Association Between Tinnitus and Hearing Loss in Patients With Locally Advanced Head and Neck Cancer Treated by Concomitant Chemoradiotherapy or Exclusive Radiotherapy: a Prospective and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Association between the onset of tinnitus and hearing loss at 3 months after treatment
研究概览
简要总结
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
详细描述
Radiotherapy with or without concomitant chemotherapy is the standard of care for patients diagnosed with locally advanced head and neck cancer.
This treatment is associated with many side effects, especially tinnitus and hearing loss affecting patients' quality of life. Theses toxicities are due to chemotherapy and radiotherapy, with a synergic effect.
The effects of chemoradiotherapy on hearing loss are already well documented but very limited data are available on the onset of tinnitus.
Currently, no study established a correlation between tinnitus and hearing loss after treatment by chemoradiotherapy or exclusive radiotherapy. The main question we aim to answer is whether the development of tinnitus during treatment can be a precursor to hearing loss?
Clinical data will be collected prospectively in 4 centers in Paris (Hôpital Tenon, Hôpital La Pitié-Salpêtrrière, Hôpital Saint-Louis and Hôpital Européen Georges Pompidou) to collect :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Association between the onset of tinnitus and hearing loss at 3 months after treatment
时间窗: 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
次要结局
- 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)
- Quality of life after hearing aid fitting in patients requiring hearing aid during/after treatment(at 3 weeks, 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 radiotherapy dose received on the cochlea and hearing loss(3 months after treatment)
- Tinnitus incidence(at inclusion, at 3 weeks, at 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months)
- Evolution of hearing disorders (tinnitus and/or hearing loss)(at inclusion, at 3 weeks, 6 weeks, 3 months after treatment, 6 months, 12 months and 18 months)
- Association between cisplatin dose received and the onset of tinnitus and/or hearing loss(3 months after treatment)
- Association between radiotherapy dose received on the cochlea and the onset of tinnitus(3 months after treatment)