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 2023/12/18 10:15:25

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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

Email

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


Email

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

Email

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

No longer recruiting

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

2023 Year 12 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048768


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name