Alpha Lipoic Acid to Decrease Treatment Related Pain and Side Effects During Concurrent Chemoradiation in HNSCC
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- MTD and RP2D of ALA during chemoradiotherapy for HNSCC patients
研究概览
简要总结
This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.
详细描述
The study will be completed when the MTD and RP2D are determined. This will be either when 2 or more patients have a DLT at a particular dose level, or when 6 patients have completed treatment at the highest dose level (600 mg TID). The final 3 patients enrolled at the highest tolerated dose will also complete PK studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision to sign and date the consent form.
- •Stated willingness to comply with all study procedures and be available for the duration of the study.
- •Be a male or female aged 18-
- •Histologically or cytologically confirmed stage II-IVB HNSCC of the oral cavity, hypopharynx, oropharynx, larynx, or nasopharynx.
- •Ability to take medication orally or per feeding tube and be willing to adhere to the medication regimen.
- •Patients who are deemed appropriate for definitive, adjuvant, or palliative radiation with total planned dose > 30 Gy.
- •Patients who are deemed appropriate for concurrent systemic therapy with radiation including cisplatin (100 mg/m2 triweekly or 30-40 mg/m2 weekly), carboplatin (AUC 1-2 weekly) +/- paclitaxel (30 mg/m2 weekly) or cetuximab (400 mg/m2 loading followed by 250 mg/m2 weekly.
- •a. The final 3 patients in the dose expansion group undergoing the PK/PD study must be deemed appropriate for cisplatin.
- •For females of reproductive potential: use of highly effective contraception including hormonal contraceptives, intrauterine devices (IUD), vasectomy, tubal ligation, and double barrier methods (combination of male condom, female condom, cervical cap, diaphragm, contraceptive sponge).
- •For males of reproductive potential: use of condoms.
- •ECOG performance status ≤ 2.
排除标准
- •Participation in another clinical study with an investigational product during the last 30 days.
- •Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study, a clinical study not involving pharmaceutical or radiation techniques, or during the follow-up period of an interventional study.
- •Women who are pregnant or lactating. Patients of reproductive potential must have a negative serum or urine pregnancy test within 72 hours of start of study drug.
- •Patients who are currently taking gabapentin, pregabalin, amitriptyline, nortriptyline, or duloxetine.
- •Known allergy or hyposensitivity to alpha lipoic acid.
- •Judgement by the investigator that the patient is unsuitable to participate in the study and the patient in unlikely to comply with study procedures, restrictions, and requirements.
研究组 & 干预措施
Alpha Lipoic Acid (ALA) during chemoradiation
Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation as standard of care will receive ALA before, during, and after treatment. The drug will have dose escalation in a 3+3 design. The first group of 3 patients will receive 600 mg twice a day. If there are no DLTs, the next 3 patients will receive the highest dose of 600 mg three times a day. If one or more patients develop a DLT at any of the dosing levels, the group will either be expanded or dropped to a lower dose level.
干预措施: Alpha Lipoic Acid (Drug)
结局指标
主要结局
MTD and RP2D of ALA during chemoradiotherapy for HNSCC patients
时间窗: 18 months
The maximum tolerated dose will be the highest dose in the planned schema that is given without evidence of SAEs. The RP2D will incorporate the MTD and PKs to determine the dose that is best tolerated as well as has the concentration necessary to be effective according to historical studies.
次要结局
- Total concurrent opioid use using patient reported diaries(From start of treatment to post-treatment surveillance scans, up to 6 months)
- Safety of ALA by following adverse events (AEs)(up to 18 months)
- Progression free survival (PFS)(Screening, 3 and 6 month follow up visits)
- Maximum plasma concentration of ALA at the MTD with chemoradiotherapy(At start of ALA, Day 1, and Day 15, for 3 dose expansion PK patients)
- Change in Oral Mucositis Assessment Scale (OMAS) from baseline(From start of treatment to post-treatment surveillance scans, up to 6 months)
- Change in Visual Assessment Score (VAS) for pain from baseline(From start of treatment to post-treatment surveillance scans, up to 6 months)
- Change in quality of life measures using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) during chemoradiation(From start of treatment to post-treatment surveillance scans, up to 6 months)
- Overall survival (OS)(From start of treatment up to 18 months)