UMIN-CTR Clinical Trial

Public title

Phase III trial to evaluate EPA-enriched immunonutrition by perioperative Prosure in total gastrectomy for T2-T4a gastric cancer

Acronym

PIII-Prosure

Scientific Title

Phase III trial to evaluate EPA-enriched immunonutrition by perioperative Prosure in total gastrectomy for T2-T4a gastric cancer

Scientific Title:Acronym

PIII-Prosure

Region

Japan

Condition

gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to evaluate whether perioperative administration of ProSure could preserve body weight loss after total gastrectomy for gastric cancer.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

body weight loss at 1 and 3 months after surgery

Key secondary outcomes

Relative performance of ProSure, weight loss of lean body at 1 and 3 months after surgery, the lowest serum albumin level, quality of life, incidence of surgical morbidity and mortality, and incidence of surgical site infection.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral supplementation of 2 packs of ProSure per day for 7 days before surgery and for 21 days after surgery

Interventions/Control_2

No nutritional supplementation was given perioperatively

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

i. Histologically proven adenocarcinoma of the stomach
ii.Clinical T2-T4a and no distant metastasis
iii.R0 resection is possible by open total gastrectomy
iv.Enough oral intake
v.Age ranging between 20 and 80.
vi.ECOG performance status 0-1.
vii.Not cancer of the remnant stomach
viii.Suficient organ functions.
iv.Written informed consent.

Key exclusion criteria

i.Treatment with drug including EPA (ethyl icosapentate)
ii.Synchronous or metachronous cancer (synchronous multiple cancers in the stomach included).
iii.Active inflammation which requires systemic treatment
iv.Hemorrhagic tendency
v.Lactose intolerance
vi.Allergic reaction to milk and soy bean
vii.Uncontrollable diabetes mellitus
viii.Systemic treatment with corticosteroid
ix.Unstable angina or cardiac infarction within 6 months
x.Pulmonary disorder under oxygen
xi.Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy.
xii.Mental disorders which may affect ability or willingness to provide informed consent or abide by the study protocol

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Naoki Hiki

Organization

Cancer Institute Ariake Hospital

Division name

Department of Gastrointestinal Surgery

Zip code

Address

3-8-31 Ariake, Koutou-Ku, Tokyo

TEL

03-3520-0111

Email

naoki.hiki@jfcr.or.jp

Name of contact person

1st name
Middle name
Last name	Takaki Yoshikawa

Organization

Yokohama City University Medical Center

Division name

Department of Gastrointestinal Surgery

Zip code

Address

1-1-2 Nakao, Asahi-ku, Yokohama City, 241-0815, Japan

TEL

045-391-5761

Homepage URL

Email

yoshikawat@kcch.jp

Institute

non-profit organization KSATTS

Institute

Department

Personal name

Organization

non-profit organization KSATTS

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

神奈川県立がんセンター（神奈川県）
がん研有明病院（東京都）
愛知県がんセンター中央病院（愛知県）
大阪府立急性期・総合医療センター（大阪府）
埼玉県立がんセンター（埼玉県）
兵庫医科大学病院（兵庫県）
千葉県がんセンター（千葉県）
国立病院機構大阪医療センター（大阪府）

Date of disclosure of the study information

2011

Year

09

Month

21

Day

URL releasing protocol

None

Publication of results

Published

URL related to results and publications

None

Number of participants that the trial has enrolled

127

Results

al-2017-British_Journal_of_Surgery
Immunonutrition based on an eicosapentaenoic acid-enriched oral diet did not reduce
bodyweight loss after total gastrectomy for gastric cancer compared with a standard diet.

Results date posted

2021

Year

09

Month

29

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Standard diet(n=60) / Standard diet+EPA(n=63)
Age (years):65.6 (30-80) / 65.1 (31-79)
Sex ratio (M : F): 43 : 17 / 46 : 17
Height (cm):163.7/ 160.6
Weight (kg):60.2 / 59.1
Lean body mass (kg):47.0/ 45.7
Albumin (g/dl):4.2 / 4.1
CRP (mg/dl):0.2 /0.3
Tumour location
Upper :36 (60%) /42 (67%)
Middle :24 (41%) /17 (27%)
Lower :0 (0%)/ 4 (6%)
Clinical tumour depth
cT1 16 (27%) / 12 (19%)
cT2 10 (17%) / 13 (21%)
cT3 11 (18%) /12 (19%)
cT4a 23 (38%) / 26 (41%)
Clinical lymph node metastasis
cN0 39 (65%) / 40 (63%)
cN1 12 (20%) / 14 (22%)
cN2 8 (13%) / 7 (11%)
cN3a 1 (2%) / 2 (3%)
Clinical TNM stage
IA 15 (25%) / 12 (19%)
IB 10 (17%) /12 (19%)
IIA 8 (13%) / 7 (11%)
IIB 11 (18%) / 13 (21%)
IIIA 8 (13%) / 12 (19%)
IIIB 7 (12%) / 6 (10%)
IIIC 1 (2%) / 1 (2%)

Participant flow

A total of 127 patients were enrolled, but one patient was rejected after registration. Of the remaining126 patients, 63 were randomized to a standard diet and 63 to a standard diet supplemented with eicosapentaenoic acid.Two patients in the standard diet group with unresectable tumours (peritoneal dissemination) were excluded from the
safety analysis and another patient was excluded from the efficacy analysis as data were missing on bodyweight at enrolment.

Adverse events

None

Outcome measures

Of 127 eligible patients, 126 were randomized; 124 patients (61 standard diet, 63 supplemented diet) were analysed for safety and 123 (60 standard diet, 63 supplemented diet) for efficacy. Across both groups, all but three patients underwent total gastrectomy with Roux-en-Y reconstruction. Background factors were well balanced between the groups. Median compliance with the supplement in the immunonutrition group was 100 per cent before and 54 per cent after surgery. The surgical morbidity rate was 13 per cent in patients who received a standard diet and 14 per cent among those with a supplemented diet. Median bodyweight loss at 1 month after gastrectomy was 8.7 per cent without dietary
supplementation and 8.5 per cent with eicosapentaenoic acid enrichment (P = 0.818, adjusted P = 1.000).
Similarly, there was no difference between groups in percentage bodyweight loss at 3 months (P = 0.529,
adjusted P = 1.000).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

09

Month

12

Day

Date of IRB

2011

Year

09

Month

14

Day

Anticipated trial start date

2011

Year

10

Month

01

Day

Last follow-up date

2019

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

09

Month

21

Day

Last modified on

2021

Year

09

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007536