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

Not Applicable

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000010103
• Lead Sponsor: St. Marianna University School of Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-01
• Study Completion: 2016-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)