerosis (ALS). We wished to study the safety, tolerability and efficacy of nutritional counseling with or without an mHealth application to maintain or increase body weight in ALS, compared to standard care.MethodsIn this randomized open-label, standard-of-care-controlled, single-center clinical trial, we randomly assigned adults with ALS to one of three nutritional interventions: counseling by their physician or nurse ("standard care"), counseling by a registered dietitian (RD) ("in-person"), or counseling supported by a mHealth app ("mHealth"). Both intervention arms received tailored nutrition recommendations and recorded dietary intake and weight biweekly (mHealth) or monthly (in-person). The primary outcome of weight and secondary and tertiary outcomes of calorie intake, ALSFRS-R, and quality of life (QOL) were recorded at each clinic visit and analyzed in an ITT mixed model analysis.ResultsA total of 88 participants were enrolled of whom 78 were included in this analysis. The three arms were well-balanced except for excess males in the mHealth arm and greater weight lost at baseline in the in-person arm. Participants in the mHealth arm increased their calorie intake at month 3 to an average of 94% (95% CI: 85, 103) of recommended calories, compared to 81% (95% CI: 72, 91, p = 0.06 vs. mHealth) in the standard care arm. After 6 months, calorie intake was not different among the three arms. Overall weight was stable across all three groups. QOL scores in the mHealth arm were stable over 3 months (0.3 points, 95% CI: - 1.7, 2.2) compared to worsening in standard care (- 2.1 points, 95% CI: - 4.0, - 0.2, p = 0.09 vs. mHealth), but all scores declined by 6 months. ALSFRS-R total scores declined by an average of - 2.6 points (95% CI: - 5.1, - 0.1) over 6 months in the mHealth arm (p = 0.13 vs. standard care) compared to - 5.8 points (95% CI: - 8.2, - 3.4, p = 0.74 vs. standard care) in the in-person and - 5.2 points (95% CI: - 7.6, - 2.9) in the standard care arm.ConclusionsNutritional counseling by a registered dietitian (with or without support by an mHealth app) is safe but did not maintain weight significantly better than standard care in ALS patients.Trial registrationhttps://clinicaltrials.gov/ identifier NCT02418546. Registered April 16, 2015.

Project description:BACKGROUND:Undernutrition during pregnancy affects birth outcomes adversely. In Ethiopia, despite nutrition counseling on the maternal diet being given by the health workers during pregnancy, maternal undernutrition is still high in the country. Hence, this study aimed to assess the effect of guided counseling using the health belief model and the theory of planned behavior on the nutritional status of pregnant women. METHODS:A two-arm parallel cluster randomized controlled community trial was conducted in West Gojjam Zone, Ethiopia, from May 1, 2018, to April 30, 2019. The nutritional status of the women was assessed using mid-upper arm circumference. A total of 694 pregnant women were recruited from the intervention (n=346 ) and control (n=348) clusters. Of which endline data were collected from 313 and 332 pregnant women in the intervention and control clusters, respectively. The intervention was started before 16?weeks of gestation and pregnant women in the intervention group attended 4 counseling sessions. Counseling was given at the participants' homes using a counseling guide with the core contents of the intervention. Leaflets with appropriate pictures and the core messages were given for women in the intervention arm. Women in the control group got the routine nutrition education given by the health care system. Data were collected using interviewer administered structured questionnaires and mid-upper arm circumference was measured using an adult MUAC tape. Descriptive statistics and linear mixed-effects model were used to assess the intervention effect after adjusting for potential confounders. RESULTS:After the intervention, the prevalence of undernutrition was 16.7% lower in the intervention group compared with the control arm (30.6% Vs 47.3%, P?=?<?0.001). Women in the intervention group showed significant improvement in nutritional status at the end of the trial than the control group (??= 0.615, p?=?<?0.001). CONCLUSION:This study demonstrated that guided counseling using the health belief model and the theory of planned behavior was effective in improving the nutritional status of pregnant women. The results imply the need for the design of model and theory based nutrition counseling guidelines. The trial was registered in Clinical Trials.gov (NCT03627156).

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Project description:BackgroundAnatomically, the esophagus is located within the mediastinum, and thus it potentially a transcervical approach for esophagectomy, which avoids thoracic manipulation, could be an alternative to transthoracic esophagectomy for the surgical resection of esophageal cancer. A modified transcervical minimally invasive esophagectomy (MIE), laparo-gastroscopic esophagectomy (LGE), was recently introduced using an integrated gastroscope to mobilize the esophagus. As such, a randomized controlled trial (RCT) is necessary to validate its value compared to transthoracic MIE, which carries a high risk of morbidity due to thoracic manipulation.MethodsThis prospective study plans to enroll patients with resectable esophageal cancer with a pathological diagnosis of squamous cell carcinoma or adenocarcinoma patients over a 2-year period. Patients will be randomly assigned to one of 2 groups in a 1:1 ratio: patients in Group A will radical LGE and patients in Group B will receive radical laparo-thoracoscopic esophagectomy (LTE). Perioperative and long-term outcomes of all patients will be collected and analyzed. The primary end point will be perioperative morbidity, and the secondary end points will include 5-year overall survival (OS) and disease-free survival (DFS) and quality of life (QOL) score. Other data that will be collected and compared between the groups include the number of harvested lymph nodes, surgical Apgar score, and duration of operation.DiscussionTransthoracic MIE is the most widely accepted approach for treating esophageal cancer. In this RCT, transthoracic MIE and transcervical LGE will be compared with respect to oncological and surgical outcomes (oncological none-inferiority and surgical superiority).Trial registrationThis study is registered in Chinese Clinical Trial Registry (ChiCTR2200055312) with the name of 'Transcervical versus Transthoracic Minimally Invasive Esophagectomy: A Randomized and Controlled Trial' on January 6, 2022. Details can be found on http://www.chictr.org.cn/showproj.aspx?proj=133224.

Dataset Information

QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.

Publications

QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.

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