A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
研究概览
简要总结
D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.
This randomized, double-blind, placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.
详细描述
This is a randomized, double-blind, placebo-controlled study. Initially, patients were randomized to 1 of 2 treatment arms (D-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity.
Later, the design was changed to randomize patients to 1 of 3 arms as follows:
- D-cycloserine 50 mg twice daily for up to 12 weeks
- D-cycloserine 200 mg twice daily for up to 12 weeks
- Placebo twice daily for up to 12 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Patients will be at least 18 years of age.
- •Patients will be experiencing moderate to severe peripheral neuropathic pain
- •Patients may be on chronic adjuvant pain medications such as antidepressants but must be on stable doses for at least one week prior to admission.
- •Patients may be taking concurrent opioids but they must be willing to allow us to monitor their opioid use while on the trial.
- •Patients must have chronic peripheral neuropathic pain will be defined as pain of 3 or more months duration which began in association with chemotherapy.
- •Patient's will have bilateral peripheral neuropathic pain symptoms primarily involving the feet
- •Patients must have breast cancer (any stage)
- •Patients must be able to read and speak English and provide informed consent.
- •Patients may be receiving chemotherapy as long as the agents are not known to cause a peripheral neuropathy.
- •Patients must have an ECOG Performance Status < 3 and be able to attend the physician study visits
- •Patients must not concurrently use gabapentin or pregabalin or must be willing to wean off their anti-convulsant medications prior to starting the trial.
- •Patients may have diabetes mellitus (type 1 or 2) as long as there is no preexisting neuropathy.
- •Exclusion criteria:
- •Patients will not have secondary cause of neuropathic pain including: HIV/AIDS,traumatic injury, or a personal history of non chemotherapy-induced neuropathy.
- •Patients will not have a history of major depression or severe anxiety.
- •Women of childbearing age will agree to take measures to prevent pregnancy and will not breast-feed while on the study medication. Women who are currently pregnant will not be invited to participate in this study.
- •Patients will not have a history of seizures.
- •Patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g. isoniazid).
排除标准
- 未提供
研究组 & 干预措施
D-cycloserine 200mg
D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
干预措施: D-cycloserine (Drug)
Placebo (original version)
Placebo administered orally twice per day for 4 weeks.
干预措施: Placebo (Other)
D-cycloserine 50 mg
D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
干预措施: D-cycloserine (Drug)
D-cycloserine 250mg
This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
干预措施: D-cycloserine (Drug)
Placebo (revised version)
Placebo administered orally twice per day for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
时间窗: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
次要结局
- Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane(From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year))
- Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment(From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year))
- Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period(From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year))
- Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.(From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year))