An Exploratory study on safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy

An Exploratory study on safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy - Safety and tolerability of hydration using oral rehydration solution during cisplatin chemotherapy(ALCT002)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007887

Enrollment

Registered

2012-05-08

Start date

2012-05-01

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 patients planned to receive two or more cycles of cisplatin chemotherapy

Interventions

hydration using intravenous solution (chemotherapy days 2 and 3) Hydration using oral rehydration solution (chemotherapy days 2 and 3)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically or cytrologically confirmed diagnosis of lung cancer 2. Patients planned to receive two or more cycles of cisplatin chemotherapy 3. Patients aged between 20 and 74 years 4. Patients with ECOG Performance status of 0 to 2 5. Patients expected to survive longer than at least three months 6. Patients who can be treated after hospitalization 7. Patients who provide written informed consent 8. Patients who have never been treated with cisplatin previously

Exclusion criteria

Exclusion criteria: 1. Patients with the serum creatinine level exceeding the upper limit of the hospital or with the estimated Ccr of 60mL/min or lower 2. Patients with intractable ascites or pleural effusion except those who have been treated by pleurodesis. 3. Patients with psychiatric disease or psychological symptom 4. Female patients of childbearing potential, pregnancy, or lactation 5. Patients with poorly controlled diabetes 6. Patients who meet the criteria specified in "contraindication" or "careful administration" in the package inserts of the intravenous solutions used in the study 7. Patients with difficulty eating or with grade 2 or higher anorexia (CTCAE 4.0) 8. Patients otherwise deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigator

Design outcomes

Primary

Measure	Time frame
serum creatinine	—

Secondary

Measure	Time frame
serum cystatinC serum beta2-microglobulin serum BUN urine volume urine sodium urine NAG urine beta2-microglobulin creatinine clearance	—

Countries

Japan

Contacts

Public ContactTakuma Yokoyama

Kyorin Univercity Hospital Department of Respiratory Medicine

taku@ks.kyorin-u.ac.jp0422-47-5511

Outcome results

None listed

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