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

NCT05012813 | Completed

• 2 other identifiers: STUDY00023183NCI-2021-08489
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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- 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.

Conditions

Breast Carcinoma; Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

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.

Other: Aromatherapy with Essential Oils

Interventions

Aromatherapy with Essential Oils OTHER

Participate in SFIT this is one intervention with aroma therapy with essential Forest oils

Also known as: Therapeutic Interventions, Therapeutic Method, Therapeutic Procedure, Therapeutic Technique, Therapy

Supportive care (SFIT, biospecimen, interview)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms

Interventions

Aromatherapy; Oils, Volatile; Coal Tar; Therapeutics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Oils; Lipids; Tars; Complex Mixtures

Study Officials

• Amy M Ross, Ph.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 19, 2021
• Study Start: July 19, 2022
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)