Clinical trial · Interventional
Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter
A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Fragmin (5,000 IU Subcutaneously) in Preventing Catheter-Related Complications When Given Daily to Cancer Patients With Central Venous Catheters
- 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)
RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fragmin | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fragmin
- description
- Fragmin at 5000 IU injected subcutaneously daily
- interventionNames
- Drug: Fragmin
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- placebo injected subcutaneously daily
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- To determine if 5000 IU of Fragmin administered daily when compared to placebo will reduce the incidence of clinically relevant CRCs in cancer patients receiving chemotherapy by CVC
- timeFrame
- 16 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignancy * No more than 5 days since placement of central venous catheter for administration of chemotherapy * Expected length of catheter use at least 16 weeks * 18 and over * Performance status: ECOG 0-2 * Life expectancy: At least 16 weeks * Hematopoietic: * Platelet count at least 100,000/mm3 * Absolute neutrophil count at least 1,500/mm3 * No known coagulopathy * Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) except in case of Gilbert's syndrome * AST no greater than 3 times ULN (no greater than 5 times ULN in case of liver metastases) * PT/PTT no greater than 1.5 times ULN Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * HIV negative * Must weigh at least 90 pounds * At least 3 months since prior eye, ear, or CNS surgery Other: * At least 30 days since prior aspirin, dipyridamole, unfractionated heparin, other low molecular weight heparins, or other anticoagulation therapy (except heparin flushing) Exclusion Criteria: * uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure * myocardial infarction in past 6 months * uncontrolled cardiac arrhythmia Other: * known hypersensitivity (including heparin induced thrombocytopenia) to dalteparin, heparin, or other low molecular weight heparins * active uncontrolled infection, including existing catheter related infection * CNS trauma in past 3 months * retinal detachment in past 6 months * mental incapacitation or psychiatric illness that would preclude study compliance * other serious concurrent disease that would preclude study participation * active gastrointestinal or genitourinary tract bleeding * intracranial or intraocular hemorrhage in past year * concurrent high dose chemotherapy with stem cell transplantation * concurrent induction/consolidation chemotherapy for leukemia * concurrent high dose chemotherapy with stem cell transplantation
References
Publications (0)
Data not yet available