RICH study
- Conditions
- anorexia
- Registration Number
- JPRN-jRCT1080222695
- Lead Sponsor
- Tsumura & Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 60
1) Patients with histological or cytological confirmation of lung cancer
2) Patients who are scheduled to undergo chemotherapy including cisplatin
3) Patients who are intolerant to oral administration of test drugs
4) Patients with ECOG performance status of 0- 1
1) Patients who had used Japanese herbal (Kampo) medicines within 2 weeks before registration.
2) Patients who are planned administration amount of cisplatin dosage 20 mg/m2 or under.
3) Patients who are receiving chemotherapy with cisplatin containing regimen.
4) Patients with hemoptysis of 2.5mL/day or more within 2 weeks of registration
5) Patients with peripheral neuropathy, CTCAE Grade1 or more.
6) Patients with symptomatic brain metastasis.
7) Patients with a systemic inflammatory condition or serious infection.
8) Patients with serious complication (heart disease, interstitial pneumonia, uncontrolled diabetes)
9) Patients with uncontrolled ascites, pleural effusion or pericardial effusion.
10) Patients with other active malignancies or a history of other malignancies.
11) Patients with history of serious allergic reactions to drugs.
12) Women who are pregnant,might be pregnant or lactating or planning a pregnancy
13) Patients who are considered inappropriate by investigator/subinvestigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change in amount of food intake
- Secondary Outcome Measures
Name Time Method The change in QOL questionnaires (QLQ-C30 & QLQ-LC13) score