UMIN-CTR Clinical Trial

Public title

Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis

Acronym

Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis

Scientific Title

Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated stomatitis

Scientific Title:Acronym

Prophylactic use of hydrocortisone containing mouthwash in the prevention of mTOR inhibitor-associated 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	Urology	Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The use of targeted agents in the treatment of cancer has recently exploded 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 impact on patient adherence and treatment outcomes. Prevention is most important intervention in the management of stomatitis induced by anticancer therapy, but there are no evidence-based methods for the prevention of stomatitis associated with targeted therapies.In this study, our aim is to establish the effective prevention of oral stomatitis associated with targeted anticancer therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

The incidence of greater than or equal to Grade2 stomatitis in 8 weeks

Key secondary outcomes

Safety of hydrocortisone containing mouthwash adjusted by the drugs approved in Japan. The incidence of stomatitis according to the tumor subtype. The site of stomatitis. The duration and severity of stomatitis

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

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Patients are instructed to swish and expectorate new steroid-containing mouthwash 4 times daily.
Treatment with new steroid-containing mouthwash start on Day 1 of everolimus -based therapy.
Intervention period:8weeks
New steroid-containing mouthwash is composed by diphenhydramine, hydrocortisone, nystatin and tetracycline.

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	Masaya Hattori

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

Homepage URL

Email

mhattori@aichi-cc.jp

Institute

Aichi Cnacer Center

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Department of Gastroenterology, Aichi cancer center
Department of Clinical Oncology, Aichi cancer center
Department of Thoracic Oncology, Aichi cancer center
Department of Head and Neck Surgery, Aichi cancer center
Department of Pharmacy, Aichi cancer center
Faculty of Bioscience and Bioindustry, Tokushima University

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

2016

Year

12

Month

28

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

2016

Year

11

Month

22

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

14

Day

Last follow-up date

2017

Year

11

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

12

Month

26

Day

Last modified on

2018

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029251