Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
250
Countries
1
Sites
1
Cancer
To assess the short-term effect of different cancer treatments on speech perception in noise.
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Oct 2024 → ongoing
- Decision date (initial)
- 2024-07-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Other non-profit foundations supporting scientific research · Turku University Hospital Foundation · The Wellbeing Services County of South West Finland State research funding · Finnish Audiological Society Research Funding · The Finnish ORL-HNS Foundation (Korvatautien tutkimussäätiö)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
To assess the short-term effect of different cancer treatments on speech perception in noise.
Secondary objectives 5
- To investigate the long-term (1 and 3 years post-treatment) effects of four different type of cancer treatments in speech perception in noise.
- To investigate the effects of different cancer treatments on high frequency (8-16kHz) hearing.
- To investigate the effects of different cancer treatments on hearing-related quality of life.
- To investigate the effects of head and neck cancer treatments on brain in the FDG PET images.
- To investigate to effect of different cancer treatments on cognition by translating the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) in Finnish and comparing the results to standard neuropsychological assessments.
Conditions and MedDRA coding
Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
| 20.0 | PT | 10062124 | Testicular seminoma (pure) | 100000004864 |
| 21.1 | PT | 10067821 | Head and neck cancer | 100000004864 |
| 21.1 | LLT | 10029557 | Non-seminoma testicular cancer | 10029104 |
| 26.1 | LLT | 10018017 | Gastrointestinal tract cancer NOS | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age 18-75
- Diagnosis of a cancer that will be treated with a curative intent with either cisplatin, oxaliplatin, cisplatin-based chemoradiation therapy of the head and neck region or radiation therapy of the head and neck region (subjects in the treatment groups)
- Age-normative hearing (according to the ISO standard 7029:2017)
- Ability to provide written informed consent
- Native Finnish speaker
Exclusion criteria 9
- Inability to provide written informed consent
- Current or prior major otological condition that has affected or had the potential to affect hearing
- Conductive hearing loss or asymmetric hearing loss of any severity
- Severe sensorineural hearing loss
- Prior malignancy that has been treated with chemotherapeutics and/or radiation therapy
- Prior use of ototoxic medication
- Any condition that, in the opinion of the investigator, would interfere with adherence to study requirements
- Pregnancy, breast-feeding, or aim of becoming pregnant during the study
- Allergy or hypersensitivity to study medications or their ingredients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The change in speech perception in noise (measured with the Finnish matrix sentece test) from the baseline to the first follow-up visit at 3-4 months after the end the initial treatment
Secondary endpoints 4
- Long-term change in the speech perception in noise
- Short- and long-term change in extended high frequency hearing
- Hearing-related quality of life
- Changes in Functional Assessment of Cancer Therapy - Cognitive Function questionnaire and in standardized neuropsychological tests
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Cisplatin Accord 1 mg/ml infuusiokonsentraatti, liuosta varten
PRD1951579 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 27103
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin Accord 5 mg/ml, infuusiokonsentraatti, liuosta varten.
PRD1785481 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 130 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1040 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- 26943
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
Gemcitabine Accord 100 mg/ml infuusiokonsentraatti, liuosta varten
PRD1980152 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- 29406
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Capecitabine Orion 500 mg kalvopäällysteiset tabletit
PRD1625261 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 224000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- 31392
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Holoxan injektio-/infuusiokuiva-aine, liuosta varten
PRD310936 · Product
- Active substance
- Ifosfamide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m2 milligram(s)/square meter
- Max total dose
- 24000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AA06 — IFOSFAMIDE
- Marketing authorisation
- 10120
- MA holder
- BAXTER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Uromitexan cum conservans 100 mg/ml injektioneste, liuos
PRD321536 · Product
- Active substance
- Mesna
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 24000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- V03AF01 — MESNA
- Marketing authorisation
- 15581
- MA holder
- BAXTER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bleomycin Baxter 15 000 KY injektio-/infuusiokuiva-aine, liuosta varten
PRD344825 · Product
- Active substance
- Bleomycin Sulfate Ph. Eur.
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30000 IU international unit(s)
- Max total dose
- 360000 IU international unit(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- 6412
- MA holder
- BAXTER OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Etoposide Accord 20 mg/ml Infuusiokonsentraatti, liuosta varten
PRD1800151 · Product
- Active substance
- Etoposide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 4000 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- 31358
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Savitehtaankatu 1
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- Tytti Willberg
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Tytti Willberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 250 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2024-10-02 | 2024-10-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-14 | Finland | Acceptable 2024-07-18
|
2024-07-26 |