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Sodium Thiosulfate for Chemotherapy-Induced Hearing Loss

Q: What are the criteria for enlistment in this clinical experimentation?

To partake in this clinical trial, prospective patients must have ototoxicity from a drug-based cause and be between 1 month and 39 years old. Currently, 33 people are being recruited for the study.

Q: Are there any remaining vacancies for those interested in participating within this trial?

Affirmative. According to clinicaltrials.gov, this <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> research is currently searching for volunteers; it was first published on March 1st 2023 and most recently updated on the 2nd of that same month. The team seeks 33 participants from a single facility.

Q: How extensive is the participant pool of this research experiment?

Affirmative. The clinicaltrials.gov website exhibits that this trial, which was initially listed on March 1st 2023, is actively recruiting participants. 33 individuals are needed to participate from a single medical site.

Q: Is the age requirement for this trial flexible enough to accept participants aged 70 and over?

The requirements to become a participant in this research include being between 1 Month and 39 years old. 32 trials are available for minors, while 15 focus on elderly individuals.

Phase < 1

Recruiting

Led By James Geller, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion up to 5 years

Awards & highlights

Study Summary

This trial will test a drug (Sodium Thiosulfate) to see if it can prevent hearing loss from chemotherapy. #medicaltrial

Who is the study for?

This trial is for patients aged 1 month to 39 years with hepatoblastoma or certain other cancers, who have previously responded to cisplatin but now show progression or resistance. They must have a life expectancy of at least 8 weeks, good organ function, and no severe side effects from previous treatments. Pregnant women and those with heart failure or uncontrolled illnesses are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness of Sodium Thiosulfate (STS) in preventing hearing loss when given alongside cisplatin-based chemotherapy. There are two regimens: CS (Cisplatin/STS) for those previously sensitive to cisplatin, and CSS (Cisplatin/STS/Vorinostat) for those who've shown progression on or resistance to cisplatin.See study design

What are the potential side effects?

Potential side effects include allergic reactions to treatment components, issues related to bone marrow suppression like low blood counts, liver problems indicated by abnormal bilirubin and enzyme levels, kidney dysfunction measured by creatinine clearance rates, and possibly worsening of pre-existing hearing loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevention of hearing loss

Secondary outcome measures

Maximum Plasma Concentration [Cmax]

Number of Participants with Treatment-Related Adverse Events

Prevention of hearing loss and tumor reduction

+2 more

Side effects data

From 2023 Phase 2 & 3 trial • 15 Patients • NCT03267277

100%

Flow cytometry

100%

Systolic hypertension

100%

Venous oxygen saturation decreased

100%

Hypertension

100%

Venous oxygen saturation increased

93%

Hypokalemia

93%

Blood chloride increased

93%

Red blood cell count decreased

93%

Hyperglycemia

93%

Urine sodium increased

93%

Blood lactate dehydrogenase increased

93%

Anemia

93%

Immature granulocyte percentage increased

93%

Hyponatremia

93%

Diastolic hypotension

93%

Creatinine urine decreased

93%

Urine protein, quantitative increased

86%

Red cell distribution width increased

86%

Coagulation factor VIII level increased

86%

Urine magnesium decreased

86%

Urine protein/creatinine ratio increased

86%

White blood cells urine increased

86%

Urine analysis abnormal

79%

Blood bicarbonate decreased

79%

PO2 increased

79%

PCO2 decreased

79%

Blood bicarbonate increased

79%

Carbon dioxide decreased

79%

Mean cell hemoglobin concentration decreased

71%

Urine phosphorus decreased

71%

Creatinine renal clearance decreased

71%

Blood immunoglobulin G increased

71%

Urine ketone body present

71%

Venous blood pH decreased

71%

Immature granulocyte count increased

71%

Red blood cells urine increased

71%

Blood albumin decreased

71%

Vitamin D decreased

71%

Hypocalcemia

64%

Calcium ionized decreased

64%

C-reactive protein-high sensitivity increased

64%

Blood creatinine decreased

64%

Ionized Magnesium increased

64%

Sinus tachycardia

64%

Lymphocyte percentage increased

64%

Hypoglycemia

64%

Reticulocyte percentage increased

64%

Ionized Magnesium decreased

64%

Creatinine urine increased

57%

Urine leukocyte esterase positive

57%

Reticulocyte hemoglobin equivalent

57%

Eosinophil count decreased

57%

Cystatin C increased

57%

Red blood cell sedimentation rate increased

50%

Basophil percentage increased

50%

Transferrin saturation decreased

50%

Blood phosphorus decreased

50%

Serum ferritin increased

50%

Urine potassium decreased

50%

Nausea

50%

Erythroblast count increased

50%

Glucose urine present

50%

Blood urea nitrogen decreased

50%

Neutrophil percentage decreased

50%

Absolute neutrophil count increased

50%

Urine magnesium increased

43%

Antinuclear antibody increased

43%

Blood creatine phosphokinase increased

43%

Fibroblast growth factor 23 increased

43%

Basophil count increased

43%

Protein total increased

43%

Monocyte percentage decreased

43%

Activated partial thromboplastin time shortened

43%

Eosinophil percentage decreased

43%

Blood phosphorus increased

43%

Reticulocyte count increased

43%

Blood parathyroid hormone increased

43%

Urine oxalate decreased

43%

Hypomagnesemia

43%

Lymphocyte percentage decreased

43%

Von Willebrand's factor activity increased

43%

Urine phosphorus increased

43%

Hypotension

43%

Alanine aminotransferase increased

43%

Blood iron decreased

43%

Hemoglobin urine present

43%

Neutrophil percentage increased

43%

Blood immunoglobulin E increased

43%

Mean platelet volume decreased

43%

White blood cell count increased

36%

Headache

36%

Blood insulin increased

36%

Anion gap decreased

36%

Brain natriuretic peptide increased

36%

Diastolic hypertension

36%

Blood immunoglobulin A increased

36%

Aspartate aminotransferase increased

36%

Citric acid urine decreased

36%

Protein urine present

36%

Blood erythropoietin increased

36%

Platelet count decreased

36%

Absolute lymphocyte count increased

36%

Urine calcium decreased

36%

Blood thyroid stimulating hormone increased

36%

Anion gap increased

29%

Blood creatine phosphokinase MB increased

29%

Urinary casts present

29%

Calcium ionized increased

29%

Blood alkaline phosphatase decreased

29%

Absolute neutrophil count decreased

29%

Abnormal clotting factor

29%

Von Willebrand's factor antigen increased

29%

Blood chloride decreased

29%

Pain in extremity

29%

Absolute monocyte count decreased

29%

Protein total decreased

29%

Aldolase increased

29%

Sinus bradycardia

29%

Urine uric acid increased

29%

Absolute monocyte count increased

29%

Blood uric acid increased

29%

Eosinophil percentage increased

29%

Myelocyte percentage increased

29%

White blood cell count decreased

21%

Blood triglycerides increased

21%

PO2 decreased

21%

Creatinine renal clearance increased

21%

Activated partial thromboplastin time prolonged

21%

Monocyte percentage increased

21%

Basophil count decreased

21%

Blood immunoglobulin M decreased

21%

Urine calcium increased

21%

Basophil percentage decreased

21%

Antinuclear antibody positive

21%

Glycosylated hemoglobin increased

21%

Hepatitis B surface antigen positive

21%

Hepatitis B core antibody positive

21%

Human T-cell lymphotropic virus infection

21%

Hypernatremia

21%

Corona virus infection

14%

Hyperthermia

14%

Anisocytosis

14%

Blood magnesium increased

14%

Mean cell hemoglobin decreased

14%

Thyroxine free decreased

14%

Dental caries

14%

Catheter site infection

14%

Red blood cell morphology abnormal

14%

Specific gravity urine increased

14%

Vitamin B12 increased

14%

Insulin C-peptide increased

14%

Urine sodium decreased

14%

Vitamin D increased

14%

Transferrin decreased

14%

Nitrite urine present

14%

Metamyelocyte percentage increased

14%

Urine calcium oxalate

14%

Autoantibody positive

14%

Absolute lymphocyte count decreased

14%

Urobilinogen urine

14%

Urine albumin/creatinine ratio increased

14%

Urine uric acid decreased

14%

Blood thyroid stimulating hormone decreased

14%

Blood folate increased

14%

Hypercalcemia

14%

Platelet count increased

14%

Blood cholesterol increased

14%

Prothrombin time prolonged

Urine oxalate increased

Hyperuricemia

Blood calcium decreased

Blood creatinine increased

Venous blood pH increased

PCO2 increased

Hemoglobin decreased

Platelet morphology abnormal

Anxiety

Blister

Lipids abnormal

T-lymphocyte count increased

Hepatitis viral

Wound infection staphylococcal

Haptoglobin decreased

Reticulocyte count decreased

Urine amino acid level abnormal

Mean cell volume increased

Pruritus

Aspartate aminotransferase

Blood parathyroid hormone decreased

Promyelocyte count increased

Lymphocyte count decreased

Bilirubin urine present

Bilirubin conjugated

Blood bilirubin increased

Low density lipoprotein abnormal

Procedural dizziness

Foreign body

Blood homocysteine increased

Red blood cell poikilocytes present

Thyroxine decreased

Carbon dioxide increased

Blood immunoglobulin D increased

Transferrin saturation increased

Cystatin C abnormal

Alanine aminotransferase

Drug level above therapeutic

Blood creatine phosphokinase decreased

Prothrombin time shortened

Nasal congestion

Red blood cell sedimentation rate

Laboratory test

Aspartate aminotransferase decreased

Serum ferritin decreased

Eosinophil count increased

Fibrin D dimer increased

Blood parathyroid hormone

Red blood cell microcytes present

Migraine

Electrophoresis protein abnormal

Neutrophil count decreased

Albumin urine present

Haptoglobin increased

Citric acid urine increased

Blood bilirubin decreased

Blood iron increased

Hyperkalemia

Urine potassium increased

Mean cell volume decreased

Urea renal clearance decreased

Beta 2 microglobulin urine increased

Device related infection

Blood glucose increased

Mean cell hemoglobin increased

Blood urea nitrogen increased

Transferrin increased

Nephrolithiasis

Anion gap

Vomiting

pH urine increased

Epstein-Barr virus infection

100%

80%

60%

40%

20%

Study treatment Arm

Treatment

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum 2B- Regimen CSSExperimental Treatment1 Intervention

Wilms tumor, GCT, Neuroblastoma

Group II: Stratum 2A- Regimen CSSExperimental Treatment1 Intervention

Cisplatin resistant or progressed on cisplatin after initial response (when given at first diagnosis)

Group III: Stratum 1- Regimen CSExperimental Treatment1 Intervention

Cisplatin sensitive/no progression on cisplatin (when given at first diagnosis)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sodium Thiosulfate

2014

Completed Phase 3

~90

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,530,924 Total Patients Enrolled

James Geller, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

5 Previous Clinical Trials

1,087 Total Patients Enrolled

Media Library

Stratum 2B- Regimen CSS Clinical Trial Eligibility Overview. Trial Name: NCT05756660 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for enlistment in this clinical experimentation?

"To partake in this clinical trial, prospective patients must have ototoxicity from a drug-based cause and be between 1 month and 39 years old. Currently, 33 people are being recruited for the study."

Answered by AI

Are there any remaining vacancies for those interested in participating within this trial?

"Affirmative. According to clinicaltrials.gov, this experimental research is currently searching for volunteers; it was first published on March 1st 2023 and most recently updated on the 2nd of that same month. The team seeks 33 participants from a single facility."

Answered by AI

How extensive is the participant pool of this research experiment?

"Affirmative. The clinicaltrials.gov website exhibits that this trial, which was initially listed on March 1st 2023, is actively recruiting participants. 33 individuals are needed to participate from a single medical site."

Answered by AI

Is the age requirement for this trial flexible enough to accept participants aged 70 and over?

"The requirements to become a participant in this research include being between 1 Month and 39 years old. 32 trials are available for minors, while 15 focus on elderly individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy

2023. "Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05756660.