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Cisplatin can permanently damage a child's hearing. For many children whose cancer has not spread, a drug called sodium thiosulfate, given as a short drip six hours after each dose of cisplatin, roughly halves the chance of hearing loss. Hearing is tested during treatment and for years after, and any loss is referred to a hearing specialist.
The international guideline (Freyer et al., 2020, GRADE, endorsed by the Children's Oncology Group in August 2020) covers children and adolescents aged 0 to 18 receiving cisplatin. Sodium thiosulfate: use it in non-metastatic hepatoblastoma (strong, high quality, from SIOPEL 6, where any hearing loss fell from 63% to 33% with no loss of survival); consider it in other non-metastatic cancers (weak, low); and do not use it routinely in metastatic cancers (weak, low), because in the post-hoc metastatic subgroup of ACCL0431 3-year overall survival was 45% with it against 84% without, an estimate the panel judged open to bias and asked to be discussed with families. Do not use amifostine (strong, high), sodium diethyldithiocarbamate (strong, low) or intratympanic therapy (strong, low), and do not change the cisplatin infusion length to protect hearing (strong, low), except that sodium thiosulfate needs cisplatin infusions of 6 hours or less.
The US label for PEDMARK limits it to children aged 1 month or older with localised, non-metastatic solid tumours, gives it over 15 minutes starting 6 hours after each cisplatin infusion and at least 10 hours before the next, doses by weight-based surface area, and says not to start it with a serum sodium above 145 mmol/L. The IGHG recommends hearing surveillance from the end of treatment at the latest: yearly under 6 years, every other year from 6 to 12, and every 5 years over 12, with pure-tone audiometry at 1000 to 8000 Hz from age 6 and a referral for any loss of more than 15 dB.
Why: Hearing loss from cisplatin often starts in the high pitches a child does not notice, so it has to be measured.
“Surveillance is usually mandatory for at-risk patients during treatment.”
Why: In the SIOPEL 6 trial hearing loss fell from 63% to 33% of children, and survival was not reduced.
“Use sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in children and adolescents with non-metastatic hepatoblastoma”
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Strong, high quality
Why: Hearing protection should not depend on the type of cancer, but the survival evidence outside hepatoblastoma is less certain.
“Consider sodium thiosulfate for the prevention of cisplatin-induced ototoxicity in children and adolescents with non-metastatic cancers other than hepatoblastoma”
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Weak, low quality
Why: In one trial, children with metastatic disease who had it survived less often; that finding may be due to chance or bias, so the family's values matter.
“We suggest sodium thiosulfate not be used routinely for the prevention of cisplatin-induced ototoxicity for children and adolescents with metastatic cancers”
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Weak, low quality
Why: Babies this young control their blood sodium less well, and the drug raises the risk of sodium going too high.
“PEDMARK is not indicated and not recommended for use in pediatric patients younger than 1 month of age.”
Fennec Pharmaceuticals, via DailyMed (US National Library of Medicine) 2025
Why: Both trials used cisplatin infusions of 6 hours or less; after a longer infusion the damage may already be done.
“However, if sodium thiosulfate is to be introduced as an otoprotectant, then the cisplatin infusion will need to be 6 h or less, as was required in the SIOPEL 6 and ACCL0431 trials.”
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020
Why: The drug can push sodium too high and potassium too low.
“Do not initiate PEDMARK infusions in patients with baseline serum sodium greater than 145 mmol/L”
Fennec Pharmaceuticals, via DailyMed (US National Library of Medicine) 2025
Why: This is the timing both trials used and the label sets; the guideline says that if sodium thiosulfate is used it should be given the same way.
“Administer PEDMARK as an intravenous infusion over 15 minutes starting 6 hours after completion of cisplatin infusion.”
Fennec Pharmaceuticals, via DailyMed (US National Library of Medicine) 2025
Why: The gap stops the protector being in the blood when the next dose of cisplatin is given.
“Do not administer PEDMARK if the next cisplatin infusion is scheduled to begin in less than 10 hours”
Fennec Pharmaceuticals, via DailyMed (US National Library of Medicine) 2025
Why: Five trials, two of them in children, showed no benefit, and it causes low calcium, sickness and low blood pressure.
“Do not use amifostine for the prevention of cisplatin-induced ototoxicity in children and adolescents with cancer”
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Strong, high quality
Why: Neither showed a benefit that mattered, both have harms or practical problems, and the ear injections are hard to repeat in children.
“Do not use intratympanic middle ear therapy for the prevention of cisplatin-induced ototoxicity in children and adolescents with cancer”
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Strong, low quality
Why: The two trials that tested infusion length did not show it changes hearing loss.
“Do not alter cisplatin infusion duration, as a means in itself, to reduce ototoxicity in children and adolescents with cancer”
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Strong, low quality
Why: Hearing loss can appear or worsen years later, and young children are still learning to speak.
“consensus among the guideline panel was that surveillance in survivors should start no later than the end of treatment and should be done annually for children younger than 6 years of age, every other year for children 6–12 years of age, and every 5 years for adolescents and young adults older than 12 years”
IGHG and PanCare, The Lancet Oncology 2019 · strong (level A and B evidence for cisplatin)
Why: Pure-tone tests are the standard measure once a child can do them; younger children need a specialist's methods.
“The guideline panel recommends that pure-tone audiometry at 1000–8000 Hz is the gold standard for routine surveillance of CAYA cancer survivors aged 6 years or older to avoid over-testing”
IGHG and PanCare, The Lancet Oncology 2019 · strong recommendations
Why: Hearing aids, remote microphones and support at school reduce the effect on speech and learning.
“The guideline panel strongly recommends (based on expert opinion) that referral to an audiologist, auditory clinic, or ear, nose, and throat physician as appropriate for any survivor who has symptoms suggesting hearing loss, atypical audiological test results showing a loss of more than 15 dB at 1000–8000 Hz, or both.”
IGHG and PanCare, The Lancet Oncology 2019 · strong (expert opinion)
How care is usually carried out, read from the guidelines and standards cited. Your own team's protocol and their judgement come first; this page is for understanding it, not for doing it yourself.
The 2020 international guideline (Freyer et al.), endorsed by the Children's Oncology Group, is the only guideline on preventing cisplatin hearing loss in children and has not been replaced: sodium thiosulfate for non-metastatic hepatoblastoma (strong), considered for other non-metastatic cancers (weak), not routinely in metastatic cancers (weak), and no amifostine, sodium diethyldithiocarbamate, intratympanic therapy or change of infusion length. The US label for PEDMARK sets the practical limits the guideline leaves open: age 1 month or older, localised non-metastatic solid tumours, cisplatin infusions of 1 to 6 hours, a 15-minute infusion 6 hours after cisplatin and at least 10 hours before the next dose. The two trials used different doses (20 g/m2 in SIOPEL 6, 16 g/m2 in ACCL0431); the guideline accepts either, and the label doses by weight band. Surveillance follows the IGHG and PanCare recommendations, which say the use of an otoprotectant does not change the surveillance schedule.
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Children's Oncology Group 2020 · Fennec Pharmaceuticals, via DailyMed (US National Library of Medicine) 2025 · IGHG and PanCare, The Lancet Oncology 2019
Where it differs: Some families and teams choose sodium thiosulfate for a child with metastatic cancer, for example where the child is blind and hearing is the main sense, after the survival uncertainty is explained.
Evidence: The guideline's weak recommendation against routine use was made weak at the patient representatives' request so that it could be discussed; the panel names a child with blindness as a case where benefit probably outweighs risk. The US label does not cover metastatic cancer.
International panel (Pediatric Oncology Group of Ontario), The Lancet Child & Adolescent Health 2020 · Fennec Pharmaceuticals, via DailyMed (US National Library of Medicine) 2025
Shares Children's Oncology Group (COG), Childhood cancers (all types), Late effects and survivorship toxicity and the tags protocol, paediatric.
Shares Children's Oncology Group (COG), Childhood cancers (all types), Cisplatin and the tags protocol, paediatric.
Shares Children's Oncology Group (COG), Childhood cancers (all types) and the tags protocol, paediatric.
Shares Children's Oncology Group (COG), Childhood cancers (all types) and the tags protocol, paediatric.
Shares Children's Oncology Group (COG), Childhood cancers (all types) and the tags protocol, paediatric.
Shares Children's Oncology Group (COG), Childhood cancers (all types) and the tags protocol, paediatric.
Shares Sodium thiosulfate (otoprotectant), Hearing and tinnitus after platinum chemotherapy, Hepatoblastoma, Germ cell tumours of childhood and adolescence (extracranial and CNS).
Shares Children's Oncology Group (COG), Childhood cancers (all types) and the tags protocol, paediatric.