Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016
Randomized phase II study of loratadine for the prevention of bone pain caused by pegfilgrastim.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01311336 (Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim), which is not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim
Who cites it
13 citing papers in PubMed, 34 citations in OpenAlex.
- Study of PEG-rhG-CSF for the prevention of neutropenia in concurrent chemoradiotherapy for nasopharyngeal carcinoma.PloS one · 2025Trial
- An open-label pilot study of recombinant granulocyte-colony stimulating factor in Friedreich's ataxia.Nature communications · 2022Trial
- NOLAN: a randomized, phase 2 study to estimate the effect of prophylactic naproxen or loratadine vs no prophylactic treatment on bone pain in patients with early-stage breast cancer receiving chemotherapy and pegfilgrastim.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Trial
- The use of antihistamine and antihistamine-like drugs for cancer-related pain: a narrative review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Review
- Taxane-Associated Acute Pain Syndrome: a Review of its Features and Management.Current treatment options in oncology · 2025Review
- Evaluation of the Effect of Loratadine versus Diosmin/Hesperidin Combination on Vinca Alkaloids-Induced Neuropathy: A Randomized Controlled Clinical Trial.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Repurposing of HNaunyn-Schmiedeberg's archives of pharmacology · 2024Article
- Higher incidence of pegfilgrastim-induced bone pain in younger patients receiving myelosuppressive chemotherapy: a real-world experience.Journal of pharmaceutical health care and sciences · 2023Article
- Risk factor analysis for taxane-associated acute pain syndrome under the dexamethasone prophylaxis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Article
- Comparative Analysis of Physicochemical Properties and Microbial Composition in High-TemperatureFrontiers in microbiology · 2020Article
- Pegfilgrastim-induced fatigue and leukocytosis improved following dose reduction in a young patient with breast cancer: A case report.Molecular and clinical oncology · 2019Article
- Clinical Safety and Efficacy of Secondary Prophylactic Pegylated G-CSF in Advanced Pancreatic Cancer Patients Treated with mFOLFIRINOX: A Single-center Retrospective Study.Internal medicine (Tokyo, Japan) · 2019Article
- Prevention of granulocyte-colony stimulating factor (G-CSF) induced bone pain using double histamine blockade.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 7 institutions in 1 country.
Funding
Abstract
purposeBone pain is a common side effect of pegfilgrastim and can interfere with quality of life and treatment adherence. This study investigated the impact of antihistamine prophylaxis on pegfilgrastim-induced bone pain.
methodsThis is a two-stage enrichment trial design. Patients receiving an initial dose of pegfilgrastim after chemotherapy were enrolled into the observation (OBS) stage. Those who developed significant back or leg bone pain (SP) were enrolled into the treatment (TRT) stage and randomized to daily loratadine 10 mg or placebo for 7 days. SP was defined by Brief Pain Inventory as back or leg pain score ≥5 and a 2-point increase after pegfilgrastim. The primary end point of TRT was reduction of worst back or leg bone pain with loratadine, defined as a 2-point decrease after treatment compared to OBS.
resultsTwo hundred thirteen patients were included in the final analysis. Incidence of SP was 30.5 %. The SP subset had a worse overall Functional Assessment of Cancer Therapy-Bone Pain score (33.9 vs. 51.7, p < 0.001) and a higher mean white blood cell count (15.4 vs. 8.4 K/cm(3), p = 0.013) following pegfilgrastim than those without SP. Forty-six patients were randomized in the TRT. Benefit was 77.3 % with loratadine and 62.5 % with placebo (p = 0.35). Baseline NSAID use was documented in four patients (18.2 %) in loratadine arm and two patients (8.3 %) in placebo arm, with baseline non-NSAID use documented in five (22.7 %) and six (25 %) patients, respectively. Eight additional patients used NSAIDS by day 8 compared to day 1 (six in the loratadine and two in the placebo arm). A total of six additional patients used non-NSAIDS by day 8 compared to day 1 (four in the loratadine and two in the placebo arm).
conclusionsAdministration of prophylactic loratadine does not decrease the incidence of severe bone pain or improve quality of life in a high-risk patient population. ClinicalTrials.gov identifier: NCT01311336.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.