Exploratory randomized controlled trial of cystine-theanine for cancer cachexia

JRCT ID: jRCTs021240010

Registered date:13/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Advanced lung cancer
• Date of first enrollment: 13/06/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): cystine and theanine

Outcome(s)

• Primary Outcome: Change of QOL (FAACT-SEA) from baseline to Day 28
• Secondary Outcome: QOL ( FAACT (A/CS) ) on Day 28, IL-6, Adverse Events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) any gender over 20 years old
2) Diagnosed as lung cancer
3) Eastern Cooperative Oncology Group ( ECOG ) Performance Status 0 - 2
4) With 5 percent weight loss within 6 months and appetite loss, and 2 factors among 3 factors below
(i) fatigue
(ii) systemic muscle weakness
(iii) CRP>0.5 mg/dL or Hb<12 g/dL or serum albumin<3.2 g/dL
5) Adequate organ function within 14 days before registration as below
(i) neutrophil count > 1500 / microlitre
(ii) platelet count > 75000 / microlitre
(iii) Hemoglobin > 8.0 g / dL
(iv) Total bilirubin < 2.0 mg / dL
(v) AST < 100 U / L
(vi) ALT < 100 U / L
(vii) Serum creatinine < 1.5 mg / dL
6) Written informed consent

Exclude criteria

1) Take in a healthy product of amino acids (including protein) or those derived from herb including Saint Jones Wirt except the multivitamin nutritional supplement
2) Planned the chemotherapy with the moderate emetic above-mentioned anticancer agent (ex. Platinum agents, irinotecan, amurubicin, celitinib, crizotinib) during the examination period (one months)
3) Treatment with Anamorelin is planned within the period of this study
4) Impossible oral intake
5) With malabsorption syndrome or active gastrointestinal bleeding or past history of the gastric resection
6) Being pregnant or nursing baby
7) With immunodeficiency or phenylketonuria
8) Withe cognitive impairment such as dementia or delirium
9) With neurologic mental obstacle to affect the data collection
10) Impossible communication because of aphasia, loss of voice, or dysarthria
11) Judged as inappropriate for registration by attending physician

Related Information

• Primary Sponsor: Inoue Akira