Clinical trial NCT01751880: Safety, Feasibility and Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer Patient
Keywords: Gastric cancer, minimally invasive gastrectomy, Physical activity intervention
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy or plans to become pregnant
2. Cognitive disabilities
3. Other primary cancer history
4. History of major abdominal surgery except current surgery
5. Cardiopulmonary medical comorbidity
6. Living \> 60 km from the hospital

Primary outcomes:
measure: 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
timeFrame: 2 weeks and 10 weeks after gastrectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Study officials:
References:
citation: 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.