TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program

Lambaudie, Éric; Bannier, Cécile; Braticevic,; Villaron, Charlène; Goetgheluck,; Zemmour, Christophe; Boher, Jean‐Marie; Soussan, Patrick Ben; Pakradouni, Jihane; Brun, Clément; Almeida, Leonor Lopez; Marino, Patricia

doi:10.1136/ijgc-2020-002128

Cited by 14 publications

(16 citation statements)

References 15 publications

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“…Despite the lack of body composition changes in our subset of NACT patients, there is growing evidence that pre-habilitation protocols, as part of the enhanced recovery after surgery concept, may improve surgical outcomes, by bringing a fitter patient to surgery and decreasing treatment morbidity ( 53 ). Therefore, further studies, including lager cohorts selected in a prospective way ( 54 ), will provide deeper insights into the importance of changes in body composition before major surgery, also in the subset of NACT patients.…”

Section: Discussionmentioning

confidence: 99%

Computed Tomography–Based Body Composition in Patients With Ovarian Cancer: Association With Chemotoxicity and Prognosis

et al. 2021

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PurposeTo assess the association between computed tomography (CT)-derived quantitative measures of body composition profiling and chemotherapy-related complications, in terms of dose reduction, premature discontinuation of chemotherapy, and cycle delays in patients with ovarian cancer. Secondary purposes were to evaluate associations between sarcopenia and survival, and to evaluate differences in body composition profiling at baseline and after neoadjuvant chemotherapy.Materials and MethodsThe study population was retrospectively selected from a database of patients with newly diagnosed ovarian cancer (any stage) referred to our Institution between Feb 2011 and Mar 2020. Clinical data were recorded, and CT images at the level of the 3rd lumbar vertebra were stored. By using specific software, skeletal muscle area (SMA), subcutaneous adipose tissue (SAT), visceral adipose tissue (VAT), and skeletal muscle density (SMD) were extracted. Skeletal muscle index (SMI) was then calculated. Statistical analysis was performed by logistic regression models to identify body composition features predictive of dose reduction, premature end of chemotherapy, and cycle delays. Kaplan-Meier analyses were performed to assess overall survival (OS) and progression-free survival (PFS). The log-rank test was used to determine differences in OS and PFS between sarcopenic and non-sarcopenic patients. Wilcoxon test was performed to compare body composition features before and after neoadjuvant chemotherapy (NACT).ResultsSixty-nine patients were included. A significant association was found between VAT and cycle delays (OR = 1.01, z = 2.01, 95% CI: 1.00–1.02, p < 0.05), between SMA and early discontinuation of chemotherapy (OR = 1.03, z = 2.10, 95% CI: 1.00–1.05, p < 0.05), and between mean SMD and cycle delays (OR = 0.92, z = −2.70, 95%CI: 0.87–0.98, p < 0.01). No significant difference emerged for OS in sarcopenic and non-sarcopenic patients, nor in CT body composition features before and after NACT.ConclusionsIn ovarian cancer patients, CT-derived body composition profiling might predict the risk of chemotoxicity. In particular, VAT and SMD are associated with chemotherapy cycle delays, and SMA with early discontinuation of chemotherapy.

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Section: Discussionmentioning

confidence: 99%

Computed Tomography–Based Body Composition in Patients With Ovarian Cancer: Association With Chemotoxicity and Prognosis

et al. 2021

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“…In addition to having a human support system, participants taking part in remote prehabilitation interventions identi ed progress tracking in the form of pedometers and diaries as highly motivating (39,40,42). This supports the use of wearable devices in trial protocols (25,27,30) whereby patients will have real-time tness measures and outcomes that can be reported to healthcare professionals.…”

Section: The Motivation Of Patients To Engage In Prehabilitationmentioning

confidence: 71%

“…The 24 articles included nine registered protocols for randomised controlled trials of prehabilitation interventions (23)(24)(25)(26)(27)(28)(29)(30)(31), six observational studies (of which four were abstracts only) (32)(33)(34)(35)(36)(37), three mixed-methods studies (38)(39)(40), two qualitative studies (41,42), two cross-sectional surveys (43,44), one costeffectiveness analysis (45) and one review (46) (Table 2). 'Last chance to live normally'.…”

Section: Resultsmentioning

confidence: 99%

Considerations for multimodal prehabilitation in women with gynaecological cancers: A realist scoping review

Saggu

Barlow

Butler

et al. 2022

Preprint

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Background: There is increasing recognition that prehabilitation is important as a means of preparing patients physically and psychologically for cancer treatment, however, little is understood about the role of prehabilitation for gynaecological cancer patients. Review question: This scoping review was conducted to collate the research evidence on multimodal prehabilitation in gynaecological cancers and the related barriers and facilitators to delivery and engagement that should be considered when designing a prehabilitation model for this group of women. Methods: Seven medical databases and four grey literature repositories were searched from database inception to September 2021. All articles, except for opinion papers and social media posts, surrounding multimodal prehabilitation in gynaecological cancers were included in the final review. All qualitative papers including gynaecological cancer patients were included, irrespective of whether the intervention of interest was unimodal or multimodal. A realist framework of context, mechanism and outcome was used to assist interpretation of findings. Results: In total, 24 studies were included in the final review. The studies included the following tumour groups: ovarian only (n=12), endometrial only (n=1), mixed ovarian, endometrial, vulvar (n=5) and non-specific gynaecological tumours (n=6). There was considerable variation across studies in terms of screening, delivery of prehabilitation and measured outcomes. Key mechanisms and contexts underpinning engagement with prehabilitation can be summarised by 5 overarching themes: 1) The role of healthcare professionals and organisations 2) Acceptability of prehabilitation 3) Patient motivation 4) Prioritisation of prehabilitation 5) Accessibility of prehabilitation. Implications for practice: A standardised and well evidenced prehabilitation programme for women with gynaecological cancer does not yet exist. Healthcare organisations and researchers should take into account the enablers and barriers to effective engagement by healthcare professionals and by patients, when designing and evaluating prehabilitation for gynaecological cancer patients.

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“…In two studies on colorectal patients, a prehabilitation program markedly improved functional recovery after resection, thereby underscoring the program’s potentially large benefit for patients [ 36 , 37 ]. In the context of neoadjuvant treatment, a study is currently underway for evaluating the effect that a concomitant prehabilitation program (conducted during chemotherapy) has on treatment outcomes and morbidity in patients with ovary cancer [ 38 ]. Similarly, another group has evaluated the effect that a prehabilitation program has on functional outcomes, particularly swallowing and the quality of life among patients undergoing radiochemotherapy for head and neck cancer [ 39 ].…”

Section: Discussionmentioning

confidence: 99%

An Activity Tracker–Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials)

Hauth¹,

Gehler²,

Nieß³

et al. 2021

JMIR Res Protoc

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Background The positive impact that physical activity has on patients with cancer has been shown in several studies over recent years. However, supervised physical activity programs have several limitations, including costs and availability. Therefore, our study proposes a novel approach for the implementation of a patient-executed, activity tracker–guided exercise program to bridge this gap. Objective Our trial aims to investigate the impact that an activity tracker–guided, patient-executed exercise program for patients undergoing radiotherapy has on cancer-related fatigue, health-related quality of life, and preoperative health status. Methods Patients receiving postoperative radiotherapy for breast cancer (OnkoFit I trial) or neoadjuvant, definitive, or postoperative treatment for other types of solid tumors (OnkoFit II trial) will be randomized (1:1:1) into 3-arm studies. Target accrual is 201 patients in each trial (50 patients per year). After providing informed consent, patients will be randomized into a standard care arm (arm A) or 1 of 2 interventional arms (arms B and C). Patients in arms B and C will wear an activity tracker and record their daily step count in a diary. Patients in arm C will receive personalized weekly targets for their physical activity. No further instructions will be given to patients in arm B. The target daily step goals for patients in arm C will be adjusted weekly and will be increased by 10% of the average daily step count of the past week until they reach a maximum of 6000 steps per day. Patients in arm A will not be provided with an activity tracker. The primary end point of the OnkoFit I trial is cancer-related fatigue at 3 months after the completion of radiotherapy. This will be measured by the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. For the OnkoFit II trial, the primary end point is the overall quality of life, which will be assessed with the Functional Assessment of Cancer Therapy-General sum score at 6 months after treatment to allow for recovery after possible surgery. In parallel, blood samples from before, during, and after treatment will be collected in order to assess inflammatory markers. Results Recruitment for both trials started on August 1, 2020, and to date, 49 and 12 patients have been included in the OnkoFit I and OnkoFit II trials, respectively. Both trials were approved by the institutional review board prior to their initiation. Conclusions The OnkoFit trials test an innovative, personalized approach for the implementation of an activity tracker–guided training program for patients with cancer during radiotherapy. The program requires only a limited amount of resources. Trial Registration ClinicalTrials.gov NCT04506476; https://clinicaltrials.gov/ct2/show/NCT04506476. ClinicalTrials.gov NCT04517019; https://clinicaltrials.gov/ct2/show/NCT04517019. International Registered Report Identifier (IRRID) DERR1-10.2196/28524

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TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program

Cited by 14 publications

References 15 publications

Computed Tomography–Based Body Composition in Patients With Ovarian Cancer: Association With Chemotoxicity and Prognosis

Computed Tomography–Based Body Composition in Patients With Ovarian Cancer: Association With Chemotoxicity and Prognosis

Considerations for multimodal prehabilitation in women with gynaecological cancers: A realist scoping review

An Activity Tracker–Guided Physical Activity Program for Patients Undergoing Radiotherapy: Protocol for a Prospective Phase III Trial (OnkoFit I and II Trials)

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