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Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy
Phase 3 trial testing sodium thiosulfate in Brain Tumor in 131 participants. Completed in 30 June 2021.
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 131 |
| Start date | 23 June 2008 |
| Primary completion | 9 April 2015 |
| Estimated completion | 30 June 2021 |
| Sites | 76 locations across Canada, United States, Australia |
Children's Oncology Group — full company profile →
Adults 1 to 18, any sex, with Brain Tumor or Central Nervous System Tumor. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hearing loss defined by comparing hearing sensitivity at follow up evaluation relative to baseline measurements using ASHA criteria.
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | 14 | |
| Observation Arm | 31 |
Mean change in hearing threshold (post-pre) at 500 hz.
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | -1.45 | ± 5.80 |
| Observation Arm | -1.11 | ± 8.59 |
Mean change in hearing threshold (post-pre) at 1000 hz.
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | -0.676 | ± 4.59 |
| Observation Arm | -0.319 | ± 8.99 |
Mean change in hearing threshold (post-pre) at 2000 hz
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | -1.18 | ± 4.85 |
| Observation Arm | 0.638 | ± 12.7 |
Mean change in hearing threshold (post-pre) at 4000 hz.
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | 1.05 | ± 7.09 |
| Observation Arm | 9.58 | ± 20.5 |
Mean change in hearing threshold (post-pre) at 8000 hz.
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | 9.73 | ± 17.3 |
| Observation Arm | 17.0 | ± 24.7 |
Proportion of patients event free at 4 years following enrollment. See EFS outcome measure description.
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | 53.7 | 39.8 – 65.8 |
| Observation Arm | 61.4 | 48.0 – 72.3 |
Proportion of patients alive free at 4 years following enrollment. See OS outcome measure description.
| Group | Value | 95% CI |
|---|---|---|
| STS Arm (Sodium Thiosulfate Treatment) | 69.6 | 55.6 – 79.9 |
| Observation Arm | 82.0 | 68.4 – 90.1 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | STS Arm (Sodium Thiosulfat… | Observation Arm |
|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Neutrophil count decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Abdominal infection | Infections and infestations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Acidosis | Metabolism and nutrition disorders | — | — |
| Anaphylaxis | Immune system disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Conjunctivitis | Eye disorders | — | — |
| Depressed level of consciousness | Nervous system disorders | — | — |
| Extrapyramidal disorder | Nervous system disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Reaction | System | STS Arm (Sodium Thiosulfat… | Observation Arm |
|---|---|---|---|
| Neutrophil count decreased | Investigations | — | — |
| White blood cell decreased | Investigations | — | — |
| Platelet count decreased | Investigations | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — |
| Lymphocyte count decreased | Investigations | — | — |
| Hypernatremia | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Allergic reaction | Immune system disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — |
| Catheter related infection | Infections and infestations | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| GGT increased | Investigations | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — |
| Infusion related reaction | General disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Skin infection | Infections and infestations | — | — |
| Abdominal infection | Infections and infestations | — | — |
| Acidosis | Metabolism and nutrition disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Blood bilirubin increased | Investigations | — | — |
| Bone infection | Infections and infestations | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Confusion | Psychiatric disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Device related infection | Infections and infestations | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Enterocolitis infectious | Infections and infestations | — | — |
Most-reported serious reactions: Febrile neutropenia, Neutrophil count decreased, Platelet count decreased, White blood cell decreased, Anemia, Mucositis oral, Lymphocyte count decreased, Alanine aminotransferase increased.
Data from ClinicalTrials.gov NCT00716976 adverse events section.
RATIONALE: Sodium thiosulfate may reduce or prevent hearing loss in young patients receiving cisplatin for cancer. It is not yet known whether sodium thiosulfate is more effective than no additional treatment in preventing hearing loss. PURPOSE: This randomized phase III trial is studying sodium thiosulfate to see how well it works in preventing hearing loss in young patients receiving cisplatin for newly diagnosed germ cell tumor, hepatoblastoma, medulloblastoma, neuroblastoma, osteosarcoma, or other malignancy.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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