Exercise Prehabilitation for Esophageal Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Disqualifiers: Unstable cardiac, Pulmonary, Recent fracture, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The purpose of the study is to examine the feasibility and acceptability of exercise "prehabilitation" for patients preparing for esophageal cancer resection (removal).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training for esophageal cancer?
Is exercise prehabilitation safe for esophageal cancer patients?
How does exercise prehabilitation differ from other treatments for esophageal cancer?
Exercise prehabilitation is unique because it focuses on improving a patient's physical fitness before surgery, which can help reduce muscle loss and improve recovery. Unlike traditional treatments that target the cancer directly, this approach aims to enhance the patient's overall health and ability to tolerate surgery and chemotherapy.1891011
Research Team
Nathan Parker, PhD, MPH
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
This trial is for individuals preparing for esophageal cancer surgery. It's designed to see if exercising before the operation, known as 'prehabilitation,' is doable and acceptable.Inclusion Criteria
My esophageal cancer is confirmed by biopsy and has not spread far.
My treatment plan includes chemotherapy, radiation before surgery.
Ability to read and speak English
See 1 more
Exclusion Criteria
Regular engagement in resistance training (2x/week targeting all major muscle groups)
I have a recent fracture or injury that stops me from safely doing resistance training.
I have a muscle or joint disease affecting my physical ability.
See 3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Exercise Prehabilitation
Participants engage in an exercise program for 5 to 17 weeks, including resistance training sessions twice per week and step count monitoring with a Fitbit device.
5 to 17 weeks
Follow-up
Participants are monitored for retention and improvements in exploratory outcome measures.
Up to 17 weeks
Treatment Details
Interventions
- Exercise (Behavioral Intervention)
Trial OverviewThe study tests an exercise program tailored for patients awaiting esophageal cancer resection. The focus is on whether patients can follow this regimen and how they feel about it.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Exercise prehabilitationExperimental Treatment1 Intervention
In this trial participants will participate in an exercise program for 5 to 17 weeks, varying with treatment plans. Participants will receive resistance training equipment and participate in resistance training sessions twice per week (approximately 30-45 minutes per session). A Fitbit device will be provided to monitor step counts.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Moffitt Cancer CenterTampa, FL
Loading ...
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Trials
576
Patients Recruited
145,000+
References
Effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer: a systematic review and meta-analysis. [2023]To evaluate the effects of unimodal or multimodal prehabilitation on patients undergoing surgery for esophagogastric cancer.
The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship. [2019]The Rehabilitation Strategies in Esophagogastric cancer (RESTORE) randomized controlled trial evaluated the efficacy of a 12-week multidisciplinary program to increase the cardiorespiratory fitness and health-related quality of life (HRQOL) of esophagogastric cancer survivors.
Perceived facilitators and barriers by esophageal cancer survivors participating in a post-treatment exercise program. [2023]Participation in a post-treatment exercise program improves cardiorespiratory fitness and aspects of quality of life for esophageal cancer survivors. For optimal effects, high adherence to the exercise intervention is important. We assessed which facilitators and barriers to exercise adherence are perceived by esophageal cancer survivors, who participate in a post-treatment exercise program.
Perioperative prehabilitation and rehabilitation in esophagogastric malignancies: a systematic review. [2020]Cancers of the esophagus and stomach are challenging to treat. With the advent of neoadjuvant therapies, patients frequently have a preoperative window with potential to optimize their status before major resectional surgery. It is unclear as to whether a prehabilitation or optimization program can affect surgical outcomes. This systematic review appraises the current evidence for prehabilitation and rehabilitation in esophagogastric malignancy. A literature search was performed according to PRISMA guidelines using PubMed, EMBASE, Cochrane Library, Google Scholar, and Scopus. Studies including patients undergoing esophagectomy or gastrectomy were included. Studies reporting on at least one of aerobic capacity, muscle strength, quality of life, morbidity, and mortality were included. Twelve studies were identified for inclusion, comprising a total of 937 patients. There was significant heterogeneity between studies, with a variety of interventions, timelines, and outcome measures reported. Inspiratory muscle training (IMT) consistently showed improvements in functional status preoperatively, with three studies showing improvements in respiratory complications with IMT. Postoperative rehabilitation was associated with improved clinical outcomes. There may be a role for prehabilitation among patients undergoing major resectional surgery in esophagogastric malignancy. A large randomized controlled trial is warranted to investigate this further.
Multimodal Prehabilitation During Neoadjuvant Therapy Prior to Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass and Quality of Life-A Pilot Randomized Clinical Trial. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Neoadjuvant therapy reduces fitness, muscle mass, and quality of life (QOL). For patients undergoing chemotherapy and surgery for esophagogastric cancer, maintenance of fitness is paramount. This study investigated the effect of exercise and psychological prehabilitation on anaerobic threshold (AT) at cardiopulmonary exercise testing (CPET). Secondary endpoints included peak oxygen uptake (peak VO2), skeletal muscle mass, QOL, and neoadjuvant therapy completion.
Physical activity is associated with reduced risk of esophageal cancer, particularly esophageal adenocarcinoma: a systematic review and meta-analysis. [2022]Physical activity has been inversely associated with risk of several cancers. We performed a systematic review and meta-analysis to evaluate the association between physical activity and risk of esophageal cancer (esophageal adenocarcinoma [EAC] and/or esophageal squamous cell carcinoma [ESCC]).
Physical activity, obesity and risk for esophageal adenocarcinoma. [2009]Over the past three decades, an increasing incidence of esophageal adenocarcinoma (EADC) has been reported throughout North America and Europe at a rate exceeding that of any other human solid tumor. Recent studies have clearly implicated chronic gastroesophageal reflux disease and several lifestyle risk factors, including tobacco consumption, diet and obesity, to be associated with increased risk of EADC. Although physical inactivity is now recognized as a risk factor for several chronic diseases including cancer, only a very limited number of studies have specifically evaluated the association between physical activity and esophageal malignancy. Furthermore, the precise biological mechanisms underlying the association between physical activity, obesity and cancer risk remain unclear. Since successful promotion of healthy body weight and exercise may substantially reduce the future incidence of cancer in the population, the purpose of this review is to explore current evidence linking physical activity, obesity and risk of malignancy - specifically EADC.
The effects of prehabilitation on body composition in patients undergoing multimodal therapy for esophageal cancer. [2023]Prehabilitation aims to optimize a patient's functional capacity in preparation for surgery. Esophageal cancer patients have a high incidence of sarcopenia and commonly undergo neoadjuvant therapy, which is associated with loss of muscle mass. This study examines the effects of prehabilitation on body composition during neoadjuvant therapy in esophageal cancer patients. In this cohort study, changes in body composition were compared between esophageal cancer patients who participated in prehabilitation during neoadjuvant therapy and controls who did not receive prehabilitation. Assessment of body composition was performed from CT images acquired at the time of diagnosis and after neoadjuvant therapy. Fifty-one prehabilitation patients and 28 control patients were identified. There was a significantly greater fall in skeletal muscle index (SMI) in the control group compared with the prehabilitation patients (Δ SMI mean difference = -2.2 cm2/m2, 95% CI -4.3 to -0.1, p=0.038). Within the prehabilitation cohort, there was a smaller decline in SMI in patients with ≥75% adherence to exercise in comparison to those with lower adherence (Δ SMI mean difference = -3.2, 95% CI -6.0 to -0.5, P = 0.023). A greater decrease in visceral adipose tissue (VAT) was seen with increasing volumes of exercise completed during prehabilitation (P = 0.046). Loss of VAT during neoadjuvant therapy was associated with a lower risk of post-operative complications (P = 0.017). By limiting the fall in SMI and promoting VAT loss, prehabilitation may have multiple beneficial effects in patients with esophageal cancer. Multi-center, randomized studies are needed to further explore these findings.
Adherence to Pre-operative Exercise and the Response to Prehabilitation in Oesophageal Cancer Patients. [2023]Prehabilitation is thought to reduce post-operative respiratory complications by optimising fitness before surgery. This prospective, single-centre study aimed to establish the effect of pre-operative exercise on cardiorespiratory fitness in oesophageal cancer patients and characterise the effect of adherence and weekly physical activity on response to prehabilitation.
Personalized Prehabilitation Improves Tolerance to Chemotherapy in Patients with Oesophageal Cancer. [2023]Prehabilitation programmes aim to optimise patients before and after cancer treatment including surgery. Previous studies in surgical patients demonstrate that prehabilitation improves pre-operative fitness and overcomes the negative impact of neoadjuvant chemotherapy on fitness. The aim of this study was to assess the impact of prehabilitation on the tolerance of neoadjuvant chemotherapy in patients with oesophageal cancer.
What are the impact and the optimal design of a physical prehabilitation program in patients with esophagogastric cancer awaiting surgery? A systematic review. [2021]Substantial postoperative complications occur after tumor resection for esophagogastric cancers. Physical prehabilitation programs aim to prepare patients for surgery by improving their functional status with the aim of reducing postoperative complications. This systematic review aims to summarize the effects of physical prehabilitation programs on exercise capacity, muscle strength, respiratory muscle function, postoperative outcomes, and health-related quality of life and to determine the optimal design of such a program to improve these outcomes in esophagogastric cancer patients undergoing tumor resection.