PREFOG: Prehabilitation for Gastrectomy

Sponsor
National Cancer Institute, Lithuania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04223401
Collaborator
Vilnius University (Other), Vilnius University Hospital Santaros Klinikos (Other)
128
2
2
46.8
64
1.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prehabilitation
N/A

Detailed 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.

  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Personalized Trimodal Prehabilitation for Gastrectomy
Actual Study Start Date :
Feb 6, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prehabilitation group

Patients in the experimental group will undergo prehabilitation before the elective surgery for gastric cancer.

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

No Intervention: Control group

Patients in the control group will not undergo prehabilitation.

Outcome Measures

Primary Outcome Measures

  1. Postoperative morbidity rate by Clavien-Dindo [At 90 days postoperatively]

Secondary Outcome Measures

  1. Physical status by Spiroergometry [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  2. Physical status by International Physical Activity Questionnaire (IPAQ) [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  3. Postoperative mortality rate [At 30 and 90 days postoperatively]

  4. Nutritional status by albumin level [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  5. Quality of Life by EORTC questionnaires [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  6. 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]

  7. Physical status by grip strength test [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  8. Physical status by 6 minutes walk test [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  9. Physical status by the sit to stand test [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  10. Physical status by the timed up&go test [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

  11. Psychological status by Hospital Anxiety and Depression Scale (HADS). [Baseline, pre-surgery, 3, 6 and 12 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer Institute Vilnius Lithuania 09239
2 Vilnius University hospital Santaros klinikos Vilnius Lithuania

Sponsors and Collaborators

  • National Cancer Institute, Lithuania
  • Vilnius University
  • Vilnius University Hospital Santaros Klinikos

Investigators

  • Principal Investigator: Kestutis Strupas, MD PhD Prof., Vilnius University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Cancer Institute, Lithuania
ClinicalTrials.gov Identifier:
NCT04223401
Other Study ID Numbers:
  • 1
First Posted:
Jan 10, 2020
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022