Prevalence and Impact on QoL From Ototoxicity in Cancer Survivors

NCT04270916 | Suspended

• 1 other identifier: 19039
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study will involve collaborating with oncologists in the post-chemotherapy follow-up appointments. The participants who wish to consent to this study will then answer 3 short questionnaires (THI, HHIA and SF-36) about hearing loss, tinnitus and quality of life. The audiologist or the researcher, under the supervision of an audiologist, will then perform a simple, non-invasive hearing test on the participant. Should the participant have a hearing loss, they will be advise to seek help from their General Practitioner.

Conditions

Hearing Loss, Sensorineural; Tinnitus, Subjective; Cancer; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• Quality of life questionnaire

  Short form 36 item questionnaire to assess quality of life (0-100 scale, higher score means better outcome)

  Afer 6 months

Secondary Outcomes (3)

• Hearing loss

  After 6 months

• Hearing Handicap Inventory for adults/elderly

  After 6 months

• Tinnitus Handicap Inventory

  After 6 months

Interventions

High frequency pure tone audiometry DIAGNOSTIC_TEST

Hearing test carried out routinely, non invasive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We aim to identify the prevalence of hearing loss and tinnitus and the impact on quality of life in people who have been treated with platinum based chemotherapy anywhere from 0-5 years ago. They can have any type of cancer as long as they were adults at the time of diagnosis and were treated with cisplatin, carboplatin or oxaliplatin.

You may qualify if:

• Ability to give informed consent
• Age 18+ at time of cancer diagnosis
• At least 1 cycle of any type of platinum-based chemotherapy
• years following first cycle of platinum-based chemotherapy
• Comprehensive understanding of the English language

You may not qualify if:

• Previous radiotherapy to the head and neck area
• Pre-existing hearing deficits

Sponsors & Collaborators

• University of Nottingham: lead
• National Institute for Health Research, United Kingdom: collaborator
• International Stem Cell Forum: collaborator

Study Sites (1)

Nottingham University Hospitals NHS trust

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Tinnitus; Neoplasms

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: February 3, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)