Desloratadine for Nerve Damage in Breast Cancer
(DETOXp Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether desloratadine, a common allergy medication, can prevent or reduce nerve damage from taxane chemotherapy in breast cancer patients. Participants will receive either desloratadine or a placebo alongside their chemotherapy to determine its effect on peripheral neuropathy symptoms. This trial suits those with stage I-III breast cancer scheduled for 12 weeks of taxane-based chemotherapy who have not previously received taxane or platinum treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
The trial requires that you stop using antihistamines during or for 2 days before the study period. You also cannot take probiotics, chronic laxatives, or enema, and must not have used antibiotics within 4 weeks of joining the trial.
Is there any evidence suggesting that desloratadine is likely to be safe for humans?
Research has shown that desloratadine is generally safe for use. The FDA has already approved it for treating allergies. In studies involving people, desloratadine did not cause serious side effects, suggesting it might be safe for other uses, such as treating nerve damage. This information is important for those considering participation in a trial for nerve damage caused by chemotherapy. Although this trial is in an early stage, the existing approval and research indicate a good safety profile.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for nerve damage in breast cancer, which often involve pain management and nerve protection strategies, Desloratadine is unique because it uses an antihistamine approach. Most treatments focus on managing symptoms after nerve damage has occurred, but Desloratadine targets inflammation at the nerve level, potentially preventing damage from developing in the first place. Researchers are excited because this could offer a new way to protect nerves during chemotherapy with drugs like Paclitaxel or Docetaxel, potentially reducing side effects and improving quality of life for patients.
What evidence suggests that desloratadine might be an effective treatment for peripheral neuropathy in breast cancer patients?
Research has shown that desloratadine, which participants in this trial may receive, might help reduce nerve damage caused by taxane chemotherapy in breast cancer patients. Studies found that desloratadine decreases certain proteins that lead to nerve damage. This suggests it could alleviate symptoms of peripheral neuropathy, such as pain, tingling, or numbness in the hands and feet. Although research continues, these findings offer hope that desloratadine could ease chemotherapy side effects.12345
Who Is on the Research Team?
Jesus R Anampa, MD, MS
Principal Investigator
Montefiore Medical Center
Are You a Good Fit for This Trial?
This trial is for breast cancer patients undergoing taxane chemotherapy who may be at risk of developing peripheral neuropathy, a type of nerve damage. Participants should not have pre-existing conditions that could interfere with the study or be taking other medications that affect neurotoxicity.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Paclitaxel or Docetaxel for 12 weeks along with either Desloratadine or a placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of neuropathy and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Desloratadine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Montefiore Medical Center
Lead Sponsor