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Strong for Oesophago-gastric Cancer Surgery - prehabilitation program for people with stomach cancer.

Strong for Oesophago-gastric Cancer Surgery (SOCS): Efficacy of a personalised multidisciplinary enhanced prehabilitation program for patients undergoing oesophagectomy and gastrectomy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000183684
Acronym
SOCS
Enrollment
50
Registered
2023-02-21
Start date
2022-10-03
Completion date
2024-12-19
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The majority of patients undergoing oesophageal/stomach cancer surgery have reduced fitness. This means they are at greater risk for, and struggle to overcome post-surgical complications, which leads to further morbidity and mortality. This study aims to assess whether a prehabilitation exercise and nutrition program administered to participants prior to surgery has any impact on their physical, nutritional and psychological wellbeing after surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with gastric, gastroesophageal junction or oesophageal cancer, you are scheduled to receive or are currently undergoing chemotherapy, radiotherapy or both and you are going to undergo elective surgery to treat your cancer after completing these therapies. Study details All participants who choose to enrol in this study will be given a personalised diet and exercise program to follow for 3 months prior to their elective surgery. During the initial visit, participants will undergo a series of physical assessments to determine their current fitness levels and will be asked to provide a diet history to assess their nutrition status. It is anticipated that this initial assessment will take 60 minutes. After the initial assessment, participants will be given a personalised exercise plan to follow, this will include 2x 45-60 minute one-on-one sessions with a physiotherapist each week for 3 months. Participants will also be asked to undertake additional moderate exercise, e.g. walking, for at least one hour per week for the 3 months. Participants will also be given nutritional advice including suggested meal plans to address target areas (e.g. reducing carbohydrates or increasing protein or vitamin intakes) to follow over the 3 months prior to their surgery. For the 5 days prior to and 5 days after their surgery, participants will also be provided with an immune-modulating supplement (drink) to consume. Participants who are assessed as at risk for anxiety and depression, and those participants who are struggling to comply with their exercise plan will also be offered one-on-one psychological counselling. Data collected from participants who are undergoing these interventions will be compared to historical patients who received standard of care prior to their surgery. It is hoped this research will demonstrate whether a targeted prehabilitation program has a positive effect on the physical, nutritional and mental wellbeing of patients who are undergoing treatment for gastric and oesophageal cancers. If this study does show a positive effect, the prehabilitation program may be expanded to a greater number of cancer patients.

Interventions

A series of assessments related to physical function, diet and mental health will be performed to facilitate a three-month enhanced prehabilitation pre-surgical program that aims to improve physical, nutritional and psychological outcomes in patients with oesophago-gastric cancer. Exercise intervention A three-month optimised aerobic and resistance exercise training intervention, including high-intensity interval training, will be prescribed. All exercise sessions will be approximately 45 to 60

A series of assessments related to physical function, diet and mental health will be performed to facilitate a three-month enhanced prehabilitation pre-surgical program that aims to improve physical, nutritional and psychological outcomes in patients with oesophago-gastric cancer. Exercise intervention A three-month optimised aerobic and resistance exercise training intervention, including high-intensity interval training, will be prescribed. All exercise sessions will be approximately 45 to 60 minutes and occur twice per week and supervised by an accredited exercise physiologist or physiotherapist. The intensity of these exercises will be moderate. Aerobic exercises may include walking on a treadmill or cycling, and resistance exercises may include weight training. The level of intensity will be tailored to the individual and will be assessed using Borg RPE methods by the treating clinician. Attendance will be recorded for each session, and follow-up phone calls to check in for those who do not attend. Each participant will be asked to complete additional, unsupervised exercise training, for example, brisk walking or cycling, for at least 60 minutes per week to meet the current exercise guidelines for individuals with cancer set by the American College of Sports Medicine. Participants' unsupervised exercise training will be monitored weekly by reviewing their exercise training diary. Nutritional intervention Nutrition counselling/support will include an initial assessment, followed by a weekly or fortnightly appointment that will take approximately 30 minutes, to ensure patients meet their nutritional requirements. The nutritionist will discuss the patient weekly food intake and exercise patterns and provide feedback and suggestions around food and drink intake decisions and meal plans and ideas. The frequency of appointments will be determined by the treating dietician. To meet measured energy and predicted protein requirements via nutrition counselling encompassing high energy high, protein diet, food fortification strategies and utilisation of oral nutrition support in patients unable to meet their requirements through diet alone. Consideration of enteral nutrition support if oral intake is less than 60% of requirements despite education & supplementation of the diet. Attendance will be recorded for all nutritional appointments and follow-up calls for those who do not attend. Immune-Modulating supplementation (e.g., IMPACT ®) shall be prescribed as 3 x 200ml tetra packs daily for five days pre & post-operatively, in accordance with evidence-based practice for the nutritional management of patients undergoing upper GI cancer surgery. The supplement contains ingredients including vitamin C and D, zinc, selenium, iron, and protein (including the amino acid glutamine). Adherence and monitoring will occur through frequent interactions with the patients involved in the study including formal appointments, follow up phone calls and informal communication as required. A food diary will also be supported in collaboration with the exercise diary and reviewed with patients at face to face appointments. Psychological intervention The proposed prehabilitation intervention will address the barriers and enablers to complying with the three-month exercise intervention in participants who have been either identified by the Hospital Anxiety and Depression Scale (HADS) cut-off or by the supervising exercise physiologists monitoring the participants. It is important to note that participants who exceed eight or more on the HADS will be automatically referred to the psychological support intervention independent of their compliance/uptake of the exercise intervention. An initial assessment of 60 minutes will be performed for patients eligible for psychological support to determine the frequency of psychology appointments. The frequency of these appointments may be typically weekly, ranging from daily to monthly. Consultations with a psychologist can be face-to-face or in-person; however, this depends on patient preferences. All strategies, such as cognitive behavioural therapy and compliance enhancing techniques will be defined and at the discretion of the treating psychologist, and adherence will be determined by session attendance. Medical optimisation A small proportion of high-risk patients account for the majority of postoperative morbidity. The high-risk clinic aims to identify these patients preoperatively and institute strategies to reduce perioperative morbidity and mortality. This is a standard pre-operative anesthetic assessment clinic for those in preparation for surgery and takes approximately 20 minutes. In most cases only one appointment is required and is conducted face to face wherever possible. Specific aims include assessment of perioperative risk; optimisation of medical comorbidities, analgesia and functional status; and facilitation of informed decision-making and perioperative planning. This involves identifying goals and values unique to the patient, particularly in the event of planned or unplanned high-dependency unit/intensive care admission. All assessments will be completed in person during the operative assessment clinic and completed by an anesthetist. The treating anesthetist will determine the frequency of assessments based on their initial medical evaluation. Most participants will only require one evaluation however some participants may be asked to return again in 3 - 4 weeks time for a repeat assessment

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Any patient with gastric, gastroesophageal junction and oesophageal cancer Scheduled to receive or undergoing neoadjuvant chemotherapy, radiotherapy or both Elective oesophagectomy or gastrectomy following neoadjuvant treatment Age equal to or above 18 years of age

Exclusion criteria

Direct to surgery without neoadjuvant treatment Stage 4 disease as determined by the Upper GI Cancer Multidisciplinary Team Meeting Palliative intent treatment as determined by Upper GI Cancer Multidisciplinary Team Meeting Undergoing local excision of cancer only, by endoscopy or surgery, without a radical lymphadenectomy A neurological, musculoskeletal or cardiopulmonary condition deemed unsafe by the study doctor to participate in the enhanced prehabilitation program.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 3, 2026