Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 (including platinums) are eligible. Patients planned to receive taxanes plus single or dual antiher2 therapy are also eligible. Patients planned to receive taxane-based regimen with immune checkpoint inhibitors are also allowed
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Desloratodine
DrugDesloratadine 5mg PO every other day for 12 weeks. Desloratadine is a long- acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine inhibited histamine release from human mast cells.
Placebo
DrugPlacebo daily PO for 12 weeks. Placebo is a lactose filler covered by a capsule.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: DesloratodineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) Subscale Version 4 (FACT-GOG-NTX) neuropathy score
The patient-related-outcome based neurotoxicity will be assessed using the 11 items about neurotoxicity in the FACT/GOG-NTX questionnaire. For the FACT/GOG-NTX neuropathy, each item is scored from 0-4, and the neurotoxicity total score is the sum of the scores for the 11 items, and ranges from 0 to 44. Lower values of the FACT/GOG-NTX neurotoxicity total score indicate higher neurotoxicity. The FACT/GOG-NTX neurotoxicity total score will be analyzed as a continuous variable. Proper transformation to improve normality will be used if needed. Change in FACT/GOG-NTX neuropathy score will be defined as the difference in score values between baseline versus after 12 weeks of taxane chemotherapy.
Time frame
From baseline to after completion of 12 weeks of taxane chemotherapySecondary outcomes
1
Rate of grade 2-4 TIPN assessed by treating physician
The rate of grade 2-4 TIPN will be assessed by treating physician using CTCAE V5.0 while on taxane treatment. Patients will be coded as having the event if grade 2-4 neuropathy occurred at any time during the observation period. Patients without neuropathy or with maximum of grade 1 neuropathy will be coded as having no event. Of note, only neuropathy with a treatment relationship classified as possibly, probably, or definitely will be considered as taxane-induced neuropathy, whereas neuropathy with a treatment relationship classified as unrelated or unlikely will not be considered an event in the study design.
Time frame
After completion of 12 weeks of taxane chemotherapy and at 24 weeks and 12 months after completing taxane chemotherapy2
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey score
The PRO-CTCAE includes a two-item questionnaire that focuses on taxane-induced peripheral neuropathy (TIPN) in which each item is scored 0 to 4 and a three-item questionnaire that focuses on general pain in which each item is scored 0 to 4. Scores from the two questionnaires are composited yielding an overall possible scoring range of 0-20, such that higher scores represent a patient's self-reported experience of the frequency, severity, and impact of neuropathy and pain on daily activities.
Time frame
After completion of 12 weeks of taxane chemotherapy3
Change in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) quality of life survey score
The FACT/GOG-NTX quality of life survey score contains 27 questions evaluating 4 domains of quality of life. Each question is scored 0 to 4. The physical wellbeing domain has 7 questions, and the total score ranges from 0-28. The social family well-being domain has 7 questions, and the total score ranges from 0-28. The emotional well-being domain has 6 questions, and the total score ranges from 0-24. The functional well-being score has 7 questions, and the total score ranges from 0-28. The total score for each domain will be summarized and reported as a continuous variable. Researchers will define change in each domain score as the difference in score values between baseline vs. after 12 weeks of taxane chemotherapy.
Time frame
From baseline to the completion of 12 weeks of taxane chemotherapy4
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 29 v2.1 survey score
The PROMIS 29 survey contains items from seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). The PROMIS-29 assesses 7 domains with 4 questions each. There is an additional question that assesses pain intensity 0-10 on numeric rating scale. Tables in the protocol will be used to translate the total raw score into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean.
Time frame
From baseline to the completion of 12 weeks of taxane chemotherapySponsors and contacts
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Source ClinicalTrials.gov