Clinical trial · Interventional
Study to Investigate the Therapeutic Role of RNA Fragments in Platelet Production During Chemotherapy
Phase II Dose of Escalation Design to Investigate the Therapeutic Role of RNA Fragments in the Protection of Platelet Production During Chemotherapy
NCT01163110CI-TRIAL-00012650completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to measure the therapeutic potential of Escherichia coli (E. coli) and yeast ribosomal Ribonucleic acid (RNA) fragments to maintain the production of platelets in patients undergoing cytotoxic therapy for cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Realbuild | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine whether E. coli or yeast ribosomal ribonucleic acid (rRNA) fragments prophylactically prevent the development of thrombocytopenia during chemotherapy.
- timeFrame
- Time to Platelet recovery after nadir
Secondary outcomes (1)
- measure
- Determine whether E. coli or yeast rRNA fragments accelerate the recovery of platelets in patients undergoing chemotherapy.
- timeFrame
- Time to platelet transfusion 3 weeks after nadir
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * between the ages of 18 and 80 * currently receiving chemotherapy with a platelet nadir of less than or equal to 80,000 * Eastern Oncology Oncology Group (ECOG) performance status of 0, 1, 2, 3, and 4 * signed informed consent * willing to take RealBuild and magnesium supplement and undergoing chemotherapy known to induce thrombocytopenia * willing to stop benzodiazepines * must be at least 6 hours post therapeutic heparin dose Exclusion Criteria: * life expectancy less than three months * pregnant women or women of childbearing potential who refuse to use prophylaxis against pregnancy while receiving chemotherapy regimens * patients know hypersensitive to RNA or its metabolic products * patients requiring therapeutic heparin or benzodiazepines
References
Publications (1)
- DERIVEDLevin RD, Daehler M, Grutsch JF, Hall JL, Gupta D, Lis CG. Dose escalation study of an anti-thrombocytopenic agent in patients with chemotherapy induced thrombocytopenia. BMC Cancer. 2010 Oct 19;10:565. doi: 10.1186/1471-2407-10-565. PMID 20955619