Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy.

Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy. - Phase II study of vitamin B12 and folate supplementation for patients undergoing cisplatin plus pemetrexed therapy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006546

Enrollment

Registered

2011-10-14

Start date

2011-10-01

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

Non small-cell lung cancer

Interventions

Vitamin B12 1000 ug, intramuscular, Folate 350 - 500 ug, oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven non-squamous non-small cell lung cancer 2. Planned to undergo CDDP+PEM therapy 3. PS (ECOG) 0-1 4. Sufficient interval from prior treatment 5. Adequate key organ function 6. Life expectancy of at least 12 weeks 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Extensive interstitial pneumonitis 2. Severe complications 3. Active infection 4. History of cytotoxic chemotherapy 5. Active coexistent cancer 6. Need for continuous and systemic administration of corticosteroids 7. Need for continuous and systemic administration of vitamin B12 8. Symptomatic brain metastases 9. Massive pleural effusion or ascites 10. History of irradiation to more than half of pelvic bone 11. Allergy to treatment drugs 12. Pregnant or breast-feeding 13. Unable to take drugs orally 14. Other conditions inadequate for this research

Design outcomes

Primary

Measure	Time frame
Incidence of Grade 3/4/5 neutropenia	—

Countries

Japan

Contacts

Public ContactYusuke Takagi

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Department of Thoracic Oncology

Outcome results

None listed

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