Association Between Tinnitus and Hearing Loss in Locally Advanced Head and Neck Cancer Treated by Radiotherapy Alone or With Chemotherapy: a Prospective and Multicenter Study

NCT05946577 | Not Yet Recruiting

• 2 other identifiers: APHP230058IDRCB 2022-A02685-38
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the AURACCO study is to evaluate the association between the onset of tinnitus and hearing loss in patients with locally advanced head and neck cancer treated by concomitant chemoradiotherapy or exclusive radiotherapy

Conditions

Head Cancer; Neck Cancer

Keywords

Head and neck cancer; HNSCC; Undifferentiated nasopharyngeal cancer; UCNT; Salivary gland cancer; Radiotherapy; Chemoradiotherapy; Radiochemotherapy; Chemotherapy; Cisplatin; Ototoxicity; Tinnitus; Hearing loss

Outcome Measures

Primary Outcomes (1)

• Association between the onset of tinnitus and hearing loss at 3 months after treatment

  Evaluation of the tinnitus on each ear. Hearing loss is defined as a loss of more than 20 dB compared to the measurement made at inclusion

  3 months after treatment

Secondary Outcomes (10)

• Tinnitus incidence

  at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months

• Hearing loss incidence

  at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months

• Association between the onset of tinnitus and/or hearing loss and quality of life

  at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months

• Association between the onset of tinnitus and/or hearing loss and quality of life

  at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months

• Association between the onset of tinnitus and/or hearing loss and quality of life

  at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months

Study Arms (2)

Patients treated by chemoradiotherapy with high dose of cisplatin

radiotherapy 60-70 Gy in 30-35 fractions with concomitant chemotherapy by cisplatin 100 mg/m2 every 3 weeks (week 1, 3 and 7)

Patients treated with exclusive radiotherapy or radiotherapy with non-ototoxic chemotherapy

patient ineligible for chemotherapy with cisplatin: * exclusive radiotherapy: 60-70 Gy in 30-35 fractions * radiotherapy with a non-ototoxic chemotherapy (due to contraindication to cisplatin): 60-70 Gy in 30-35 fractions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in Hôpital Tenon, Hôpital Pitié-Salpétrière, Hôpital Saint-Louis or Hôpital Européen Georges Pompidou for a histological diagnosis of locally advanced head and neck cancer with an indication for concomitant chemoradiotherapy or exclusive radiotherapy.

You may qualify if:

• Patient with locally advanced or post-operative ENT cancer with high risk of recurrence
• Patient ≥ 18 years
• Absence of prior chemotherapy or radiotherapy
• Patient eligible for chemotherapy with cisplatin according to the standard regimen: radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with chemotherapy with cisplatin 100 mg/m2 every 3 weeks (i.e. at week 1, 4 and 7)
• Patient ineligible for cisplatin chemotherapy receiving:
• Either exclusive radiotherapy (age \> 70 years, contraindication: renal failure, patient wearing a device): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks.
• either chemoradiotherapy with a chemotherapy protocol different from the standard scheme (due to a contraindication to cisplatin): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with non-standard chemotherapy ototoxic (cetuximab or carboplatin-5FU)

You may not qualify if:

• Tinnitus grade ≥ 2 according to the SOMA-LENT scale
• Patient fitted for hearing disorders
• Significant cognitive disorders that may compromise the performance of the various assessments
• Patients treated with weekly cisplatin
• Patient's refusal to participate in research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Radiotherapy Oncology Service TENON Hospital

Paris, 75020, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms; Ototoxicity; Tinnitus; Hearing Loss

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Florence HUGUET, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence HUGUET, MD, PhD

CONTACT

0033 (0) 1 56 01 62 10; Florence.huguet@aphp.fr

Rafik NEBBACHE, Resident

CONTACT

Rafik.nebbache@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: July 14, 2023
• Study Start: July 1, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

FR (1)