A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.

A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer. - A clinical trial of the effect of the elemental diet on adverse events of DCF therapy in patients with esophageal cancer.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007609

Enrollment

Registered

2012-03-30

Start date

2012-03-01

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

esophageal cancer

Interventions

Patients of this trial group will take two packs of the elemental diet (Elental) a day as long as possible after initiation of DCF therapy. When taking two packs is difficult, the dosage of the elem

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The following patients (1) patients with histological squamous cell carcinoma (2) patients in stage II/III/IV (UICC ver.7) (3) patients receiving DCF therapy (DTX750mg/m2,day1), CDDP(75mg/m2,day1), 5-FU(750mg/m2,day1-5) (4) 20<=age of patient <=80years-old (5) patients having PS=0,1,2 (6) patients being able to take the elemental diet (Elental) (7) patients who agreed with written informed consent

Exclusion criteria

Exclusion criteria: The following patients (1) patients considered inadequate for inclusion in this trial by the physician (2) patients with the past history of hypersensitivity to Elental

Design outcomes

Primary

Measure	Time frame
The incidence of gastrointestinal toxicity (grade 2 or higher) during three courses of DCF therapy	—

Secondary

Measure	Time frame
The following are assesed during three courses of DCF therapy, 1) Incidence of adverse events 2) Nutritional condition s(body weght, muscle mass, blood test, urine analysis, N-balance) 3) Quality of Life 4) Response rate	—

Countries

Japan

Contacts

Public ContactChikatoshi Katada

Kitasato University School of Medicine Gastroenterology

ckatada@med.kitasato-u.ac.jp042-778-8111

Outcome results

None listed

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