Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
研究概览
简要总结
This study will evaluate an oil blend with active ingredients for the reduction in chemotherapy-induced peripheral neuropathy in people with breast cancer. Half of the participants will receive the oil blend with active ingredients and the other half will receive a placebo (an oil blend with no active ingredients). One-fourth of the people will also take pictures of their life with chemotherapy-induced peripheral neuropathy.
详细描述
Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, debilitating consequence of cancer treatment and is considered the most adverse of non-hematologic events. Current pharmacological approaches to reduce CIPN symptoms can be ineffective and cause adverse effects.
Constituents of this oil blend moderate pain signal transmission through non-competing inhibition of 5-HT, AchE, and Substance P, along with antagonism of TRPA1 and TRPV1. This study will test the hypothesis that an oil blend reduces CIPN symptoms and improves quality-of-life (QOL) in breast cancer patients. The Human Response to Illness model is used to underpin a convergent-nested-parallel mixed-methods design with intervention.
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
- Single (Participant)
盲法说明
Participants will be seen in two separate clinic rooms. Intervention and placebo will have identical packaging and labeling with the addition of an A or B.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of breast cancer
- •chronic CIPN symptoms in one or both lower extremities
- •three months or greater since last chemotherapy treatment
- •mean SF-MPQ-2 score of greater than or equal to three
- •a prognosis of greater than six months
排除标准
- •non-English-speaking
- •blindness
- •pregnancy
- •breastfeeding
- •allergy to EOI or Peru balsam (cross-allergen)
- •illegal substance usage
- •history of severe skin reactions
- •non-intact skin on lower extremities
- •history of lower extremity trauma or amputation
- •current use of aromatherapy/Essential Oils
- •asthma or reactive airway disease triggered by constituents of EOI
- •history of mental illness or chronic depression
- •the following co-morbidities: G6PD deficiency, inherited peripheral neuropathy, active herpes varicella-zoster, herpes simplex virus, alcoholic neuropathy, repetitive stress or entrapment neuropathy, peripheral vascular disease, and multifocal mononeuropathy.
结局指标
主要结局
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
时间窗: baseline and weekly for 6 weeks
A 22-item self-report pain intensity (over past week) peripheral neuropathy questionnaire. Each item is scored from 0 -10 (0 is no pain and 10 is the worst possible pain), a mean score is obtained, yielding a mean score between 0 and 10.
次要结局
- Visual Analogue Scale - Pain (VAS)(Baseline and daily for 6 weeks)
- Quality of Life Adult Cancer survivor (QLACS)(Baseline, week four and week seven)
- Quality of Life: Chemotherapy-Induced Peripheral Neuropathy-20 (QOL:CIPN20)(Baseline, week four and week seven)