UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000010103
Receipt No. R000011837
Scientific Title Open-label trial to evaluate the efficacy of pre-emptive therapy with minocycline and multidisciplinary intervention for skin toxicity of anti EGFR antibody in colorectal cancer patient
Date of disclosure of the study information 2013/04/01
Last modified on 2018/02/28

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Basic information
Public title Open-label trial to evaluate the efficacy of pre-emptive therapy with minocycline and multidisciplinary intervention for skin toxicity of anti EGFR antibody in colorectal cancer patient
Acronym Pre-emptive therapy with minocycline and multidisciplinary intervention for skin toxicity of anti EGFR antibody
Scientific Title Open-label trial to evaluate the efficacy of pre-emptive therapy with minocycline and multidisciplinary intervention for skin toxicity of anti EGFR antibody in colorectal cancer patient
Scientific Title:Acronym Pre-emptive therapy with minocycline and multidisciplinary intervention for skin toxicity of anti EGFR antibody
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of pre-emptive therapy with minocycline for skin toxicity of anti EGFR antibody in colorectal cancer patient.
The other purpose is to evaluate the validity of multidisciplinary intervention and pharmacist managed protocol for skin toxicity of anti EGFR antibody.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The incidence of >= Grade 2 skin toxicity (Dermatitis acneiform, Paronychia, Dry skin, Pruritus) during 4weeks after starting anti EGFR antibody (using CTCAE v4.0)
Key secondary outcomes 1) The degree of skin toxicity after finishing pre-emptive therapy with minocycline (at week 4 to 8 after starting anti EGFR antibody)
2) QOL score (Dermatology Life Quality Index) at starting, week 4 and 8
3) The incidence to change and add medications for skin toxicity by doctor which pharmacists prescribe
4) The incidence of inconsistency between doctors evaluation for skin toxicity and pharmacists
5) The adherence of skin toxicity self-management by patient (check every week until week4, week6 and 8)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Minocycline tablet 100mg once a day after dinner
(for 4 weeks after the day starting to take anti EGFR antibody)
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with colorectal cancer taking anti EGFR antibody for the first time. (regardless of combination with cytotoxic agency or anti EGFR alone and treatment line)
2) Patients >=20 years old who can be obtained informed consent.
3) ECOG (Eastern Cooperative
Oncology Group) PS (performance
status) of 0, 1 or 2
4) Patients who have intact bone marrow, liver, and renal function
5) Patients with more than three months of life expectancy
6) All subjects must be provided written informed consent prior to entry
Key exclusion criteria 1) Patients with brain metastasis
2) Patients who have dementia or mental disorder
3) Patients who have dermatological disorder needed medication prescribed by dermatologist
4) Patients who have >= Grade 2 skin toxicity before entry (using CTCAE v4.0)
5) Patients who concurrently take Capecitabine and anti EGFR antibody
6) Patients taking systemic
corticosteroid (inhaled, eye-drop and nasal drip steroid are allowed).
7) Patients with a history of administration of anti EGFR antibody
8) Patients who had a hypersensitivity reaction to minocycline or anti EGFR antibody
9) Patients who are intolerant with chemotherapy
10) Patients or their family who cannot manage patients skin care, evaluate the degree of skin toxicity or mark answer sheets.
11) Pregnant, breastfeeding , sexually active woman, or patients with no contraception.
12) HBs positive
13) Patients with active infection
14) Patients who are inappropriate to enter the trial with any safety reasons, judged by the primary doctors or investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Tsuda
Organization St. Marianna University School of Medicine
Division name Clinical Oncology
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa
TEL 044-977-8111
Email hiroko.shinoda@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Minatogawa
Organization St. Marianna University School of Medicine Hospital
Division name Department of pharmacy
Zip code
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa
TEL 044-977-8111
Homepage URL
Email hiroko.shinoda@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine Hospital
Institute
Department

Funding Source
Organization St. Marianna University School of Medicine Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 聖マリアンア医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2016 Year 02 Month 01 Day
Date of closure to data entry
2016 Year 02 Month 01 Day
Date trial data considered complete
2016 Year 02 Month 01 Day
Date analysis concluded
2016 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 23 Day
Last modified on
2018 Year 02 Month 28 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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