Humidified Forest Oils for Immune System Recovery in Stage I-III Breast or Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Patients participate in SFIT, using humidified wood and fragrance oils, over 1 hour. Patients also undergo blood sample collection at baseline and on day 3 or 4 and participate in interviews at baseline and post-treatment.

Official Title
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Feasibility of Substitution of Volatile Organic Compound Humidification to Simulate the Forest Experience Effects on Immune System Recovery

Conditions
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Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Malignant Solid Neoplasm, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8

Intervention / Treatment
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* Other: Aromatherapy with Essential Oils


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 hormone receptor positive (HR+) HER2 negative (-) breast cancer or prostate cancer (hormone therapy excepted) who are in Stage I-III 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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (SFIT, biospecimen, interview)<br>Patients participate in SFIT, using humidified wood and fragrance oils, over 1 hour. Patients also undergo blood sample collection at baseline and on day 3 or 4 and participate in interviews at baseline and post-treatment. | Other: Aromatherapy with Essential Oils<br>* Participate in SFIT this is one intervention with aroma therapy with essential Forest oils<br>* Other names: Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humidified phytoncides to simulate the forest greenspace immersion (SFIT) | 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. | Baseline/Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collecting and analyzing immune system measures while deploying the simulated forest immersion therapy with forest oils | Will measure natural killer (NK) cell number and activity, and perforin and granulysin. NK cell number (NK CD3-/CD56+/) and activity (NK CD3-/CD56+/CD69+) will be tested with Flow Cytology. Perforin and granulysin will be tested by ELISA. Will use a t-test to determine the differences between these 4 variables collected at baseline and a Day 3-4. An alpha level of 0.05 will be set. Alternate analysis, the change NK cell number and activity will be determined from the mean of the standard range. | Baseline and at day 3 or 4 |