Aromatherapy Inhaler Use for HSCT Distress

Stanford University

Status: Enrolling

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

Treatments: Other: Aromatherapy Inhaler

Study type: Interventional

Funder types: Other

Identifiers

NCT05302583

IRB-65140

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

SOC only then SOC plus Aromatherapy Inhaler

Other group

Description:

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.

Treatment:

Other: Aromatherapy Inhaler

SOC and Aromatherapy Inhaler then SOC only

Other group

Description:

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.

Treatment:

Other: Aromatherapy Inhaler