Aromatherapy Inhaler Use for HSCT Distress

NCT ID: NCT05302583

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2026-03-31

Brief Summary

The purpose of this research is to evaluate aromatherapy inhaler use and how it may impact cancer distress and coping by patients in the first few days after hematopoietic stem cell transplant (HSCT).

Detailed Description

Phase 1: Transplant Day +1, +2, or +3. Phase 2: Washout Day: Standard of care (SOC) pharmacological intervention only. Phase 3: Transplant Day +3, +4, or +5). Study Completion: Transplant Day +4, +5, or +6.

*Study activities will occur on a single day for each phase. However, a three-day window for Phases 1 and 3 will allow consideration of patients' ability to participate in the immediate post-transplant period.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

SOC only then SOC plus Aromatherapy Inhaler

1. Participant will receive standard of care pharmacological intervention (SOC) as needed throughout the day.

2. Participants will complete the Standard of Care Pharmacological Intervention Use Log.

3. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.

Group Type: OTHER

Aromatherapy Inhaler

Intervention Type: OTHER

Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler

SOC and Aromatherapy Inhaler then SOC only

1. Participant will use the aromatherapy inhaler as needed for up to two (2) hours in the morning and complete the Aromatherapy Inhaler Use Log.

2. At between 1300 and 1500 hours, study personnel will administer the NCCN Distress Thermometer and Problem List.

Group Type: OTHER

Aromatherapy Inhaler

Intervention Type: OTHER

Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler

Interventions

Aromatherapy Inhaler

Lavender Aromatherapy Inhaler Peppermint Aromatherapy Inhaler

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Oh, PhD, MPH, RN

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aubrey Florom-Smith, PhD, RN

Role: CONTACT

aubsmith@stanford.edu

650-285-9512

Facility Contacts

Aubrey L Florom-smith, PhD, RN

Role: primary

afloromsmith@stanfordhealthcare.org

650-285-9512

Other Identifiers

IRB-65140

Identifier Type: -

Identifier Source: org_study_id