- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06207487
Clinical and Economic Impact of Herpes Zoster in Cancer Patients
Clinical and Economic Impact of Herpes Zoster in Cancer Patients - A Retrospective Cohort Study in a Brazilian Cancer Center
Study Overview
Detailed Description
Herpes zoster (HZ) is associated with substantial morbidity among patients with cancer because of disease-related and treatment-related immunosuppression. Beyond the acute infection, HZ may delay anticancer treatment, increase healthcare utilization, and lead to long-term complications such as postherpetic neuralgia. Despite its clinical relevance, real-world data describing the clinical burden and direct hospital costs of HZ in oncology patients in Brazil remain limited.
This retrospective observational cohort study included adult patients with active cancer diagnosed with herpes zoster between September 2019 and December 2024 at A.C. Camargo Cancer Center, São Paulo, Brazil. Patients were identified through electronic medical records and institutional infection control databases. Demographic characteristics, cancer type and stage, recent oncologic therapies, clinical presentation, complications, recurrence, and postherpetic neuralgia were evaluated. Direct hospital costs related to emergency department visits and hospitalizations were obtained from institutional administrative databases.
The study was designed to characterize the clinical and economic burden of herpes zoster in oncology patients and to explore associations between oncologic characteristics and clinical and economic outcomes, providing real-world evidence to support future health economic evaluations and vaccination strategies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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São Paulo
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São Paulo, São Paulo, Brazil, 01509-001
- A.C.Camargo Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (≥18 years).
- Active solid or hematologic malignancy.
- Evaluation at A.C. Camargo Cancer Center (São Paulo, Brazil) between September 2019 and December 2024.
- Clinically confirmed episode of herpes zoster (initial episode or recurrence).
- Herpes zoster diagnosed based on a typical painful dermatomal rash with polymorphic lesions (macules, papules, vesicles, and crusts), either localized or disseminated.
Exclusion Criteria:
- Age <18 years.
- No evidence of active malignancy (complete remission or no oncologic treatment for at least one year).
- Patients in whom herpes zoster was not confirmed after medical record review.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Patients with Herpes Zoster and Active Cancer
Adult patients with active solid or hematologic malignancies who presented with a clinically confirmed episode of herpes zoster between September 2019 and December 2024 at A.C. Camargo Cancer Center, São Paulo, Brazil.
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Clinically confirmed herpes zoster episode (initial episode or recurrence) identified through electronic medical records.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical characteristics of herpes zoster episodes
Time Frame: September 2019 through December 2024
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Characterization of herpes zoster episodes in adult patients with active cancer, including clinical presentation, dissemination, postherpetic neuralgia, recurrence, cancer type and stage, and recent oncologic therapies.
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September 2019 through December 2024
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Direct hospital costs
Time Frame: September 2019 through December 2024
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Estimation of direct hospital costs associated with emergency department visits and hospitalizations related to herpes zoster in patients with active cancer.
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September 2019 through December 2024
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postherpetic neuralgia
Time Frame: 3 months after herpes zoster episode
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Occurrence of postherpetic neuralgia, defined as neuropathic pain persisting for at least 3 months after the onset of herpes zoster.
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3 months after herpes zoster episode
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Varicella Zoster Virus Infection
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Diseases
- Infections
- Virus Diseases
- Peripheral Nervous System Diseases
- DNA Virus Infections
- Herpesviridae Infections
- Neuralgia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neoplasms
- Herpes Zoster
- Neuralgia, Postherpetic
Other Study ID Numbers
- 3527/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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