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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)

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

Florence HUGUET, MD, PhD

Rafik NEBBACHE, Resident

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

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 :

* Patient data :
* Birth date (age at diagnosis)
* Tobacco use (active : yes/no, quantity in pack-year)
* Alcohol use (active : yes/no, quantity in g/day)
* Sex
* Disease data :
* Primitive site (oral cavity, nasopharynx, oropharynx, larynx, sinus, salivary gland, carcinoma with unknown primitive)
* Histological type
* HPV status
* TNM stage
* Data at diagnosis
* Treatment data :
* Post-operative situation (yes/no)
* Radiotherapy dose received and number of fraction
* Mean and max doses received in Gy on the right and left cochleas
* Other otototoxic treatment taken during radiotherapy
* Evaluation data :
* Tinnitus evaluation (using SOMA-LENT criteria)
* Audiogram with measures at 0,25, 0,5,

  1, 2, 4, 6, 8, 10 and 12,5 kHz
* Check for hearing "microloss"
* If tinnitus present : acouphénométrie
* If hearing aid fitting indication : APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire

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

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

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

According to Subjective, Objective, Management, Analytic- Late Effects Normal Tissue scales :SOMA-LENT scale (grade 1 to 4).

audiogram with measures at 0,25, 0,5, 1, 2, 4, 6, 8, 10 and 12,5 kHz

Evaluation quality of life (Tinnitus Handicap Inventory)

Evaluation quality of life: EVA intensity and discomfort

Evaluation quality of life: EQ-5D-5L questionnaire

APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire

Assistance Publique - Hôpitaux de Paris

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Neuroprotective Agents

Gastrointestinal Agents

Carboplatin

Ebselen

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Antacids

Anti-Ulcer Agents

Antioxidants

Protective Agents

Cyclooxygenase Inhibitors

Enzyme Inhibitors

200 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

400 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

600 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

0 mg SPI-1005, capsule, po, bid, x3d surrounding each cycle of chemotherapy

Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Arms: Low Dose

Other Names:

200 mg Ebselen

SPI-1005 Low Dose

Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

SPI-1005 Middle Dose

Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

SPI-1005 High Dose

Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy

Placebo

Eric Lynch, PhD

Tony S. Quang, M.D.

Tony S Quang, M.D.

Jonathan Kil, MD

Chemotherapy treatment with platinum based agents is well noted to cause ototoxicity. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy in head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

Chemotherapy treatment with the platinum containing chemotherapies (e.g. cisplatin, carboplatin) are well noted and studied for their ability to cause ototoxicity which includes hearing loss, tinnitus, vertigo, or dizziness. It is the objective of this study to determine the safety and efficacy of SPI-1005 at three dose levels when delivered orally twice daily for 3 days, surrounding each cycle of platinum chemotherapy for head and neck or non-small cell lung cancer patients to prevent and treat chemotherapy induced hearing loss and tinnitus.

SPI-1005, a proprietary oral formulation of ebselen is a small molecule mimic and inducer of the enzyme Glutathione Peroxidase. GPx reduces reactive oxygen species (ROS) by reacting with glutathione. SPI-1005 has been shown to reduce cisplatin induced hearing threshold shift in animal studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Head Cancer Neck Cancer		18 Years -	Assistance Publique - Hôpitaux de Paris
SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss	NCT01451853	Lung Cancer Head and Neck C... Hearing Loss Ototoxicity Tinnitus Neuropathy	SPI-1005 Low Do... SPI-1005 Middle... SPI-1005 High D... Placebo	19 Years - 80 Years	Sound Pharmaceuticals, Incorporated

Spots Global Cancer Trial Database for tinnitus

Every month we try and update this database with for tinnitus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tinnitus

Every month we try and update this database with for tinnitus cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tinnitus cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.