SHIVILE study

Not Applicable

• Conditions: on Small Cell Lung Carcinoma

• Registration Number: JPRN-jRCTs021200031
• Lead Sponsor: agashima Hiromi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-15
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.The age at the time of obtaining consent is 18 years or older
2.Patients with cytopathological or clinical diagnosis of non-small cell lung cancer
3.Cases where surgical treatment, definitive radiation therapy, and chemoradiation therapy are not indicated (excluding palliative irradiation)
4.Patients scheduled to be treated by the treatment including paclitaxel
5.Patients scheduled to treated by carboplatin+paclitaxel therapy (batch) or carboplatin+paclitaxel (batch) +pembrolizumab therapy
(or patients with Grade 2 or higher (CTCAE ver5.0.) CIPN by split paclitaxel)
6.Patients who are not recieving anti-ulcer drugs or are receiving anti-ulcer drugs but are considered to be able to change to lafutidine
7.Patients who can ingest orally
8.Patients who can recieve informed consent

Exclusion Criteria

1.Patients who receive paclitaxel as chemoradiotherapy
2.Patients who are pregnant or breastfeeding
3.Patients with a history of drug hypersensitivity or allergy to lafutidine
4.Patients with a history of drug hypersensitivity or allergy to paclitaxel
5.Patients with contraindications reg arding paclitaxel administration, such as those with a history of hypersensitivity to polyoxyethylene castor oil-containing preparations (eg, cyclosporine injection) or severe myelosuppression
6.Patients with a history of severe drug hypersensitivity to other drug s
7.Patients who have already taken anti-ulcer drugs and cannot chang e to lafutidine
8.Patients who cannot judg e subjective symptoms related to peripheral neuropathy due to sympto
ms by brain metastasis or neuropathy
9.Patients originaly had Grade2(CTCAE ver5.0.) or higher peripheral neuropathy
10.Patients judg ed to be inappropriate by doctor to safely carry out this reserch

Study & Design

• Study Type: Interventional
• Study Design: Not specified