The Role of Transient Receptor Potential Channels in Chemotherapy-Induced Peripheral Neuropathic Pain.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Inter-hand reproducibility cinnamaldehyde
研究概览
简要总结
Part I:
Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in healthy, male volunteers. In addition, the inter-period and inter-hand reproducibility of the increase in dermal blood flow will be assessed.
Part II:
Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in patients suffering from chemotherapy-induced peripheral neuropathy compared to matched healthy volunteers.
Part III:
Evaluating the increase in dermal blood flow upon topical application of cinnamaldehyde and capsaicin on the fingers in patients who are treated with paclitaxel or oxaliplatin.
详细描述
The primary aim is to investigate whether paclitaxel and/or oxaliplatin alter TRP channel functionality in vivo in human. TRP functionality can indirectly be assessed via dermal blood flow changes which are part of the so-called neurogenic inflammation, induced upon TRP activation. In vivo in human, TRP can be activated via topical application of cinnamaldehyde or capsaicin on the skin.
In Part I of the study, the DBF changes upon topical application of cinnamaldehyde or capsaicin on the fingers will be characterized, including inter-period and inter-hand reproducibility.
In Part II, patients who are suffering from chronic CIPN after treatment with paclitaxel or oxaliplatin are included. DBF changes upon cinnamaldehyde and capsaicin are compared to a matched control group.
In Part III, DBF changes are assessed in patients prior to the first administration of taxol/oxaliplatin and at regular points in time during the dosage regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Subject has eczema, scleroderma, psoriasis, dermatitis, or keloids, tumors, ulcers, burns, flaps or grafts on their fingers or any other abnormality of the skin which, in the opinion of the investigator may interfere with the study assessments.
- •Subject has excessive hair growth on the fingers.
- •Subject cannot avoid excessive tanning (any exposure to sunlight or a tanning bed which would cause a sunburn reaction) throughout the study.
- •Subject has a history of significant severe (drug) allergies.
- •Subject uses any prescription or non-prescription drugs on a regular basis which, in the investigator's opinion, might confound the results of the study.
- •Subject currently uses lotions, oils, depilatory preparations, makeup, or other topical treatments on the fingers on a regular basis which cannot be discontinued for the duration of the study.
- •Subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a regular user of any illicit drugs, or has a history of drug (including alcohol) abuse.
- •Subject is unable to refrain from drinking caffeinated beverages (e.g. coffee, tea, cola, ...) 24 hours prior to each study visit. Subject is unable to limit their intake of caffeinated beverages to ≤4 cups a day throughout the study.
- •Subject has any of the following vital sign measurements at screening after at least 10 minutes of supine rest: Heart Rate <40 or >100 beats/min, Diastolic Blood Pressure <50 or >90 mmHg, Systolic Blood Pressure <90 or >140 mmHg.
- •Subject is currently participating or has been involved in testing an investigational drug in another clinical study within the last 4 weeks.
- •Subject is in a situation or has a condition which, in the opinion of the investigator, may interfere with safe and optimal participation in the study.
- •Subject has a history of any illness or disorder which, in the investigator's opinion, might confound the results of the study.
- •Subject suffered from peripheral neuropathy prior to the chemotherapeutic treatment (Only for patients).
- •Subject has (a history of) diabetes mellitus, amyloidosis, vitamin B deficiency or any other medical disorder that, in the investigator's opinion, may cause peripheral neuropathy (only for Part II and III).
- •Subject has (a history of) a lesion in the central nervous system that is known to possibly cause neuropathic pain: e.g. spinal cord injury, infarction localized in the brainstem or thalamus, syringomyelia, multiple sclerosis, or any other disorder of the CNS that, in the investigator's opinion, may cause neuropathic pain (only for Part II and III).
- •Subject has a history of treatment with bortezomib, vincristine, or any other compound that, in the investigator's opinion, may cause neuropathic pain (only for Part II and III).
- •Subject did not develop neuropathy after treatment with epirubicine-cyclofosfamide (only for the paclitaxel group in Part III).
- •Subject has a family history of peripheral neuropathy (only for Part II and III).
研究组 & 干预措施
Healthy volunteers
Young, healthy male volunteers to characterize the DBF changes upon cinnamaldehyde and capsaicin, including the reproducibility.
干预措施: Cinnamaldehyde and capsaicin (Other)
Paclitaxel Patients
Group of patients after treatment with paclitaxel.
干预措施: Cinnamaldehyde and capsaicin (Other)
Paclitaxel Controls
Group of healthy volunteers, matched for sex, age and BMI with the group of Paclitaxel Patients.
干预措施: Cinnamaldehyde and capsaicin (Other)
Oxaliplatin Patients
Group of patients after treatment with oxaliplatin.
干预措施: Cinnamaldehyde and capsaicin (Other)
Oxaliplatin Controls
Group of healthy volunteers, matched for sex, age and BMI with the group of Oxaliplatin Patients.
干预措施: Cinnamaldehyde and capsaicin (Other)
Longitudinal Paclitaxel Patients
Group of patients who are treated with paclitaxel.
干预措施: Cinnamaldehyde and capsaicin (Other)
Longitudinal Oxaliplatin Patients
Group of patients who are treated with oxaliplatin.
干预措施: Cinnamaldehyde and capsaicin (Other)
结局指标
主要结局
Inter-hand reproducibility cinnamaldehyde
时间窗: Dermal blood flow response measured simultaneously on both hands during 60 minutes post-application during study visit 1
The within subject inter-hand reproducibility of the dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers
DBF in patients before, during and after chemotherapeutic treatment
时间窗: Dermal blood flow measured prior to the first, or within 5 days after administration of paclitaxel or oxaliplatin
The dermal blood flow changes upon topical application of cinnamaldehyde and capsaicin in patients prior to, during and after treatment with either paclitaxel or oxaliplatin.
Inter-hand reproducibility capsaicin
时间窗: Dermal blood flow response measured simultaneously on both hands during 60 minutes post-application during study visit 3
The within subject inter-hand reproducibility of the dermal blood flow response to topical application of capsaicin as assessed by LASCA on the fingers in healthy, male volunteers.
Inter-period reproducibility capsaicin
时间窗: Interval of at least 5 days between both periods
The within subject inter-period reproducibility (i.e. assessing changes) of the dermal blood flow response to topical application of capsaicin as assessed by LASCA on the fingers in healthy, male volunteers.
Inter-period reproducibility cinnamaldehyde
时间窗: Interval of at least 5 days between both periods
The within subject inter-period reproducibility (i.e. assessing changes) of the dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers
Characterization cinnamaldehyde
时间窗: Dermal blood flow response measured during 60 minutes post-application
The dermal blood flow response to topical application of cinnamaldehyde as assessed by LASCA on the fingers in healthy, male volunteers.
Characterization capsaicin
时间窗: Dermal blood flow response measured during 60 minutes post-application
The dermal blood flow response to topical application of capsaicin as assessed by LASCA on the fingers in healthy, male volunteers
DBF patients compared to healthy volunteers
时间窗: Dermal blood flow measured in patients who are suffering from CIPN 1 to 12 months after the last administration of paclitaxel or oxaliplatin.
The dermal blood flow changes upon topical application of cinnamaldehyde and capsaicin in patients suffering from chemotherapy-induced peripheral neuropathy compared to matched healthy volunteers.
次要结局
未报告次要终点