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New treatment option for Breast Cancer
Official title Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
ClinicalTrials.gov ID: NCT07109817
What this study is testing
What is Desloratodine?
Desloratodine is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a double-blinded randomized controlled clinical trial that aims to study if desloratadine can reduce rates of peripheral neuropathy development in patients with breast cancer receiving taxane chemotherapy. Researchers will compare desloratadine to a placebo (look-alike substance with no drug) and use validated neurotoxicity and quality of life questionnaires to determine if desloratadine can be used to prevent or make taxane induced peripheral neuropathy (TPIN) symptoms better.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically confirmed breast cancer, stage I-III as per the American Joint Committee on Cancer (AJCC) 8th edition (Anatomic...
- Patients must be planned to receive taxane-based regimen for breast cancer (Adjuvant or neoadjuvant) of at least 12 weeks duration. Patients planned...
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)
- Patients must have an adequate organ and marrow function as defined below:
You likely can't join if
- Patients with prior diagnosis of peripheral neuropathy
- Patients who received chemotherapy for the current breast cancer diagnosis before the planned taxane-based regimen
- Patients who are receiving any other investigation agents
- Patients with concurrent use of antihistamines during or for 2 days prior to the study period
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to desloratadine
- Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably...
See the full eligibility criteria
- Patients must have histologically confirmed breast cancer, stage I-III as per the American Joint Committee on Cancer (AJCC) 8th edition (Anatomic Staging)
- Patients must be planned to receive taxane-based regimen for breast cancer (Adjuvant or neoadjuvant) of at least 12 weeks duration. Patients planned to receive taxanes in combination with other chemotherapy drugs...
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)
- Patients must have an adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/microliter (mcL)
- platelets ≥100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
- Creatinine ≤ institutional ULN
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients with prior diagnosis of diabetes mellitus are allowed if the patient has no peripheral neuropathy
- Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
- Patients must not have received prior taxane or platinum therapy
- Women of childbearing potential must have a negative pregnancy test: serum or urine beta human chorionic gonadotropin (hCG) within 14 days prior to first dose of study treatment
- Potential fertile people must agree to use adequate contraception (double barrier methods of birth control or abstinence) prior to start of treatment, for the duration of treatment, and 28 days after last study...
- Patients with prior diagnosis of peripheral neuropathy
- Patients who received chemotherapy for the current breast cancer diagnosis before the planned taxane-based regimen
- Patients who are receiving any other investigation agents
- Patients with concurrent use of antihistamines during or for 2 days prior to the study period
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to desloratadine
- Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
- Pregnant or breastfeeding women are not allowed in the study
- Patients who are taking probiotics
- Patients who are using chronic laxatives or enema
- Patients who used antibiotics within 4 weeks of registration
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.