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Plain-language guide to NCT01194453: phase 2 randomized trial of Cyanocobalamin (Vitamin B12), 288 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01194453
- Phase
- phase 2
- Status
- completed
- Start
- 2009-11
- Completion (planned or actual)
- 2010-09
- Participants
- 288 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Non-small Cell Lung Cancer; Efficacy
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Cyanocobalamin (Vitamin B12).
The investigators want to research some biomarkers that can predict clinical outcomes.
It had two arms (groups): Group A (experimental) and Group B (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 288 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;. With an Eastern CooperativeOncology Group performance status of 0 or 1,. At least 18 years of age. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment.
The full record lists 7 inclusion and 4 exclusion criteria; among the exclusions: peripheral neuropathy \> national cancer institute common toxicity criteria grade 1; progressive brain metastases,; uncontrolled third-space fluid retention before study entry.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.
Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.
It started in 2009-11 with completion listed for 2010-09.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Progression Free Survival (PFS) (time frame: 36months).
It also tracked 1 secondary outcome, for example Response Rate.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in 288 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.
Our Notes on the Compound
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.