UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042743 |
|---|---|
| Receipt number | R000048768 |
| Scientific Title | Perioperative nutrition support and exercise for preventing skeletal muscle loss in patients with esophageal cancer undergoing esophagectomy; a prospective study. |
| Date of disclosure of the study information | 2020/12/14 |
| Last modified on | 2024/06/17 10:55:41 |
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Basic information
Public title
Perioperative nutrition support and exercise for preventing skeletal muscle loss in patients with esophageal cancer undergoing esophagectomy; a prospective study.
Acronym
Perioperative nutrition support and exercise for preventing skeletal muscle loss in patients with esophageal cancer undergoing esophagectomy; a prospective study.
Scientific Title
Perioperative nutrition support and exercise for preventing skeletal muscle loss in patients with esophageal cancer undergoing esophagectomy; a prospective study.
Scientific Title:Acronym
Perioperative nutrition support and exercise for preventing skeletal muscle loss in patients with esophageal cancer undergoing esophagectomy; a prospective study.
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the safety and efficacy of perioperative nutrition support and exercise for preventing postoperative skeletal muscle loss in patients with esophageal cancer undergoing esophagectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in skeletal muscle mass in thigh CT from registration to 4 weeks after surgery
Key secondary outcomes
1. Change in skeletal muscle mass in Bioelectrical Impedance Analysis / abdominal CT from registration to 4 weeks after surgery
2. Change in skeletal muscle mass in Bioelectrical Impedance Analysis / abdominal and thigh CT from registration to before surgery and from registration to 12 weeks after surgery
3. postoperative complications
4. following items in time of registration, before surgery, 4weeks after, 12 weeks after, 24 weeks after and 48 weeks after surgery.
physical function (body weight, grip strength, gait speed, stand and sit test, Knee extension muscle strength, and 6MWD.
nutrition index(CONUT score, calorie intake)
amount of exercise(IPAC, physical activity)
questionnaire (FIM, QLQC30, Cancer fatigue scale)
completion rate of intervention
adverse events (joint pain, fracture, fall, bowel obstruction, diarrhea)
5. following items 4weeks, 12weeks, 24 weeks and 48weeks after surgery
obstruction of feeding tube
complication associated with feeding tube
6. vitamin D at registration, before surgery and 4 weeks after surgery.
7. tumor micro environment of resected specimen
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
before surgery
Provide nutritional guidance such as required energy and protein content. Prescribe aerobic exercise and resistance training.
surgery
esophagectomy, which is the standard treatment for esophageal cancer, is performed. Gastric tube reconstruction is performed, and an enteral feeding tube is placed.
Early postoperative period
Administer nutrition using the enteral feeding tube early after surgery. At the same time, perform an early postoperative exercise program
Postoperative recovery Hospitalization period
After starting oral intake, the amount of enteric nutrition was adjusted according to the amount of oral intake. Prescribe aerobic exercise and resistance training excluding abdominal muscle training.
Postoperative home period (discharge to 28 days after surgery)
the amount of enteric nutrition was adjusted according to the amount of oral intake. prescribe aerobic exercise and resistance training, including abdominal muscle training. If hospitalization continues on the 28th day after surgery, this period does not exist.
Amino acid intake continues throughout the intervention period
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. histologically proven esophageal cancer such as squamous cell carcinoma and adenocarcinoma.
2. scheduled to undergo esophagectomy, which is the standard treatment for esophageal cancer
3. esophagectomy can be scheduled about 21 (15 to 30) days after starting intervention.
4. gastric tube reconstruction and placement of enteral feeding tube are scheduled
5. age 20 to 80 years old
6. Eastern cooperative oncology group performance status 0 or 1
7. ADL(FIM) score is 120 or more.
8.possible to confirm body weight before 6 month (patient declaration, etc.)
9. someone (family members or healthcare professionals, supporters, etc.) can observe the patient's condition throughout the study period.
10. no severe organ failure (bone marrow, heart, lungs, liver, kidneys, etc.) and clinical findings or tests at the start of the intervention meet the following criteria:
Hemoglobin: 8.0 g / dL or more
Total bilirubin: 2.0 mg / dL or less
AST, ALT: 150 IU / L or less
eGFR 45 mL / min / 1.73m2 or more
Resting indoor air SpO2: 90% or more, or PaO2: 60 Torr or more
Resting heart rate: <120 beats / minute
CRP: <5.0 mg / dL
11. written informed consent was obtained from the patient
Key exclusion criteria
1.patients who had past history of treatment for esophageal cancer
2.patients who were treated for other cancer within 1 year before registration.
3. Patients with active double cancer who are expected to require surgery, chemotherapy, or radiation therapy within 3 months of the date of consent.
4. Patients who are judged to be difficult to undergo intervention due to heart disease, osteoarthritis, neurological disease, etc.
5. Patients with psychosis or psychiatric symptoms who are judged to have difficulty in participating in this trial
6. Patients who have difficulty with adequate food, oral intake of oral preparations, and digestion and absorption (patients with chronic nausea, vomiting or gastrointestinal obstruction, etc.)
7. Patients who had myocardial infarction or unstable angina within 6 months of study enrollment
8. Patients with uncontrolled hypertension and persistent arrhythmias despite appropriate treatment (although patients with stable chronic atrial fibrillation receiving stable anticoagulant therapy are acceptable) (Patients who have pacemaker are excluded)
9. Diabetic patients who are or will be taking insulin. uncontrolled diabetics despite proper treatment.
10. Patients with heart failure, respiratory failure, liver failure
11. Patients who are judged to be inappropriate in intervention for reasons other than the above
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | kazutaka |
| Middle name | |
| Last name | obama |
Organization
Kyoto university
Division name
Department of surgery
Zip code
606507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757513650
kobama@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Ueno |
Organization
Kyoto University
Division name
Department of surgery
Zip code
6068507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
0753667595
Homepage URL
k_ueno@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university graduate school and faculty of medicine, ethics committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2020 | Year | 12 | Month | 14 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048768
