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NCT Number: NCT02120885

An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yonsei University College of Medicine, Seodaemun-gu, Shinchondong

Seoul, 134, South Korea

About this study

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. Thus, the investigators have done the pilot study about how to practice the exercise program and how to evaluate the effect on the recovery. Based on the result of pilot study which could identify the safety and the feasibility , the investigators would like to do a prospective randomized controlled study to prove the effect of exercise program after surgery

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

physical activity intervention

Behavioral

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.

Primary outcomes

  1. QoL(quality of life)

    Time frame: 10 weeks after gastrectomy

Secondary outcomes

  1. cardiopulmonary function test

    Time frame: 10 weeks after gastrectomy

  2. vital signs reflecting of inflammation level

    Time frame: 10 weeks after gastrectomy

  3. nutrition condition

    Time frame: 10 weeks after gastrectomy

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: Gastric cancer

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 23, 2014
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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