UMIN-CTR Clinical Trial

Public title

Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.

Acronym

Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.

Scientific Title

Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.

Scientific Title:Acronym

Evaluation of efficacy of improved nutrition for patients with head and neck cancer underwent oral nutritional supplements.

Region

Japan

Condition

Head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate a correlation between the dosage of enteral nutrition formula and body weight reduction rate, and effect of nutritional supplement consumption for patients with head and neck cancer. To analyze a relationship between the change rate of each body composition factor and the adverse events as a secondary endpoint.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Rate of change of body weight.
Dose of oral nutritional supplements per body weight.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

RACOL-NF Liquid for Enteral Use

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Patients who will receive any one of the following 3 therapies: chemotherapy, radiation therapy, or chemoradiotherapy.
2.Patients who have been diagnosed and informed of diagnosis with head and neck cancer.
3.Patients who have been judged to be a candidate of oral intake by the investigator.
4.Patients aged 20 years old and older and 75 years old and under.
5.Patients and legal representative who have given voluntary written informed consent.

Key exclusion criteria

1.Patients who have a history of hypersensitivity to enteral nutritional supplements.
2.Patients with ileus.
3.Patients without an enteric function.
4.Patients with severe liver failure and/or renal failure.
5.Patients with abnormal glucose metabolism such as severe diabetes.
6.Patients with inborn error of amino acid metabolism.
7.Patients who had blood transfusion within one month.
8.Patients with active infection.
9.Patients with severe organ failure.
10.Patients who have edema at the time of registration.
11.Patients with electric implantable devices such as pacemakers.
12.Patients who are pregnant, suspected to be pregnant or breastfeeding.
13.Patients judged to be inappropriate for the study by the investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyuki Tsuji

Organization

Kanazawa Medical University

Division name

Department of Otorhinolaryngology-Head and Neck Surgery

Zip code

Address

1-1 Daigaku Uchinada Kahoku Ishikawa

TEL

076-286-2211

Email

tsujih-i@kanazawa-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Kanako Teraguchi

Organization

Kanazawa Medical University

Division name

Department of Otorhinolaryngology-Head and Neck Surgery

Zip code

Address

1-1 Daigaku Uchinada Kahoku Ishikawa

TEL

076-286-2211

Homepage URL

Email

kanako-y@kanazawa-med.ac.jp

Institute

Kanazawa Medical University

Institute

Department

Personal name

Organization

Kanazawa Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

Date of disclosure of the study information

2012

Year

11

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

08

Month

15

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

17

Day

Last modified on

2015

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010980