UMIN-CTR Clinical Trial

Public title

"This study on the preventive management of stomatitis due to everolimus treatment with steroid-containing mouthwash" examines the causal relationship between drug metabolizing enzyme and onset of stomatitis.

Acronym

"This study on the preventive management of stomatitis due to everolimus treatment with steroid-containing mouthwash" examines the causal relationship between drug metabolizing enzyme and onset of stomatitis.

Scientific Title

"This study on the preventive management of stomatitis due to everolimus treatment with steroid-containing mouthwash" examines the causal relationship between drug metabolizing enzyme and onset of stomatitis.

Scientific Title:Acronym

"This study on the preventive management of stomatitis due to everolimus treatment with steroid-containing mouthwash" examines the causal relationship between drug metabolizing enzyme and onset of stomatitis.

Region

Japan

Condition

Renal cell carcinoma, Neuroendcrine tumors of pancreatic,lung and gastrointsitinaltract, Breast cancer

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Pneumology
Breast surgery	Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The use of targeted agents in treating cancer has recently increased and has had a significant positive impact on survival. However, targeted anticancer therapies can also cause significant toxicities. Stomatitis is one of the most commonly reported toxicities of targeted agents and can influence patient adherence and treatment outcomes. Prevention is the most important intervention in managing stomatitis induced by anticancer therapy. This study aimed to investigate the causal relationship between drug metabolizing enzyme and onset of stomatitis and to determine its preventive management.

Basic objectives2

Others

Basic objectives -Others

In this study, "the prophylactic use of hydrocortisone-containing mouthwash in preventing mTOR -inhibitor-associated stomatitis" UMIN ID000025408 (2016.12.28)
is included.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The incidence is > Grade 2 stomatitis in 8 weeks.

Key secondary outcomes

Relationship between stomatitis and drug metabolizing enzymes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Maneuver

Interventions/Control_1

When a registered patient visits a dental clinic, the dentist collects oral mucus from the oral mucosal surface using a sterilized swab at days 0, 14, and 28.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of Pancreus, GI or lung origin
2.Pathologically confirmed advanced or metastatic renal cell carcinoma
3.Pathologically confirmed advanced or metastatic ER-positive and HER2-negatice breast cancer
4.ECOG performance status 0 or 1
5.Adequate bone marrow, liver and renal function
6.Informed consent is obtainable from the subject herself in documented form using the Consent Form

Key exclusion criteria

1.Occurrence of oral mucositis within 1 month prior to randomization
2.Previous mTOR inhibitor treatment (everolimus, etc.)
3.Interstitial pneumonia or pulmonary fibrosis
4.Received drug treatment known to have a strong inhibitory or inductive effect on the cytochrome P450 (CYP) 3A isozymes (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin)
5.Detection level of HBV-DNA
6.HCV infection or a history of HCV infection
7.History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation
8.Multiple active cancers (homochronous multiple cancers, or heterochronous multiple cancers with a cancer-free period of less than 5 years prior to randomization)
Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer
9.Brain metastasis that requires treatment for intracranial hypertension or emergency irradiation of the brain
10.Pleural effusion, ascites, or pericardial effusion that requires emergency treatment
11.Concurrent and active infectious disease
12.With uncontrolled diabetes mellitus or currently receiving insulin therapy
13.Difficulty to participate in this study due to mental illness or psychiatric symptoms
14.With another reasons recognized as inadequate to participate in this study by doctors

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hiroji Iwata

Organization

Aichi Cancer Center

Division name

Department of Breast Oncology

Zip code

Address

1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref

TEL

052-762-6111

Email

hiwata@aichi-cc.jp

Name of contact person

1st name
Middle name
Last name	Michiko Tatematsu

Organization

Aichi Cancer Center

Division name

Department of Pharmacy

Zip code

Address

1-1 Kanokoden Chikusa-ku, Nagoya, Aichi-pref

TEL

052-762-6111

Homepage URL

Email

mtatema@aichi-cc.jp

Institute

Department of Head and Neck Surgery,
Pharmacy,Aichi cancer center
Faculty of Pharmaceutical Sciences Suzuka University of MedicalScience
Faculty of Bioscience and Bioindustry,Tokushima University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

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

愛知県がんセンター中央病院（愛知県）

Date of disclosure of the study information

2017

Year

08

Month

01

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

Terminated

Date of protocol fixation

2017

Year

03

Month

03

Day

Date of IRB

Anticipated trial start date

2017

Year

03

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

07

Month

06

Day

Last modified on

2018

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032179