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Perioperative chemotherapy is BPH Chirurgie postoperative Phase gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based BPH Chirurgie postoperative Phase 3 components: 1 physical management, 2 nutritional care and 3 psychological care.
Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment. The PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with BPH Chirurgie postoperative Phase chemotherapy.
This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, BPH Chirurgie postoperative Phase survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy defined by the VO 2peakventilatory threshold and BPH Chirurgie postoperative Phase walk testpreoperative and postoperative nutritional status, preoperative anxiety, quality of life, day and day mortality and cumulative dose of cytotoxic treatment received.
The results will be disseminated in a peer-reviewed journal. Perioperative chemotherapy is the gold standard treatment of the resectable and advanced gastro-oesophageal adenocarcinoma. The efficacy of this strategy has been demonstrated in two randomised studies. Disease-free survival DFS and overall survival OS rates were significantly improved with perioperative chemotherapy compared to surgery alone.
This sequence is defined by the administration of two to four cycles before and two to four cycles after the surgery, according to the protocol. The major cause of absence or impossibility of realisation of postoperative chemotherapy was the presence of postoperative complication, postoperative serious asthenia and impaired nutritional and physical status.
To the best of our knowledge, no study has ever focused on gastro-oesophageal cancer. The aim of this study was to compare the percentage of patients reaching the complete oncological treatment previously decided in a multidisciplinary tumour board in the group with prehabilitation to the group with BPH Chirurgie postoperative Phase care, in patients with gastro-oesophageal adenocarcinoma. The present study is a prospective, randomised, controlled, open and multicentric phase III trial that compares prehabilitation Prehab group versus conventional care control group in patients presenting with gastric and low oesophageal adenocarcinoma, treated by perioperative chemotherapy.
Inclusions will be performed in four French tertiary centres figure 1. In the experimental group Prehab groupthe main objective was to demonstrate an improvement in the percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board. To be included in the study, the participant is scheduled for surgical BPH Chirurgie postoperative Phase of gastric or oesophageal adenocarcinoma and received perioperative chemotherapy, insured under the French social security system and have signed documents to mark their free, prior and informed consent.
Finally, patients already included in another clinical trial, or estimated by the investigator to not be able to be compliant with the criteria of the study, or with legal incapacity person deprived of liberty or subject under guardianship will not be enrolled in this study.
Guidelines regarding stopping participation are: withdrawal of patient consent, non-compliance of the patient, adverse event and by decision of the investigator. In case of withdrawal from the study, the patient will be followed up and managed normally in the digestive surgery department.
After the first visit to his surgeon, the patient will be presented to the multidisciplinary tumour board to validate the inclusion criteria and to schedule the number of cycles of preoperative and postoperative chemotherapy. After this step, a second consultation with the surgeon will take place to verify all inclusion and exclusion criteria and perform the randomisation. For the two groups, an initial before chemotherapy and final 1-week before the surgery evaluation will be performed.
The participant will exercise in the presence of the physical therapist who will provide corrective feedback, if necessary. Nutrition intervention: Initially, a nutritionist will perform BPH Chirurgie postoperative Phase medical examination running appropriate biological tests to evaluate the nutritional status and to provide individualised care to each patient.
Individual protein requirements will be calculated as 1. After the preoperative chemotherapy, a second evaluation by a nutritionist will be performed.
Each patient will practise these exercises with the psychologist initially and at each cycle of chemotherapy and at home two to three times per week. Once performed, the exercises at home will be marked on diaries. BPH Chirurgie postoperative Phase psychologist also provides suggestions on how to enhance and reinforce patients' motivation to comply with the exercise and nutritional aspects of the intervention. The control group will be treated according to conventional care and will not receive any specific intervention before surgery except nutritional support BPH Chirurgie postoperative Phase physiotherapy at the surgeon's discretion.
The primary outcome is, in patients presenting with gastric or oesophageal adenocarcinoma, the percentage of patients in each group receiving the full perioperative oncological treatment, previously defined by a multidisciplinary tumour board. However, a decrease in the dose of chemotherapy or a stop of a component of chemotherapy will not be considered as an event.
The trial will be performed in four centres. Then, the multidisciplinary tumour board will check all the inclusion and exclusion criteria, the PREHAB trial will be proposed by surgeons to patients with gastric or oesophageal adenocarcinoma and with concomitant perioperative chemotherapy.
Randomisation will be carried out using a dedicated centralised telephone system and accessible round the clock. The trial will be open blinded because of the procedures employed and with an objective primary end point. The patient will be informed of the randomisation arm throughout the trial. The only criteria, which will be recorded, to discontinue or, or modifying allocated interventions for a given trial participant is the participant request.
Finally, BPH Chirurgie postoperative Phase total of 60 patients by group will be considered. The type I error is fixed at 0. Normality will be studied by the Shapiro-Wilk test and homoscedasticity using the Fisher-Snedecor test. The analysis of the primary outcome will be complemented by multivariate analysis using the generalised linear mixed model logistic for a dichotomous dependent variable to take into account 1 fixed effects covariates retained according to univariate analysis results and clinical relevance and 2 random effects between and within centre and surgeon variabilities.
Censored data such as OS or event-free survival will be estimated using the Kaplan-Meier method and compared 1 by log-rank test in univariate situation and 2 using the Cox proportional hazard model in the multivariate context.
In the prehab group, a dose—response study will be proposed to assess 1 the impact of the number of prehabilitation sessions really realised and 2 the compliance prehabilitation care dietary and nutritional management. Particular focus will be placed on loss to follow-up.
A study with the abandonment considered as censored data will be proposed using the Kaplan-Meier estimation. The approval of the committee was obtained on 7 March Authorisation was obtained on 21 December Any substantial change in the protocol or in the informed consent form will be presented to both authorities as well as first inclusion, interim analyses and end BPH Chirurgie postoperative Phase study.
Data monitoring will be performed as per French regulations requirements. Data will be collected at each trial visit every 2 months and at the interim analyses, regarding any adverse events AE and serious AE. All serious AE causally related to treatment procedures will be reported to the relevant ethics committees, the lead site and the independent data and DSMC for their review and recommendations. The DSMC comprises independent clinicians with an interest in prehabilitation and a statistician.
Overview is carried out through the review of AE and serious AE, all of which are reported at the regular committee meetings. The current protocol version is the first since 20 April BPH Chirurgie postoperative Phase According to international regulations on clinical trials, written informed consent will be obtained BPH Chirurgie postoperative Phase patients prior to their participation in the study see online supplementary appendices 1 and 2.
Patients will voluntarily confirm their understanding and willingness to participate in the study after having been informed in writing and verbally by oncologists on all aspects of the study. They will also be informed about requirements regarding data protection and direct access to their individual data. BPH Chirurgie postoperative Phase patients will be informed that they are free to withdraw from the study at any time at their own discretion, without necessarily giving reasons.
Experienced and trained study coordinators will be dedicated to data acquisition, coding, security and storage, under the responsibility of investigators.
Each study data will be anonymised. Data will be recorded in paper case report forms at the time of each patient contact. These BPH Chirurgie postoperative Phase be faxed to the study lead site for checking followed by entry into the secure study database. A clinical research assistant will be commissioned by the sponsor University Hospital of Clermont-Ferrand in order to monitor the progress of the study in accordance with the Standard Operating Procedures implemented at the University Hospital of Clermont-Ferrand, in accordance with the Good Clinical Practice and current French laws.
However, the principal investigator BPH Chirurgie postoperative Phase the project manager will have full access to the final data set. The results will be communicated in a peer-reviewed journal, presented at international congresses and summarised on ClinicalTrials. Perioperative chemotherapy became the gold standard treatment in advanced gastric and low oesophageal adenocarcinoma, with an improvement of DFS and OS.
In these studies, only patients in good nutritional and physical status without postoperative complications can receive postoperative treatment. BP led the development of the statistical analysis plan. BL participated in the design of the protocol for interventions and assessments.
All authors have read and approved the final manuscript. The study sponsor and funders had no role and will BPH Chirurgie postoperative Phase have any authority over: study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.
Competing interests: None declared. Patient consent: Obtained. Provenance and peer review: Not commissioned; externally peer reviewed. Data sharing statement: The additional unpublished data can be available by the mail of the corresponding author.
National Center for Biotechnology InformationU. BMJ Open. Published online Dec 7. Author information Article notes Copyright and License information Disclaimer. Correspondence to Dr Bertrand Le Roy; moc. This article has been cited by other articles in PMC.
Associated Data Supplementary Materials supplementary data. Abstract Introduction Perioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. Methods and analysis The PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy.
Keywords: Prehabilitation, Gastric cancer, Fitness. Strengths and limitations of this study. Introduction Perioperative chemotherapy is the gold standard treatment of the resectable and advanced gastro-oesophageal adenocarcinoma.
Methods and analysis Study setting The present study is a prospective, randomised, controlled, open and multicentric phase III trial that compares prehabilitation Prehab group versus conventional care control group in patients presenting with gastric and low oesophageal adenocarcinoma, treated by perioperative chemotherapy. Open in a separate BPH Chirurgie postoperative Phase.
Study objectives In the experimental group Prehab groupthe main objective was to demonstrate an improvement in the percentage of patients reaching the complete oncological treatment fixed in BPH Chirurgie postoperative Phase multidisciplinary tumour board. Inclusion and exclusion criteria To be included BPH Chirurgie postoperative Phase the study, the participant is scheduled for surgical intervention of gastric or oesophageal adenocarcinoma and received perioperative chemotherapy, insured under the French BPH Chirurgie postoperative Phase security system and have signed documents BPH Chirurgie postoperative Phase mark their free, prior and informed consent.
Interventions After the first visit to his surgeon, the patient will be presented to the multidisciplinary tumour board to validate the inclusion criteria and to schedule the number of cycles of preoperative and postoperative chemotherapy.
Control group The control group will be treated according to conventional care and will not receive any specific BPH Chirurgie postoperative Phase before surgery except nutritional support and physiotherapy at the surgeon's discretion.