Phase 1b clinical trial testing whether cimetidine prevents hearing loss from cisplatin chemotherapy in head and neck cancer patients

Phase Ib randomised, placebo-controlled, double-blinded trial using Cimetidine to prevent the Oto-, Nephro- and neuro-toxicity of Cisplatin by OCT2 inhibition in patients undergoing chemoradiation for head and neck cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000877280

Acronym

CONCOCT

Enrollment

Registered

2018-05-23

Start date

2019-08-15

Completion date

Unknown

Last updated

2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with cancers of the head and neck are often cured with cisplatin chemotherapy and radiotherapy but this can lead to permanent reduction in hearing and kidney function. This trial will study if the drug cimetidine can protect kidneys and hearing from damage due to cisplatin chemotherapy in patients having this treatment for head and neck cancer. If cimetidine is found to be protect against these side effects in this group of patients, further trials will be undertaken to see if it may also be helpful to the many adults and children receiving cisplatin chemotherapy for other types of cancer.

Interventions

Patients will take cimetidine 800mg (2 x 400mg capsules) orally 30 minutes before, and again 90 minutes after, the start of each cisplatin infusion. This will be repeated every 3 weeks for 3 cycles of chemotherapy. The study medication will be administered under nursing supervision.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

• pathologically-confirmed locally-advanced HNSCC for which concurrent chemoradiation using cisplatin 100mg/m2 every 3 weeks for 3 cycles is planned • adequate baseline renal function (estimated glomerular filtration rate >60 ml/min) • adequate baseline hepatic and bone marrow function; • have signed written, informed consent

Exclusion criteria

• planned to receive platinum-based chemotherapy before or after radiation • prior chemotherapy with cisplatin or platinum analogues • existing hearing loss > 50 dB between 2000 and 8000 Hz, or hearing aids needed • radiation treatment plan would result in a cochlear dose > 45 Gy in either ear • allergic to cimetidine • taking drugs that are substrates of OCT2 (organic cation transporter type 2) unless the medication can safely be omitted on each day of cisplatin and cimetidine administration • taking medications with which cimetidine is known to have clinically-significant drug-drug interactions • congenital or acquired long QT syndrome • co-morbidities that would preclude cisplatin use, such as cardiac failure • pregnant or breastfeeding.

Outcome results