Breast CarcinomaNCT05012813
Humidified Forest Oils for Immune System Recovery in Stage I-III Breast or Prostate Cancer
A study testing Aromatherapy with Essential Oils in people with Breast Carcinoma and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Prostate Carcinoma
- What is being tested?
- Aromatherapy with Essential Oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Feasibility of Substitution of Volatile Organic Compound Humidification to Simulate the Forest Experience Effects on Immune System Recovery
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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 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.
- Conditions
- Breast Carcinoma, Prostate Carcinoma
- Being tested
- Aromatherapy with Essential Oils
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy with Essential OilsOther
Also called Therapeutic Interventions, Therapeutic Method, Therapeutic Procedure, Therapeutic Technique
Participate in SFIT this is one intervention with aroma therapy with essential Forest oils
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (SFIT, biospecimen, interview) | Experimental | 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. Receives: Other: Aromatherapy with Essential Oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline/Day 1
Secondary outcomes (1)
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.
Measured: Baseline and at day 3 or 4 and on Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start19 Jul 2022
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Amy M. Ross Ph.D., OHSU Knight Cancer Institute
- Investigators
- Amy M Ross, Ph.D., Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012813
- Sponsor's protocol ID
- STUDY00023183
- Other IDs
- NCI-2021-08489, STUDY00023183
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Substitution of Volatile Organic Compound Humidification to Simulate the Forest Experience Effects on Immune System Recovery
- ClinicalTrials.gov ID
- NCT05012813
- Acronym / sponsor ID
- STUDY00023183
- Conditions
- Breast Carcinoma, Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVE:
- 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:
- 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (SFIT, biospecimen, interview) | Experimental | Other: Aromatherapy with Essential OilsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy with Essential OilsAlso: Therapeutic Interventions, Therapeutic Method, Therapeutic Procedure, Therapeutic TechniqueParticipate in SFIT this is one intervention with aroma therapy with essential Forest oils | Other | Supportive care (SFIT, biospecimen, interview) |
Primary outcome
Humidified phytoncides to simulate the forest greenspace immersion (SFIT)
Time frame: 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.
1 secondary outcome
Collecting and analyzing immune system measures while deploying the simulated forest immersion therapy with forest oils
Time frame: Baseline and at day 3 or 4 and on Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy M Ross, Ph.D. principal investigator
OHSU Knight Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy with Essential Oils in people with Breast Carcinoma and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humidified phytoncides to simulate the forest greenspace immersion (SFIT) (time frame: Baseline/Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.