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  • High-Dose Prophylactic Gabapentin (HOPE) To Prevent Opioid Use For Oral Mucositis Pain During Head And Neck Chemoradiotherapy: A Phase III Clinical Trial Albert Lea, MN Scottsdale/Phoenix, AZ Eau Claire, WI La Crosse, WI Mankato, MN Rochester, MN This phase III trial tests if gabapentin can prevent the need for opiate pain medication for mouth sores (oral mucositis) in patients undergoing treatment with chemotherapy and radiation for squamous cell carcinoma of the head and neck region. Oral mucositis is a common side effect of radiation treatment and can cause severe pain, dysphagia, and weight loss resulting in feeding tube placement, worse health-related quality of life, treatment interruptions, unplanned hospitalizations, and significant financial burden. Mucositis pain is often treated with opioid pain medications which do provide pain relief but have many known side effects not limited to mental clouding, constipation, fatigue, endocrinopathy, neurotoxicity, sleep-disordered breathing, and most distressingly persistent opioid use. Gabapentin may help relieve pain from oral mucositis caused by radiation while also reducing the need for opiate pain medications for patients receiving chemotherapy and radiation for squamous cell carcinoma of the head and neck region

Closed for Enrollment

  • HEADLIGHT: Hypofractionated Proton Therapy For Head And Neck Cancers Albert Lea, MN Scottsdale/Phoenix, AZ Eau Claire, WI Jacksonville, FL La Crosse, WI Mankato, MN Rochester, MN

    This study utilizes a shorter course of radiotherapy for patients who need radiation after surgery or without surgery for head and neck cancers. Radiation is typically given in 6-7 weeks for head and neck cancer using X-ray therapy, but this study will administer treatment in approximately 3 weeks. To achieve this shorter course, proton therapy is used. This study aims to determine cancer control at 2 years after study registration. It also aims to determine the rate and duration of grade 3 or higher acute (defined from treatment start to 30 days from radiation completion date) adverse events and estimate acute toxicity burden using T-score and to determine the incidence of secondary acute effects attributable to radiotherapy including incidence of PEG tube placement, duration and dose of narcotic analgesia required, weight loss, hospitalization days, and time away from work. Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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