Virtual Reality Greenspace and Humidified Forest Oils on Immune System Recovery in Stage I-III Breast or Prostate Cancer

Sponsor
OHSU Knight Cancer Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05012813
Collaborator
Oregon Health and Science University (Other)
25
Enrollment
1
Location
1
Arm
11.1
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies the feasibility of simulating forest immersion via virtual reality, paired with 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

PRIMARY OBJECTIVE:
  1. Determine the feasibility of using virtual reality (VR) paired with 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:
  1. 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 VR pictures of forest and greenspace, and 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Feasibility of Substitution of Virtual Reality Greenspace and Volatile Organic Compound Humidification to Simulate the Forest Experience Effects on Immune System Recovery
Anticipated Study Start Date :
Feb 28, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Supportive care (SFIT, biospecimen, interview)

Patients participate in SFIT, using VR pictures of forest and greenspace, and 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 and Virtual Reality
Participate in SFIT this is one intervention with Virtual Reality (VR) and aroma therapy with essential Forest oils
Other Names:
  • Aromatherapy with Essential Oils
  • Virtual Reality
  • Therapeutic Interventions
  • Therapeutic Method
  • Therapeutic Procedure
  • Therapeutic Technique
  • Therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Virtual reality paired with humidified phytoncides to simulate the forest greenspace immersion (SFIT) [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 VR and 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.

    Secondary Outcome Measures

    1. Collecting and analyzing immune system measures while deploying the simulated forest immersion therapy with forest oils [Baseline and at day 3 or 4]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 no evidence of metastasis using the Cancer Therapy Evaluation Program (CTEP) Simplified Disease Classification

    • Criteria for solid tumors: Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam

    • 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)

    • If they have known metastases should be excluded from this clinical study. Rationale, because of their poor prognosis rather than being in early stages of cancer

    • 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1OHSU Knight Cancer InstitutePortlandOregonUnited States97239

    Sponsors and Collaborators

    • OHSU Knight Cancer Institute
    • Oregon Health and Science University

    Investigators

    • Principal Investigator: Amy M Ross, Ph.D., OHSU Knight Cancer Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amy M. Ross Ph.D., Principal Investigator, OHSU Knight Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT05012813
    Other Study ID Numbers:
    • STUDY00023183
    • NCI-2021-08489
    • STUDY00023183
    First Posted:
    Aug 19, 2021
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2022