NCT04541355 · REGISTRY CONDITION SEARCH

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-06-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Who Successfully Completed Planned Treatment

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outcome · POSTED

Proportion of Participants With Reported High Grade Ototoxicity

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outcome · POSTED

Number of Participants Reporting Tinnitus by Severity

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outcome · POSTED

Percentage of Participants Reporting Sodium Thiosulfate (STS)-Specific Symptomology

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outcome · POSTED

Frequency of Hearing Handicap

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Participants must have histologically or cytologically confirmed locoregionally advanced squamous cell carcinomas of mucosal surfaces of head and neck who are being treated with concurrent chemoradiation with cisplatin 2. Participants must be eligible for cisplatin-based concurrent chemotherapy in conjunction with at least 6 weeks of daily fractionated radiation therapy 3. Age \>=18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%) 5. Demonstrates adequate organ function as defined below: 1. Absolute neutrophil count \>= 1,000/microliter (mcL) 2. Platelets \>= 100,000/mcL 3. Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits 4. Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =\< 3 X institutional upper limit of normal 5. Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =\< 3 X institutional upper limit of normal 6. Creatinine =\< 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\^2 6. Ability to understand a written informed consent document, and the willingness to sign it 7. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial 8. The effects of sodium thiosulfate (STS) on the developing human fetus are unknown. For this reason and because cisplatin used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception such as hormonal and/or barrier method of birth control for the duration of study participation and for 3 months after last administration of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after last administration of study treatment Exclusion Criteria: 1. Participants that are not eligible for cisplatin-based chemoradiation for reasons such as chronic kidney disease, severe hearing loss, and severe peripheral neuropathy 2. Uncontrolled inter-current illness or psychiatric illness/social situation that would limit compliance with study requirements 3. Has known hypersensitivity to cisplatin, sodium thiosulfate or any of its excipients 4. Has profound hearing impairment at baseline and cannot hear a sound below 90 decibels (dB) 5. Participants with uncompensated congestive heart failure New York Heart Association (NYHA) class 3 or above 6. Participants who cannot get secure venous access using either a Mediport or a peripherally inserted central catheter (PICC) line for safe administration of intravenous sodium thiosulfate 7. Pregnant women are excluded from this study because cisplatin is a cytotoxic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin or sodium thiosulfate, breastfeeding should be discontinued if the mother is treated with either agent
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients undergo standard of care radiation therapy daily in combination with cisplatin on day 1. Between 4-5 hours after each cisplatin infusion, patients also receive sodium thiosulfate over 1-2 hours on day 1. Treatment will continue on either a 1 week or 3 week cycle per physician discretion for up to 6-7 weeks in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: Cisplatin
Other: Hearing Handicap Inventory for Adults - Screening
Radiation: Radiation Therapy
Drug: Sodium Thiosulfate
label
Cisplatin, Radiotherapy, STS
type
EXPERIMENTAL

interventions

arm Group Labels
Cisplatin, Radiotherapy, STS
description
Given IV
name
Cisplatin
other Names
Abiplatin
Blastolem
Briplatin
CDDP
Cis-diammine-dichloroplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
type
DRUG
arm Group Labels
Cisplatin, Radiotherapy, STS
description
Patient self-assessment questionnaire to measure probability of hearing impairment
name
Hearing Handicap Inventory for Adults - Screening
type
OTHER
arm Group Labels
Cisplatin, Radiotherapy, STS
description
Radiation therapy will be delivered according to the standard of care
name
Radiation Therapy
other Names
Cancer Radiotherapy
Irradiate
Irradiated
Irradiation
Radiation
Radiation Therapy, Not otherwise specified (NOS)
Radiotherapeutics
Radiotherapy
RT
type
RADIATION
arm Group Labels
Cisplatin, Radiotherapy, STS
description
Given IV
name
Sodium Thiosulfate
other Names
Cyanide Antidote Package
Disodium Thiosulfate
S-Hydril
Sodium Hyposulfate
Sodium Thiosulfate Pentahydrate
Sodium Thiosulphate
Sodothiol
Thiosulfate, Sodium, Pentahydrate
Thiosulfuric Acid Disodium Salt
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 16
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Evaluated as the successful completion of at least 5 weekly cisplatin or 2 high dose cisplatin without any extended treatment related delays more than 7 days. Overall successful completion is defined as completion by at least 75% of patients.
measure
Number of Participants Who Successfully Completed Planned Treatment
time Frame
Up to 7 weeks

secondary Outcomes

description
The proportion of participants with a reported change of grade \>= 2 hearing impairments based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (for patients on a monitoring program with audiogram) will be reported.
measure
Proportion of Participants With Reported High Grade Ototoxicity
time Frame
Up to 18 weeks
description
The frequency of tinnitus will be measured by participants' worst level response at any time point on the PRO-CTCAE® question "In the last 7 days, what was the severity of ringing in your ears at its worst?". Item responses were categorized as 'None', 'Mild', 'Moderate', 'Severe', and 'Very Severe'.
measure
Number of Participants Reporting Tinnitus by Severity
time Frame
Up to 18 weeks
description
The percentage of participants reporting STS specific adverse events will be measured by affirmative responses on the PRO-CTCAE® on any of the selected oral, gastrointestinal, neurologic and visual/perceptual symptoms.
measure
Percentage of Participants Reporting Sodium Thiosulfate (STS)-Specific Symptomology
time Frame
Up to 18 weeks
description
The Hearing Handicap Inventory for Adults -Screener (HHIA-S), is a 10-item, self-assessment screening assessment developed to quickly determine the suggested level of hearing handicap. The participants respond to each of the items with a Yes (score of 4), Sometimes (score of 2), or No (score of 0). Total Scores are then summed for overall score (range 0-40) and then assigned a category for a suggested hearing handicap; 0-8 suggesting no handicap, 10-24 suggesting a mild-moderate handicap, and 26-40 suggesting significant hearing handicap. The frequency of participants for worse reported score will be reported
measure
Frequency of Hearing Handicap
time Frame
Up to 18 weeks

Full study description

brief 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.
detailed Description: PRIMARY OBJECTIVE: I. To establish feasibility of intravenous sodium thiosulfate (STS) after each dose of concurrent cisplatin in patients with locally advanced head and neck squamous cell carcinoma undergoing definitive radiotherapy. SECONDARY OBJECTIVES: I. To determine the rate of grade \>= 2 hearing impairment based on Common Terminology Criteria for Adverse Events (CTCAE) version 5 with use of STS after concurrent chemoradiation with cisplatin 3 months post-treatment. II. To determine the rate of tinnitus measured by Patient Reported Outcomes (PRO)-CTCAE with use of STS 3 months post-treatment. III. To describe patient reported outcomes with STS measured with PRO-CTCAE for selected oral, gastrointestinal (GI), neurologic and perceptual symptoms. IV. To describe patient reported outcomes measured with Hearing Handicap Inventory for Adults - Screening (HHIA-S) compared to results from standard NRG Oncology head and neck trials (such as Radiation Therapy Oncology Group (RTOG) 1016). OUTLINE: Patients undergo standard of care radiation therapy in combination with cisplatin therapy for up to 6-7 weeks. Cisplatin treatment repeats weekly for up to 7 cycles, or every 21 days for up to 3 cycles. After each cisplatin infusion, patients also receive an infusion of sodium thiosulfate. The dosing schedule for cisplatin will be at the discretion of the treating physician. After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice