Skip to content
← Full study record

NCT04541355 · OUTCOME

Frequency of Hearing Handicap

Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin · Source last updated 2024-06-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 18 weeks

What was measured

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

Groups in this outcome

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cisplatin, Radiotherapy, STS16

Reported measurements

Suggesting no handicap
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin, Radiotherapy, STS11Not reportedNot reportedNot reportedNot reported
Suggesting a mild-moderate handicap
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin, Radiotherapy, STS5Not reportedNot reportedNot reportedNot reported
Suggesting significant hearing handicap
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin, Radiotherapy, STS0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Suggesting no handicap
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Suggesting a mild-moderate handicap
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Suggesting significant hearing handicap
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
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
groups
  1. description
    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.
    id
    OG000
    title
    Cisplatin, Radiotherapy, STS
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 18 weeks
title
Frequency of Hearing Handicap
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice