UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054719 |
|---|---|
| Receipt number | R000062530 |
| Scientific Title | A Phase II Clinical Trial to Examine the Effectiveness of Perioperative Exercise and Nutritional Therapy in Preventing Skeletal Muscle Mass Loss During Gastrectomy |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2024/09/12 15:52:02 |
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Basic information
Public title
A Study to Examine the Effectiveness of Perioperative Rehabilitation and Nutritional Therapy During Gastrectomy
Acronym
PERIHA study
Scientific Title
A Phase II Clinical Trial to Examine the Effectiveness of Perioperative Exercise and Nutritional Therapy in Preventing Skeletal Muscle Mass Loss During Gastrectomy
Scientific Title:Acronym
PERIHA study
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
With the development of multidisciplinary treatments, the outcomes of gastric cancer treatment have shown a tendency to improve. Even in the modern era of remarkable advances in drug therapy, surgery, specifically gastrectomy, remains the only curative treatment for gastric cancer. However, gastrectomy inevitably leads to postoperative complications, resulting in decreased oral intake, weight loss, and a decline in quality of life (QOL). These impacts on patients are significant.
Sarcopenia negatively affects both short-term and long-term outcomes in many gastrointestinal cancers, including gastric cancer. Due to postoperative complications and the aging population of gastric cancer patients, a certain number of patients develop sarcopenia during the perioperative period of gastrectomy.
After gastrectomy, weight loss and skeletal muscle mass loss are unavoidable due to reduced oral intake and changes in metabolic capacity caused by surgical stress. Therefore, in addition to standard gastric cancer treatment, it is desirable to implement nutritional and exercise therapy from the preoperative period through a certain period postoperatively to minimize skeletal muscle mass loss. Perioperative nutritional and exercise therapy may reduce the risk of sarcopenia and contribute to improved treatment outcomes for gastric cancer.
This study aims to investigate the impact of perioperative nutritional and exercise therapy intervention on the onset of postoperative sarcopenia in patients who are eligible for curative resection and can undergo gastrectomy. Additionally, we aim to verify the effectiveness of comparing the treatment outcomes of the perioperative nutritional and exercise therapy intervention group with historical controls from past treatment outcomes at our institution.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The skeletal mass index at 6 months post-surgery
Key secondary outcomes
Analysis of body composition, QOL evaluation using SF-8, and nutritional status assessment using blood tests during the intervention period up to one year post-surgery
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
In this study, in addition to standard surgical treatment for gastric cancer, perioperative care, and postoperative follow-up, we will implement nutritional therapy (intake of nutritional supplements) for one month before and after surgery, as well as exercise therapy (strength training using TheraBand) from one month before surgery to one year post-surgery.
Nutritional Therapy
Nutritional supplements such as Meiji Balance Mini (200kcal/125ml, Meiji Co., Ltd.) and Isocal (200kcal/100ml, Nestle Japan Co., Ltd.) will be used. Before surgery, patients will consume two bottles per day from the time of case registration until the day before surgery. After surgery, patients will consume one bottle per day from day 7 to day 30 post-surgery. These nutritional supplements will be provided in addition to regular meals. The type of supplement will be selected and adjusted by a nutritionist according to the patient's preferences.
Exercise Therapy
TheraBand will be provided for patients to perform self-directed training at home. A physical therapist will instruct patients on the training menu as shown in the appendix, and patients will perform the exercises at home at least three times a week. There are three types of bands with different contraction abilities, and the physical therapist will set the load and select the appropriate band. Patients will record the details of their training sessions themselves.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with histologically or cytologically confirmed gastric cancer
2. Patients aged 20 years or older at the time of obtaining consent
3. Patients with a disease stage that is expected to be curable by surgery
4. Patients who are either 75 years or older, or have a skeletal muscle index (SMI) of less than 7.8 kg/m2 for males and less than 6.1 kg/m2 for females
5. Patients who have provided written consent of their own free will after fully understanding the details of this study
Key exclusion criteria
1. Patients with concurrent active malignant diseases
2. Patients who cannot undergo body composition analysis using Inbody due to internal metal implants
3. Patients who are unable to take oral intake due to the condition of their gastric cancer
4. Patients deemed inappropriate for participation in this study by the attending physician
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Kato |
Organization
Teine Keijinkai hospital
Division name
Department of Surgery
Zip code
006-8555
Address
1-40, Maeda 1-jo, 12-chome, Teine-ku, Sapporo-shi
TEL
011-681-8111
katoken@qd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Kazufumi |
| Middle name | |
| Last name | Umemoto |
Organization
Teine Keijinkai hospital
Division name
Department of Surgery
Zip code
006-8555
Address
1-40, Maeda 1-jo, 12-chome, Teine-ku, Sapporo-shi
TEL
011-681-8555
Homepage URL
plumk6@gmail.com
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teine Keijinkai Hospital Ethics Committee
Address
1-40, Maeda 1-jo, 12-chome, Teine-ku, Sapporo-shi
Tel
011-681-8111
tkh-rinriml@keijinkai.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062530
