RECRUITING

Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia.

Official Title

Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia

Quick Facts

Study Start:2024-11-23
Study Completion:2027-03-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06283745

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients \>= 18 years of age
  2. * Patients who have qualitative olfactory distortion
  3. * Etiology of qualitative olfactory distortion is due to upper respiratory infection
  4. * Quantitative score under the 10th percentile on the SSParoT (HedRang and HedDir)
  5. * Quantitative score ≥ 8 on the QOD.
  6. * At least 6 months of parosmia but less than 24 months
  7. * Patients can have been previously treated with oral and topical steroids but this is not a requirement
  8. * Patients will receive concurrent olfactory training - the practice of smelling strong odors (standard of care)
  9. * Be able to read and understand English
  10. * Be able and willing to provide Informed Consent
  1. * Patients \< 18 years of age, pregnant females, patients who have structural abnormalities on nasal endoscopy or radiographic imaging that would prevent injection into the olfactory cleft
  2. * Olfactory loss due to trauma, chronic sinusitis / inflammation / polyps, neoplasms, or neurodegenerative diseases or patients who have had olfactory loss \> 24 months
  3. * Patients with bleeding disorders or on blood thinners such as coumadin and plavix

Contacts and Locations

Study Contact

Homer Abaya, BS
CONTACT
(650) 725-6500
habaya@stanford.edu
Maxime Fieux, MD, PhD
CONTACT
+33621611643
fieuxma@stanford.edu

Principal Investigator

Zara Patel, MD
PRINCIPAL_INVESTIGATOR
Stanford Otolaryngology - Head and Neck Surgery

Study Locations (Sites)

Stanford Sinus Center / Stanford University School of Medicine
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Zara Patel, MD, PRINCIPAL_INVESTIGATOR, Stanford Otolaryngology - Head and Neck Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-23
Study Completion Date2027-03-22

Study Record Updates

Study Start Date2024-11-23
Study Completion Date2027-03-22

Terms related to this study

Additional Relevant MeSH Terms

  • Paraosmia