Breast CancerPhase 2DETOXpNCT07109817
Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
A Phase 2 study testing Desloratodine in people with Breast Cancer and Peripheral Neuropathy, run by Montefiore Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Peripheral Neuropathy
- What is being tested?
- Desloratodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
- Patients must have an adequate organ and marrow function as defined below:
- absolute neutrophil count ≥1,000/microliter (mcL)
Show all 16Show fewer
- 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 efficacy assessment of the investigational regimen are eligible for this trial
- 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 subjects 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 medication dose. If male, must also agree to refrain from donating sperm during this period
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Jesus Anampa, MD, MS, 718-405-8505, janampa@montefiore.org
Rikin Ghandi, rikin.gandhi@einsteinmed.edu
About this study
Official title: Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer (DETOXp)
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.
Read the detailed description
Taxanes are frequently incorporated in first line chemotherapy regimens for breast cancer. Although taxane induces peripheral neuropathy (TIPN) is among the most common side effects of taxane treatment, currently there are no therapies that have consistently proven to be effective in preventing TIPN. TIPN involves a complex interplay of mechanisms which are not yet fully understood. However, neuroinflammation has been shown to be a critical component of the pathophysiology of TIPN. As a result, the discovery of novel therapies that can safely and efficiently attenuate the inflammatory drivers of TIPN and thus prevent the onset of bothersome and potentially disabling neuropathy, represents a unique opportunity to make a meaningful impact on the lives of breast cancer patients.
Desloratadine has shown promise for preventing TIPN in animal models, but based on available information has not yet been tested in humans. This study aims to build on this research by investigating the efficacy of desloratadine in preventing and ameliorating TIPN symptoms as assessed by validated neurotoxicity and quality of life questionnaires. Additionally, this study seeks to expand current knowledge about the role of inflammatory biomarkers as predictive markers of TIPN development. This study will investigate a broad subset of pro and anti-inflammatory cytokines, many of which have been previously shown to be mediated by the Histamine H1 Receptor (HRH1) and 5-HT 2A /c-Fos/NLRP3/IL-1β pathways. This study will measure histamine and nitric oxide levels, which have been show in-vivo to induce neuroinflammation and be upregulated in TIPN. This study will also assess nerve growth factor (NGF) and neurofilament light polypeptide (NF-L), which have protective, regenerative, nociceptive, and structural function in neurons. These biomarkers have shown to correlate with severity of TIPN, but thus far predictive utility is lacking and merits more research. Finally, this study aims to build upon current research regarding the human microbiome and its role in mediating inflammation and the onset of TIPN. Based on current knowledge, no prior study has investigated whether attenuation of chemotherapy induced inflammation via an antihistamine can prevent dysbiosis and help minimize the effect altered gut flora has on promoting further inflammation.
Desloratadine is a safe and inexpensive drug. This study is using 5mg PO dosing, every other day, because this is the standard dose used clinically for allergic rhinitis and chronic urticaria. Based on the effectiveness of loratadine in improving patient reported outcomes from vinca alkaloid induced neuropathy, and because of promising results of desloratadine in preventing and alleviating TIPN in mouse models, it is hypothesized that desloratadine will be an effective therapy to prevent TIPN in patients with breast cancer who receive adjuvant taxane-based chemotherapy regimens. Furthermore, it is also hypothesized that inflammatory biomarkers and gut microbiome signatures are associated with the development of TIPN. The effect of desloratadine in modulating such biomarkers will be monitored.
This double-blinded randomized controlled trial design will help mitigate bias in patient reported outcomes and clinician assessments. If the primary objective is met, desloratadine could potentially represent a safe, cost effective, and accessible strategy to prevent TIPN.
- Conditions
- Breast Cancer, Peripheral Neuropathy
- Being tested
- Desloratodine, Placebo
- Keywords
- Patient reported outcomes, Biomarkers, Taxane, Neuroinflammatory, Cytokine
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratodineDrug
Desloratadine 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.
PlaceboDrug
Placebo daily PO for 12 weeks. Placebo is a lactose filler covered by a capsule.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Paclitaxel or Docetaxel for 12 weeks and Placebo Receives: Drug: Placebo |
| Desloratodine | Experimental | Paclitaxel or Docetaxel for 12 weeks and Desloratadine Receives: Drug: Desloratodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to after completion of 12 weeks of taxane chemotherapy
Secondary outcomes (8)
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.
Measured: After completion of 12 weeks of taxane chemotherapy and at 24 weeks and 12 months after completing taxane chemotherapy
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.
Measured: After completion of 12 weeks of taxane chemotherapy
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.
Measured: From baseline to the completion of 12 weeks of taxane chemotherapy
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.
Measured: From baseline to the completion of 12 weeks of taxane chemotherapy
European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - Chemotherapy-induced Peripheral Neuropathy twenty-item scale (CIPN20) (EORTC QLQ CIPN20) survey score
The EORTC CIPN20 survey contains 20 items that address neuropathy symptoms using a 4-point Likert type scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"). based on 7-day recall. Given that the patient population in the study is expected to be predominately female and have significant heterogeneity in motor vehicle use, items 19 ("Did you have difficulty using the pedals?") and 20 ("Did you have difficulty getting or maintaining an erection?") will be omitted. The assessment thus can be divided into three subscales: sensory (9 items), motor (7 items), and autonomic symptoms (2 items). Each subscale is converted into a score ranging from 1-36, 1-28, and 1-8, respectively. All scales are linearly converted to a 0-100 total score where a higher score indicates worse symptoms.
Measured: 12 weeks after the completion of taxane chemotherapy
Rate of permanent discontinuation of taxane due to TIPN
The rate of permanent discontinuation of taxane will be calculated as the percentage of patients who discontinue taxane chemotherapy before 12 weeks due to TIPN. Results will be summarized by study arm.
Measured: From baseline up to week 12 of taxane chemotherapy
Rate of taxane dose interruption or dose reduction due to TIPN
The rate of taxane dose interruption or dose reduction will be calculated by the percentage of patients who experience taxane dose interruption or reduction due to TIPN before 12 weeks of taxane treatment. Results will be summarized by study arm.
Measured: From baseline up to week 12 of taxane chemotherapy
Rate of pathological complete response (pCR)
The rate of pathological complete response will be evaluated using the safety of adding desloratadine to taxane-based regimens on breast cancer outcomes. Pathological complete response(pCR), defined as no evidence of invasive carcinoma on breast or axilla after neoadjuvant chemotherapy (ypT0/Tis,ypN0), proposed as a surrogate of overall survival, will be summarized by study arm.
Measured: After completion of 12 weeks of taxane chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (83)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Permuted block randomization procedure will be used for which patients will be randomized between the two treatment arms and stratified using the following criteria specified: * Taxane drug: Paclitaxel vs. docetaxel * Platinum use: Yes vs. No
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesus R Anampa, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109817
- Sponsor's protocol ID
- 2025-16651
- Other IDs
- 2025
- Acronym
- DETOXp
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
PubMed 38230766Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
PubMed 9626712Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Electronic address: bc.overview@ctsu.ox.ac.uk; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials. Lancet. 2023 Apr 15;401(10384):1277-1292. doi: 10.1016/S0140-6736(23)00285-4.
PubMed 37061269Wani MC, Taylor HL, Wall ME, Coggon P, McPhail AT. Plant antitumor agents. VI. The isolation and structure of taxol, a novel antileukemic and antitumor agent from Taxus brevifolia. J Am Chem Soc. 1971 May 5;93(9):2325-7. doi: 10.1021/ja00738a045. No abstract available.
PubMed 5553076Schiff PB, Fant J, Horwitz SB. Promotion of microtubule assembly in vitro by taxol. Nature. 1979 Feb 22;277(5698):665-7. doi: 10.1038/277665a0. No abstract available.
PubMed 423966Horwitz SB. Personal recollections on the early development of taxol. J Nat Prod. 2004 Feb;67(2):136-8. doi: 10.1021/np0304464.
PubMed 14987047Zasadil LM, Andersen KA, Yeum D, Rocque GB, Wilke LG, Tevaarwerk AJ, Raines RT, Burkard ME, Weaver BA. Cytotoxicity of paclitaxel in breast cancer is due to chromosome missegregation on multipolar spindles. Sci Transl Med. 2014 Mar 26;6(229):229ra43. doi: 10.1126/scitranslmed.3007965.
PubMed 24670687Weaver BA. How Taxol/paclitaxel kills cancer cells. Mol Biol Cell. 2014 Sep 15;25(18):2677-81. doi: 10.1091/mbc.E14-04-0916.
PubMed 25213191Cortes JE, Pazdur R. Docetaxel. J Clin Oncol. 1995 Oct;13(10):2643-55. doi: 10.1200/JCO.1995.13.10.2643.
PubMed 7595719Gradishar WJ. Albumin-bound paclitaxel: a next-generation taxane. Expert Opin Pharmacother. 2006 Jun;7(8):1041-53. doi: 10.1517/14656566.7.8.1041.
PubMed 16722814Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.
PubMed 22152853Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med. 1995 Apr 13;332(15):1004-14. doi: 10.1056/NEJM199504133321507. No abstract available.
PubMed 7885406Ringel I, Horwitz SB. Studies with RP 56976 (taxotere): a semisynthetic analogue of taxol. J Natl Cancer Inst. 1991 Feb 20;83(4):288-91. doi: 10.1093/jnci/83.4.288.
PubMed 1671606Schneider BP, Shen F, Jiang G, O'Neill A, Radovich M, Li L, Gardner L, Lai D, Foroud T, Sparano JA, Sledge GW Jr, Miller KD. Impact of Genetic Ancestry on Outcomes in ECOG-ACRIN-E5103. JCO Precis Oncol. 2017;2017:PO.17.00059. doi: 10.1200/PO.17.00059. Epub 2017 Aug 21.
PubMed 29333527Michalova Z, Szekiova E, Blasko J, Vanicky I. Prevention and therapy of chemotherapy-induced peripheral neuropathy: a review of recent findings. Neoplasma. 2023 Feb;70(1):15-35. doi: 10.4149/neo_2022_221007N992. Epub 2022 Dec 28.
PubMed 36573482
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer (DETOXp)
- ClinicalTrials.gov ID
- NCT07109817
- Acronym / sponsor ID
- DETOXp / 2025-16651
- Conditions
- Breast Cancer, Peripheral Neuropathy
- Keywords
- Patient reported outcomes, Biomarkers, Taxane, Neuroinflammatory, Cytokine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Taxanes are frequently incorporated in first line chemotherapy regimens for breast cancer. Although taxane induces peripheral neuropathy (TIPN) is among the most common side effects of taxane treatment, currently there are no therapies that have consistently proven to be effective in preventing TIPN. TIPN involves a complex interplay of mechanisms which are not yet fully understood. However, neuroinflammation has been shown to be a critical component of the pathophysiology of TIPN. As a result, the discovery of novel therapies that can safely and efficiently attenuate the inflammatory drivers of TIPN and thus prevent the onset of bothersome and potentially disabling neuropathy, represents a unique opportunity to make a meaningful impact on the lives of breast cancer patients.
Desloratadine has shown promise for preventing TIPN in animal models, but based on available information has not yet been tested in humans. This study aims to build on this research by investigating the efficacy of desloratadine in preventing and ameliorating TIPN symptoms as assessed by validated neurotoxicity and quality of life questionnaires. Additionally, this study seeks to expand current knowledge about the role of inflammatory biomarkers as predictive markers of TIPN development. This study will investigate a broad subset of pro and anti-inflammatory cytokines, many of which have been previously shown to be mediated by the Histamine H1 Receptor (HRH1) and 5-HT 2A /c-Fos/NLRP3/IL-1β pathways. This study will measure histamine and nitric oxide levels, which have been show in-vivo to induce neuroinflammation and be upregulated in TIPN. This study will also assess nerve growth factor (NGF) and neurofilament light polypeptide (NF-L), which have protective, regenerative, nociceptive, and structural function in neurons. These biomarkers have shown to correlate with severity of TIPN, but thus far predictive utility is lacking and merits more research. Finally, this study aims to build upon current research regarding the human microbiome and its role in mediating inflammation and the onset of TIPN. Based on current knowledge, no prior study has investigated whether attenuation of chemotherapy induced inflammation via an antihistamine can prevent dysbiosis and help minimize the effect altered gut flora has on promoting further inflammation.
Desloratadine is a safe and inexpensive drug. This study is using 5mg PO dosing, every other day, because this is the standard dose used clinically for allergic rhinitis and chronic urticaria. Based on the effectiveness of loratadine in improving patient reported outcomes from vinca alkaloid induced neuropathy, and because of promising results of desloratadine in preventing and alleviating TIPN in mouse models, it is hypothesized that desloratadine will be an effective therapy to prevent TIPN in patients with breast cancer who receive adjuvant taxane-based chemotherapy regimens. Furthermore, it is also hypothesized that inflammatory biomarkers and gut microbiome signatures are associated with the development of TIPN. The effect of desloratadine in modulating such biomarkers will be monitored.
This double-blinded randomized controlled trial design will help mitigate bias in patient reported outcomes and clinician assessments. If the primary objective is met, desloratadine could potentially represent a safe, cost effective, and accessible strategy to prevent TIPN.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Permuted block randomization procedure will be used for which patients will be randomized between the two treatment arms and stratified using the following criteria specified: * Taxane drug: Paclitaxel vs. docetaxel * Platinum use: Yes vs. No
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPaclitaxel or Docetaxel for 12 weeks and Placebo |
| Desloratodine | Experimental | Drug: DesloratodinePaclitaxel or Docetaxel for 12 weeks and Desloratadine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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%)
- Patients must have an adequate organ and marrow function as defined below:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesloratodineDesloratadine 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. | Drug | Desloratodine |
| PlaceboPlacebo daily PO for 12 weeks. Placebo is a lactose filler covered by a capsule. | Drug | Placebo |
Primary outcome
Change in Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) Subscale Version 4 (FACT-GOG-NTX) neuropathy score
Time frame: From baseline to after completion of 12 weeks of taxane chemotherapy
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.
8 secondary outcomes
Rate of grade 2-4 TIPN assessed by treating physician
Time frame: After completion of 12 weeks of taxane chemotherapy and at 24 weeks and 12 months after completing taxane chemotherapy
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey score
Time frame: After completion of 12 weeks of taxane chemotherapy
Change in Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT-GOG-NTX) quality of life survey score
Time frame: From baseline to the completion of 12 weeks of taxane chemotherapy
Change in Patient-Reported Outcomes Measurement Information Systems (PROMIS) 29 v2.1 survey score
Time frame: From baseline to the completion of 12 weeks of taxane chemotherapy
European Organisation of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - Chemotherapy-induced Peripheral Neuropathy twenty-item scale (CIPN20) (EORTC QLQ CIPN20) survey score
Time frame: 12 weeks after the completion of taxane chemotherapy
Rate of permanent discontinuation of taxane due to TIPN
Time frame: From baseline up to week 12 of taxane chemotherapy
Rate of taxane dose interruption or dose reduction due to TIPN
Time frame: From baseline up to week 12 of taxane chemotherapy
Rate of pathological complete response (pCR)
Time frame: After completion of 12 weeks of taxane chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 38230766Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024 Jan-Feb;74(1):12-49. doi: 10.3322/caac.21820. Epub 2024 Jan 17.
- Background: PubMed 9626712Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
- Background: PubMed 37061269Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Electronic address: bc.overview@ctsu.ox.ac.uk; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials. Lancet. 2023 Apr 15;401(10384):1277-1292. doi: 10.1016/S0140-6736(23)00285-4.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jesus R Anampa, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desloratodine in people with Breast Cancer and Peripheral Neuropathy, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesus R Anampa, MD, MS (7184058505, janampa@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) Subscale Version 4 (FACT-GOG-NTX) neuropathy score (time frame: From baseline to after completion of 12 weeks of taxane chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07109817, which also lists 83 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.