Clinical Trials Logo
  1. Home
  2. Head and Neck Carcinoma
  3. NCT04151082

High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors

Head and Neck Carcinoma Clinical Trial

Official title:
Stop LCNP: High Dose Steroid Therapy for Late Radiation-Associated Lower Cranial Neuropathy: A Phase I/II Dose Finding Trial and Data Registry

Clinical Trial Summary

This phase I/II trial studies the side effect and best dose of steroid therapy (prednisone or methylprednisolone) in improving symptoms of late radiation-associated lower cranial neuropathy in oropharyngeal cancer survivors. Steroid therapy with prednisone or methylprednisolone may help to improve symptoms associated with late radiation-associated lower cranial neuropathy.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To establish feasibility and maximum tolerated dose (MTD) of steroid therapy that provides symptomatic improvement in oropharyngeal cancer (OPC) survivors with late lower cranial neuropathy (LCNP). SECONDARY OBJECTIVE: I. To examine endpoints that may be sensitive to functional or symptomatic gains with steroid therapy for late LCNP in OPC survivors by characterizing changes in symptoms, functional status, quality of life (QOL), neurophysiology, and imaging studies after steroid therapy. TERTIARY OBJECTIVE: I. To establish a hypothesis-generating database of physiologic, functional, and patient-reported outcomes (PROs) among head and neck cancer (HNC) survivors with late lower cranial neuropathy treated with steroid therapy. OUTLINE: This is a phase I, dose-escalation study of steroid therapy followed by a phase II study. Patients receive prednisone orally (PO) (or by feeding tube) once daily (QD) on days 1-5 and then taper off over 2 weeks or methylprednisolone intravenously (IV) over 1 hour on days 1-5 in the absence of disease progression or unacceptable toxicity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04151082
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Katherine A Hutcheson
Phone 713-792-6513
Email karnold@mdanderson.org
Status Recruiting
Phase Phase 1/Phase 2
Start date October 31, 2019
Completion date July 31, 2024
View Details
See also
  Status Clinical Trial Phase
Terminated NCT04110249 - Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer N/A
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Completed NCT03663985 - FALCOn (Facteur AnthropoLogique Cancer Orl)
Recruiting NCT05544136 - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer Phase 2
Recruiting NCT05077072 - Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients Phase 2
Completed NCT03964896 - Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy N/A
Recruiting NCT04147494 - Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues Early Phase 1
Completed NCT02474095 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer N/A
Withdrawn NCT03261180 - Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer N/A
Terminated NCT04618432 - Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
Active, not recruiting NCT02615275 - Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy N/A
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Recruiting NCT00991094 - Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Recruiting NCT04870762 - Customized 3D Printed Oral Stents During Head and Neck Radiotherapy Phase 2
Completed NCT02369835 - Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy Phase 3
Completed NCT03902535 - Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers
Recruiting NCT05526924 - Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer Phase 1
Recruiting NCT03795610 - Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT04788264 - Exercise Training and Behavioral Modification for the Improvement of Physical Activity in Head and Neck Cancer Patients Undergoing Cancer Treatment N/A
Recruiting NCT05669430 - A Study of GV20-0251 in Patients With Solid Tumor Malignancies Phase 1