NCT01751880

Brief Summary

Gastric cancer is a major health issue and one of the most common malignance in Korea. With the popularization of cancer screenings and increasing the average lifespan, the number of gastric cancer patients is increased. In the past, most of the research were concerned with survival and recovery after cancer surgery. However, as the medical technology had been developed and recovery rate and survival rate of cancer patients had risen, the patients wanted to return to a daily life and desire for participation for leisure. In other words, the patients who underwent surgery wants to maintain a high quality of life(QOL) level as like prior to cancer surgery. There are many reports on the effect of the exercise program after cancer surgery. In addition, exercise program was associated with improving the QOL and functional recovery, decreasing a mood of depression, maintaining a muscle mass and improving the survival rate. However, the subject patients of previous studies were Western people. Therefore, The results were not disclosed whether the exercise program suited to the body characteristics of Korean people. Furthermore there was no exercise program studies for the gastric cancer patients. Medical service for cancer patients care should include not only diagnosis, treatment as like surgery but efforts on enhancing the quality of life. In other words, post-management education and management program as like exercise program are necessary for the cancer patients after surgery. So, the research about how to practice the exercise program and how to evaluate the effect on the recovery is needed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2013

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

December 12, 2012

Last Update Submit

November 26, 2017

Conditions

Gastric Cancer Patient

Keywords

Gastric cancer, minimally invasive gastrectomy, Physical activity intervention

Outcome Measures

Primary Outcomes (1)

  • changes of result of blood sample test, cardio pulmonary function test and vital signs reflecting of inflammation level and nutrition condition in patients with minimally invasive gastrectomy

    2 weeks and 10 weeks after gastrectomy

Study Arms (1)

Exercise Group

EXPERIMENTAL
Behavioral: physical activity intervention

Interventions

physical activity interventionBEHAVIORAL

Exercise program is scheduled to be conducted in three phases. Phase I is in-hospital exercise program. This program will be conducted in hospital during 1 week after surgery. Phase II is home-exercise program that will be performed at home during 1 week after discharge. Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program. Main-exercise program is focused on the functional recovery.

Exercise Group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Early gastric cancer patients
  • Undergoing minimally invasive surgery
  • AGE: 20-70
  • ECOG: 0-1
  • A patient who did not exercise regularly for the last 6 months
  • A patient who signed the informed consent

You may not qualify if:

  • Pregnancy or plans to become pregnant
  • Cognitive disabilities
  • Other primary cancer history
  • History of major abdominal surgery except current surgery
  • Cardiopulmonary medical comorbidity
  • Living \> 60 km from the hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine, Seoul, Korea

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Cho I, Son Y, Song S, Bae YJ, Kim YN, Kim HI, Lee DT, Hyung WJ. Feasibility and Effects of a Postoperative Recovery Exercise Program Developed Specifically for Gastric Cancer Patients (PREP-GC) Undergoing Minimally Invasive Gastrectomy. J Gastric Cancer. 2018 Jun;18(2):118-133. doi: 10.5230/jgc.2018.18.e12. Epub 2018 Apr 25.

    PMID: 29984062DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2012

First Posted

December 18, 2012

Study Start

August 8, 2012

Primary Completion

November 5, 2013

Study Completion

November 5, 2013

Last Updated

November 28, 2017

Record last verified: 2017-11

Locations

KR(1)