Pilot study of nutritional intervention by elemental diet for lung cancer during chemotherapy

Pilot study of nutritional intervention by elemental diet for lung cancer during chemotherapy - Pilot study of nutritional intervention for lung cancer during chemotherapy

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007441

Enrollment

Registered

2012-03-06

Start date

2011-02-01

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

Lung cancer

Interventions

We performed nutritional intervention by elemental diet (Elental) in patieints with non-small cell lung cancer and small-cell lung cancer for 16 weeks from first day of the initial chemotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "1)Histologically proven non-squamous non-small cell lung cancer 2)Patient who has measurable lesion by RECIST 3-1)Non-small cell lung cancer: Stage 3B/4 NSCLC 3-2)Small cell lung cancer: extensive small-cell lung cancer 4)ECOG performance status: 0-1 5)Aged>=20 years 6)No chemotherapy, radiotherapy, immunotherapy as prior therapy as for NSCLC 7)Adequate organ functions WBC>= 4000/mm3 & <= 12000mm3 Neutro>=2000/mm3 Platelet >= 100000/mm3 Hemoglobin>= 9.5g/dL GOTand GPT< 2.5*the upper limit of normal Bilirubin<= 2.0mg/dL Serum creatinine<= 1.2mg/dL or 24hr creatinine clearance> 60mL/min PaO2>= 60Torr 8)Life expectancy >= 4months 9)Written informed consent"

Exclusion criteria

Exclusion criteria: " 1)Severe infections 2)Fever of over 38 degrees 3)Serious complications such as cardiac disease, interstitial pneumonia, bleeding diathesis, uncontrollable hypertension or diabetes mellitus 4)History of active double cancer within 5 years 5)Symptomatic brain metastases 6)Pleural effusion or ascites to treat 7)Pericardial effusion 8)Cchickenpox 9)Motor weakness or disorder of peripheral nerve 10)History of drug hypersensitivity 11)Pregnancy 12)History of hypersensitivity against elements of Elental 13)Severe diabetes, and patients suspected abnormal sugar metabolism because of high dosage of steroids 14)Abnormal amino acid metabolism 15)Inappropriate judged by physicians"

Design outcomes

Secondary

Measure	Time frame
Alb, Pre-Alb, Transfferin, QOL, Side effects, Overall survival, Progression free survival, one year survival rate, chemotherapeutical drug, Chemotherapeutical drug compliance	—

Primary

Measure	Time frame
Decrease ratio of body weight	—

Countries

Japan

Contacts

Public ContactKazutoshi Isobe

Toho University Omori Medical Center Department of Respiratory Medicine

kazutoshiisobe@aol.com03-3762-4151

Outcome results

None listed

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