UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010103 |
|---|---|
| Receipt number | 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 13:22:23 |
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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
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
hiroko.shinoda@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011837
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