Trial Outcomes & Findings for Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin (NCT NCT04541355)

Last Updated: 2024-06-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Up to 7 weeks

Results posted on

2024-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Cisplatin, Radiotherapy, STS Participants 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.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin, Radiotherapy, STS n=16 Participants Participants 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.
Age, Customized 40-49 years old	3 Participants n=99 Participants
Age, Customized 50-59 years old	6 Participants n=99 Participants
Age, Customized 60-69 years old	4 Participants n=99 Participants
Age, Customized 70-79 years old	3 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	16 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	14 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	16 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 7 weeks

Outcome measures

Outcome measures
Measure	Cisplatin, Radiotherapy, STS n=16 Participants Participants 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.
Number of Participants Who Successfully Completed Planned Treatment	15 Participants

SECONDARY outcome

Timeframe: Up to 18 weeks

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.

Outcome measures

Outcome measures
Measure	Cisplatin, Radiotherapy, STS n=16 Participants Participants 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.
Proportion of Participants With Reported High Grade Ototoxicity	0.18 proportion of participants

SECONDARY outcome

Timeframe: Up to 18 weeks

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'.

Outcome measures

Outcome measures
Measure	Cisplatin, Radiotherapy, STS n=16 Participants Participants 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.
Number of Participants Reporting Tinnitus by Severity None	4 participants
Number of Participants Reporting Tinnitus by Severity Mild	7 participants
Number of Participants Reporting Tinnitus by Severity Moderate	4 participants
Number of Participants Reporting Tinnitus by Severity Severe	1 participants
Number of Participants Reporting Tinnitus by Severity Very Severe	0 participants

SECONDARY outcome

Timeframe: Up to 18 weeks

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.

Outcome measures

Outcome measures
Measure	Cisplatin, Radiotherapy, STS n=16 Participants Participants 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.
Percentage of Participants Reporting Sodium Thiosulfate (STS)-Specific Symptomology	100 percentage of participants

SECONDARY outcome

Timeframe: Up to 18 weeks

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

Outcome measures

Outcome measures
Measure	Cisplatin, Radiotherapy, STS n=16 Participants Participants 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.
Frequency of Hearing Handicap Suggesting no handicap	11 Participants
Frequency of Hearing Handicap Suggesting a mild-moderate handicap	5 Participants
Frequency of Hearing Handicap Suggesting significant hearing handicap	0 Participants

Adverse Events

Cisplatin, Radiotherapy, STS

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cisplatin, Radiotherapy, STS n=16 participants at risk Participants 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.
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 1 • Up to 18 weeks

Other adverse events

Other adverse events
Measure	Cisplatin, Radiotherapy, STS n=16 participants at risk Participants 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.
Gastrointestinal disorders Abdominal Pain	6.2% 1/16 • Up to 18 weeks
Immune system disorders Allergic Reaction	6.2% 1/16 • Up to 18 weeks
Blood and lymphatic system disorders Anemia	18.8% 3/16 • Up to 18 weeks
Metabolism and nutrition disorders Anorexia	18.8% 3/16 • Up to 18 weeks
Nervous system disorders Aphonia	6.2% 1/16 • Up to 18 weeks
Cardiac disorders Atrial fibrillation	6.2% 1/16 • Up to 18 weeks
Blood and lymphatic system disorders Blood and lymphatic system disorders, Other	6.2% 1/16 • Up to 18 weeks
Investigations Blood bilirubin increased	6.2% 1/16 • Up to 18 weeks
Psychiatric disorders Confusion	6.2% 1/16 • Up to 18 weeks
Gastrointestinal disorders Constipation	37.5% 6/16 • Up to 18 weeks
Investigations Creatinine increased	18.8% 3/16 • Up to 18 weeks
Gastrointestinal disorders Diarrhea	12.5% 2/16 • Up to 18 weeks
Nervous system disorders Dizziness	12.5% 2/16 • Up to 18 weeks
Gastrointestinal disorders Dry Mouth	31.2% 5/16 • Up to 18 weeks
Nervous system disorders Dysgeusia	43.8% 7/16 • Up to 18 weeks
Gastrointestinal disorders Dysphagia	37.5% 6/16 • Up to 18 weeks
Ear and labyrinth disorders Ear Pain	6.2% 1/16 • Up to 18 weeks
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 2/16 • Up to 18 weeks
General disorders Fatigue	31.2% 5/16 • Up to 18 weeks
Blood and lymphatic system disorders Neutropenia	18.8% 3/16 • Up to 18 weeks
Gastrointestinal disorders Gastrointestinal disorders, Other	31.2% 5/16 • Up to 18 weeks
Nervous system disorders Headaches	12.5% 2/16 • Up to 18 weeks
Ear and labyrinth disorders Hearing impaired	6.2% 1/16 • Up to 18 weeks
Respiratory, thoracic and mediastinal disorders Hiccups	12.5% 2/16 • Up to 18 weeks
Skin and subcutaneous tissue disorders Hyperhidrosis	6.2% 1/16 • Up to 18 weeks
Vascular disorders Hypertension	6.2% 1/16 • Up to 18 weeks
Metabolism and nutrition disorders Hypoalbuminemia	6.2% 1/16 • Up to 18 weeks
Metabolism and nutrition disorders Hypokalemia	6.2% 1/16 • Up to 18 weeks
Metabolism and nutrition disorders Hypomagnesemia	6.2% 1/16 • Up to 18 weeks
Injury, poisoning and procedural complications Infusion Related Reaction	18.8% 3/16 • Up to 18 weeks
Investigations Investigations, Other	6.2% 1/16 • Up to 18 weeks
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	25.0% 4/16 • Up to 18 weeks
Blood and lymphatic system disorders Lymph Node Pain	12.5% 2/16 • Up to 18 weeks
Investigations Lymphocyte count decreased	6.2% 1/16 • Up to 18 weeks
Nervous system disorders Memory impairment	6.2% 1/16 • Up to 18 weeks
Gastrointestinal disorders Mucositis oral	25.0% 4/16 • Up to 18 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal, Other	6.2% 1/16 • Up to 18 weeks
Gastrointestinal disorders Nausea	50.0% 8/16 • Up to 18 weeks
Investigations Neutrophil Count Decreased	12.5% 2/16 • Up to 18 weeks
Gastrointestinal disorders Oral pain	6.2% 1/16 • Up to 18 weeks
Nervous system disorders Paresthesia	6.2% 1/16 • Up to 18 weeks
Skin and subcutaneous tissue disorders Rash	6.2% 1/16 • Up to 18 weeks
Gastrointestinal disorders Rectal hemorrhage	6.2% 1/16 • Up to 18 weeks
Ear and labyrinth disorders Tinnitus	37.5% 6/16 • Up to 18 weeks
Respiratory, thoracic and mediastinal disorders Sore throat	31.2% 5/16 • Up to 18 weeks
Musculoskeletal and connective tissue disorders Trismus	6.2% 1/16 • Up to 18 weeks
Respiratory, thoracic and mediastinal disorders Voice alteration	6.2% 1/16 • Up to 18 weeks
Gastrointestinal disorders Vomiting	18.8% 3/16 • Up to 18 weeks
Metabolism and nutrition disorders Weight Loss	31.2% 5/16 • Up to 18 weeks

Additional Information

Dr. Hyunseok Kang, MD

University of California, San Francisco

Phone: (888) 689-8273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place