Prehabilitation for Gastrectomy

Gastric Cancer Clinical Trial

— PREFOG  

Official title:

Personalized Trimodal Prehabilitation for Gastrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04223401
• Other study ID #: 1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: National Cancer Institute, Lithuania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prehabilitation has been demonstrated to be an effective strategy to improve outcomes in patients undergoing some of the abdominal operations. It may increase the physical capacity of the patient, improve postoperative quality of life and even decrease the postoperative morbidity. Currently, the most effective strategy seems to be a trimodal prehabilitation which includes: 1) Nutritional support 2) Psychological support and 3) Physical training.

Description:

This study will investigate personalized trimodal prehabilitation for patients undergoing gastrectomy for gastric cancer.

Prehabilitation group:

Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve:

1. Nutritional intervention: The dietetic physician will perform physical examination and evaluation of the nutritional status to provide individualized care to each patient. Patients will receive personalized recommendations for the prevention or correction of malnutrition.

2. Psychological intervention: Patients will undergo consultation by specialized onco-psychologist. The anxiety and depression level will be evaluated by HAD score and patients will be trained to perform techniques, such as relaxation to reduce and manage anxiety on at home basis.

The psychologist also will enhance patients' motivation to comply with the exercise and nutritional aspects of the intervention.

3. Exercise intervention: Patients will be consulted by PM&R physicians and physiotherapists and personalized exercise plans will be developed according to the results of 6MWT, AT and VO2peak. Exercises will focus on skeletal muscles and cardiopulmonary function training and the exercises feasible at home basis will be selected. All patients will undergo three supervised training sessions to learn the correct exercise techniques.

All patients will be routinely contacted to ensure compliance with prehabilitation program.

Patients scheduled for surgery first by multidisciplinary tumor board will undergo 4 weeks prehabilitation program, while patients scheduled for perioperative chemotherapy will undergo prehabilitation while neoadjuvant treatment will be administered.

Control group:

Patients will also undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before surgery or before and after neoadjuvant chemotherapy. Patients will not undergo prehabilitation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient = 18 years old

• Patient agrees to participate in a clinical study

• Patient requires surgical treatment for gastric cancer

Exclusion Criteria:

• Patient requiring surgical treatment for recurrent gastric cancer

• Patient condition not allowing to postpone surgery for at least 4 weeks

• Patients physical or mental condition which will not allow the patient to participate in prehabilitation program

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Other:
• Prehabilitation
Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve: Nutritional intervention Psychological intervention Exercise intervention

Locations

Country	Name	City	State
Lithuania	National Cancer Institute	Vilnius
Lithuania	Vilnius University hospital Santaros klinikos	Vilnius

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Institute, Lithuania	Vilnius University, Vilnius University Hospital Santaros Klinikos

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morbidity rate by Clavien-Dindo		At 90 days postoperatively
Secondary	Physical status by Spiroergometry		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Physical status by International Physical Activity Questionnaire (IPAQ)		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Postoperative mortality rate		At 30 and 90 days postoperatively
Secondary	Nutritional status by albumin level		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Quality of Life by EORTC questionnaires		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Percentage of patients reaching the complete oncological treatment fixed in a multidisciplinary tumour board (including preoperative chemotherapy, surgery and postoperative chemotherapy)		12 months after surgery
Secondary	Physical status by grip strength test		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Physical status by 6 minutes walk test		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Physical status by the sit to stand test		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Physical status by the timed up&go test		Baseline, pre-surgery, 3, 6 and 12 months after surgery
Secondary	Psychological status by Hospital Anxiety and Depression Scale (HADS).		Baseline, pre-surgery, 3, 6 and 12 months after surgery