Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin
NCT04541355 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2024-06-28
Summary
This phase II trial investigates how well sodium thiosulfate works in preventing ototoxicity (hearing loss/damage) in patients with squamous cell cancer of the head and neck that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing a chemoradiation. Sodium thiosulfate is a type of medication used to treat cyanide poisoning and to help lessen the side effects from cisplatin. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. The purpose of this trial is to find out whether it is feasible to give sodium thiosulfate 4 hours after each cisplatin infusion along with standard of care radiation therapy in patients with head and neck cancer. Giving sodium thiosulfate after cisplatin may help decrease the risk of hearing loss.
Conditions
- Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
- Locally Advanced Laryngeal Squamous Cell Carcinoma
- Locally Advanced Oral Cavity Squamous Cell Carcinoma
- Locally Advanced Oropharyngeal Squamous Cell Carcinoma
- Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IV Hypopharyngeal Carcinoma AJCC v8
- Stage IV Laryngeal Cancer AJCC v8
- Stage IV Lip and Oral Cavity Cancer AJCC v8
- Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Lip and Oral Cavity Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVC Hypopharyngeal Carcinoma AJCC v8
- Stage IVC Laryngeal Cancer AJCC v8
- Stage IVC Lip and Oral Cavity Cancer AJCC v8
- Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Interventions
- DRUG
-
Given IV
- OTHER
-
Hearing Handicap Inventory for Adults - Screening
Patient self-assessment questionnaire to measure probability of hearing impairment
- RADIATION
-
Radiation Therapy
Radiation therapy will be delivered according to the standard of care
- DRUG
-
Sodium Thiosulfate
Given IV
Sponsors & Collaborators
-
NRG Oncology
collaborator OTHER -
Hyunseok Kang, MD
lead OTHER
Principal Investigators
-
Hyunseok Kang, MD · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-14
- Primary Completion
- 2023-05-31
- Completion
- 2023-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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