Aromatherapy Inhaler Use for HSCT Distress

NCT05302583 | Recruiting

• 2 other identifiers: IRB-65140NCI-2026-02783
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will evaluate the feasibility and acceptability of an inhaled aromatherapy stick for patients during the acute inpatient phase after hematopoietic cell transplantation (HCT) . The study will also explore whether aromatherapy use is associated with short-term changes in patient-reported cancer-related distress and coping self-efficacy.

Conditions

Cancer Distress; Cancer Coping; Hematopoetic Stem Cell Transplant; Aromatherapy

Outcome Measures

Primary Outcomes (1)

• Change in cancer distress (NCCN Distress Thermometer)

  Change in NCCN Distress Thermometer score (0-10 visual analog scale). Calculated as follow-up score minus baseline score.

  Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)

Secondary Outcomes (3)

• Change in cancer coping self-efficacy (Cancer Behavior Inventory-Brief Form, modified)

  Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)

• Aromatherapy Inhaler Use Log (Inhaler Use Log)

  1 day (Inhaler Use Day)

• Aromatherapy experience (Final Evaluation of Aromatherapy)

  Study Completion Day (Transplant Day +4, +5, or +6)

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants receive standard supportive care during hospitalization. No aromatherapy stick is provided.

Other: Standard of Care

Aromatherapy + Usual Care

EXPERIMENTAL

Participants receive standard supportive care plus aromatherapy inhaler education and an aromatherapy stick for self-administered inhalation. Aromatherapy use occurs on the assigned Inhaler Use Day (targeted for Transplant Day +1, +2, or +3). Use is tracked with an inhaler use log. The aromatherapy "dose" is standardized by a maximum total exposure time (up to 2 hours total), while allowing participants to choose how to distribute use.

Other: Aromatherapy Stick

Interventions

Aromatherapy Stick OTHER

Participants receive aromatherapy inhaler education and an aromatherapy stick for self-administered inhalation during the early post-transplant inpatient period. Aromatherapy use occurs on the assigned Inhaler Use Day (targeted for Transplant Day +1, +2, or +3) and is documented using an inhaler use log. Total exposure is limited to a maximum of 2 hours.

Aromatherapy + Usual Care

Standard of Care OTHER

Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided.

Usual Care

Eligibility Criteria

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

You may qualify if:

• Autologous and Allogeneic patients admitted to E1 for planned HSCT
• Patients with hematologic malignancies requiring HSCT
• No allergies to lavender or peppermint essential oils
• Must have received chemotherapy during preparative regimen (single or multi-agent regimen)
• Adult patient over 18 years of age
• Able to speak, read, and comprehend English
• Willing and capable of providing informed consent

You may not qualify if:

• Patients admitted for Chimeric Antigen Receptor T cell (CART) infusion
• Patients receiving a transplant for a germ cell tumor diagnosis
• Unexpected/unplanned admission (e.g., neutropenic fever, confusion, clinical deterioration)
• Immune effector cell-associated neurotoxicity syndrome (ICANS) grade 1 through 4
• History of scleroderma
• History of atrial fibrillation
• Known history of G6PD deficiency
• Allergic to lavender or peppermint essential oils
• Pediatric patient 18 years of age or less
• Unable to speak, read, and comprehend English
• Unwilling or incapable of providing informed consent

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anna Oh, PhD, MPH, RN

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Oh, PhD, MPH, RN

CONTACT

650-512-6691; aoh2@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: June 16, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)