Rehabilitation / nutrition intervention trial for elderly patients with esopha geal cancer

JRCT ID: jRCTs051190016

Registered date:09/05/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 09/05/2019
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Intervention group 1: Rehabilitation intervention i
s performed before or after preoperative chemot
herapy is started. Details are as follows.
Intervention group 2: Rehabilitation / nutrition int
ervention is performed before or after the preope
rative chemotherapy is started. Details are as foll
ows.
(1) Nutrition intervention
In addition to ordinary oral intake, take 2 p (320 kcal / 250 ml) nutritional agent Rehades. If oral in
take is impossible due to stenosis due to the tumor, insertion of a naso ED tube is allowed.
(2) Rehabilitation intervention
Perform a prescribed rehabilitation menu.

Outcome(s)

• Primary Outcome: Muscle mass change rate before and after preoperative chemotherapy

Secondary Outcome

Adverse events of chemotherapy, nutritional indicators (weight, Alb, lymphocyte count), physical f
itness index (grip strength, walking speed), body composition (measured in inbody), perioperative
complications, prognosis (no relapse-free survival, Overall survival time), postsurgical swallowing
function

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

Histologically confirmed primary esophageal ca
ncer. Do not consider organization type. A patien
t scheduled for curative esophageal cancer surg
ery after the operation of preoperative chemothe
rapy.

Exclude criteria

Cases with milk allergy and intolerance.
Cases with active double cancer.
In addition, it is judged that registration in this ex
am is inappropriate.

Related Information

• Primary Sponsor: Hiroshi MIyata