Clinical trial NCT02120885: An Effect of an Individualized Physical Activity Intervention for Gastric Cancer Patient Undergoing Minimally Invasive Gastrectomy: a Phase III, Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: Gastric cancer
minimally invasive gastrectomy
Physical activity intervention
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.

Detailed description: 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

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: QoL(quality of life)
timeFrame: 10 weeks after gastrectomy
Secondary outcomes:
measure: cardiopulmonary function test
timeFrame: 10 weeks after gastrectomy
measure: vital signs reflecting of inflammation level
timeFrame: 10 weeks after gastrectomy
measure: nutrition condition
timeFrame: 10 weeks after gastrectomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Seodaemun-gu, Shinchondong
Study officials:
References: