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Exploratory randomized controlled trial of cystine-theanine for cancer cachexia

An exploratory randomized controlled trial of cystine-theanine for cancer cachexia - An exploratory randomized controlled trial of cystine-theanine for cancer cachexia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021240010
Enrollment
50
Registered
2024-06-13
Start date
2024-07-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced lung cancer

Interventions

cystine and theanine

Sponsors

Inoue Akira
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Change of QOL (FAACT-SEA) from baseline to Day 28

Secondary

MeasureTime frame
QOL ( FAACT (A/CS) ) on Day 28, IL-6, Adverse Events

Contacts

Public ContactAkira Inoue

Tohoku University Hospital

akira.inoue.b2@tohoku.ac.jp+81-22-717-7366

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026