Feasibility of Substitution of Volatile Organic Compound Humidification to Simulate the Forest Experience Effects on Immune System Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Humidified phytoncides to simulate the forest greenspace immersion (SFIT)
研究概览
简要总结
This clinical trial studies the feasibility of simulating forest therapy using humidified wood or fragrant oils, in improving immune cells, like natural killer cells, number and activity, and their downstream proteins, perforin and granulysin in patients with stage I-III breast or prostate cancer who completed chemo- and/or radiation therapy. The knowledge gained from this study may help cancer patients who have compromised immune systems and who also cannot participate in outdoor activities like exercise or forest walks.
详细描述
PRIMARY OBJECTIVE:
I. Determine the feasibility of using humidified phytoncides to simulate the forest greenspace immersion (simulated forest immersion therapy [SFIT]) in cancer patients with solid tumor who have completed surgery, chemo- and radiation therapy as an alternate method of access to the natural forest greenspace.
SECONDARY OBJECTIVE:
I. Determine the feasibility of collecting and analyzing immune system measures while deploying the simulated forest immersion therapy with forest oils (SFIT), as well as measuring natural killer (NK) cell number and activity, and perforin and granulysin.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Age >= 18 years. Both men and women and members of all races and ethnic groups will be included
- •Participants must have histologically or cytologically confirmed breast cancer or prostate cancer (hormone therapy excepted) who are in stage I-V with or without evidence of metastasis using the Cancer Therapy Evaluation Program (CTEP) Simplified Disease Classification
- •Participants must be within 12 months of their first diagnosis of breast or prostate cancer
- •Criteria for solid tumors: Participants must have measurable disease, per doctor of medicine (MD) and data in medical record
- •Participants must have no history of autoimmune disease
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •If they have asthma. Rationale: forest oils may be a possible trigger for asthma
- •If they have a known allergy to citrus peel or pine forests. Rationale: forest oils may cause contact dermatitis and coughing
- •If they are unable to detect common odors from commercial fragrances. Rationale, forest oils are humidified as an aroma to be inhaled in the simulate the forest greenspace immersion (SFIT)
- •First diagnosis of breast or prostate cancer is longer than 12 months ago. Rationale, NK cell number recovery may be complete by this time after first treatment
- •Febrile illness/infection within previous two weeks. Rationale, immune biomarkers will reflect previous febrile illness
- •Current tobacco or tobacco use within 1 hour of start of SFIT. Rationale: forest oils may cause contact dermatitis and coughing
- •Prior autoimmune disease, are on immune-modulating therapies (endocrine therapy allowed). Rationale, because of their poor prognosis rather than being in early stages of cancer
- •Had surgery or invasive procedure in the past two months. Rationale, because of their poor prognosis rather than being in early stages of cancer
- •Inability to complete study requisites
研究组 & 干预措施
Supportive care (SFIT, biospecimen, interview)
Patients participate in SFIT, using humidified wood and fragrance oils, over 1 hour. on day 1, day 3 or 4 and on day 7. Patients also undergo blood sample collection at baseline and on days 3 or 4 and 7 and participate in interviews at baseline and post-treatment.
干预措施: Aromatherapy with Essential Oils (Other)
结局指标
主要结局
Humidified phytoncides to simulate the forest greenspace immersion (SFIT)
时间窗: Baseline/Day 1
Feasibility analysis will include qualitative interview data blinded by participant, CRC/research assistant and principal investigator. Qualitative interview questions include ease of use/deployment of humidified forest oils by the CRC/research assistant and PI, the ability of the participants to tolerate SFIT. The responses will be coded, themed and summarized will be used to determine the feasibility of intervention deployment and creation of a standardized procedure for future research. To determine dose drop off between the start of SFIT and the end of SFIT of the humidified phytoncides a t-test with an alpha level of 0.05 will be used.
次要结局
- Collecting and analyzing immune system measures while deploying the simulated forest immersion therapy with forest oils(Baseline and at day 3 or 4 and on Day 7)
研究者
Amy M. Ross Ph.D.
Principal Investigator
OHSU Knight Cancer Institute