UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Takashi Tsuda
Organization	St. Marianna University School of Medicine
Division name	Clinical Oncology
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	Hiroko Minatogawa
Organization	St. Marianna University School of Medicine Hospital
Division name	Department of pharmacy
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 01 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011837