Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed.

Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed. - Phase II study of vitamin B12 and folate supplementation for patients undergoing chemotherapy with pemetrexed.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010570

Enrollment

140

Registered

2013-04-30

Start date

2013-04-30

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, Malignant pleural mesothelioma

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 or malignant pleural mesothelioma 2. Planned to undergo pemetrexed-based therapy 3. PS (ECOG) 0-2 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. Allergy to treatment drugs 5. Pregnant or breast-feeding 6. Unable to take drugs orally 7. Other conditions inadequate for this research

Design outcomes

Primary

Measure	Time frame
The incidence of grade 3/4/5 non-hematologic toxicities	—

Secondary

Measure	Time frame
Other toxicities, Response rate, Progression-free survival	—

Countries

Japan

Contacts

Public ContactKageaki Watanabe

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Department of Thoracic Oncology & Respiratory Medicine

kageakiwatanabe@cick.jp03-3823-2101

Outcome results

None listed

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