colorectal cancer
Conditions
Interventions
Minocycline tablet 100mg once a day after dinner (for 4 weeks after the day starting to take anti EGFR antibody)
Sponsors
St. Marianna University School of Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of >= Grade 2 skin toxicity (Dermatitis acneiform, Paronychia, Dry skin, Pruritus) during 4weeks after starting anti EGFR antibody (using CTCAE v4.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactHiroko Minatogawa
St. Marianna University School of Medicine Hospital Department of pharmacy
Outcome results
None listed