SHIVILE study

JRCT ID: jRCTs021200031

Registered date:15/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non Small Cell Lung Carcinoma
• Date of first enrollment: 18/01/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): 20 patients in the intervention group/20 patients in the control group.In the intervention group, raftidine 10mg tablets will be taken twice a day in the after breakfast and after dinner.In the control group, nothing will be taken.

Outcome(s)

• Primary Outcome: Common Terminology Criteria for Adverse Events(CTCAE) version 5.0.: Grade 2 or higher peripheral neuropathy

Secondary Outcome

Common Terminology Criteria for Adverse Events(CTCAE)version 5.0:Grade 3 or higher peripheral neuropathy
Peripheral neuropathy score distribution in the Patient Neurotoxicity Questionnaire (PNQ)
Peripheral neuropathy score distribution in the Functional Assessment of Cancer Therapy-neurotoxicity(FACT/GOG-Ntx)
Time from the first cycle therapy of paclitaxel to the appearance of peripheral neuropathy
Rate of dose reduction / discontinuation of paclitaxel due to adverse events
Progression Free Survival,PFS
Response Rate,RR
Safety(occurrence of adverse events)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Maemondo Makoto