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Recruiting NCT05302583

Aromatherapy Inhaler Use for HSCT Distress

No phase Interventional Cancer Distress Cancer Coping Hematopoetic Stem Cell Transplant Aromatherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aromatherapy Stick, Standard of Care.
Who it may be relevant to
Registry conditions: Cancer Distress, Cancer Coping, Hematopoetic Stem Cell Transplant, Aromatherapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Aromatherapy Inhaler Use for Hematopoietic Stem Cell Transplant Patient Distress

Overview

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.

Detailed description

Patients undergoing hematopoietic cell transplantation (HCT) commonly experience high levels of distress and other symptoms during the acute inpatient period. Inhaled aromatherapy is a low-burden, patient-directed supportive care strategy that may be feasible to deliver during hospitalization. This randomized, parallel-group study will evaluate the feasibility and acceptability of an aromatherapy inhaler ("aromatherapy stick") during the early post-transplant inpatient period and will explore short-term changes in patient-reported outcomes.

Interventions

  • Other Aromatherapy Stick
    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.
  • Other Standard of Care
    Participants receive standard inpatient supportive care during the acute post-HCT period. No aromatherapy inhaler is provided.

Primary outcome measures

  • Change in cancer distress (NCCN Distress Thermometer) [Time frame: Baseline: SOC/Inhaler Use Day (Transplant Day +1, +2, or +3); Follow-up: Study Completion Day (Transplant Day +2, +3, or +4)]
Secondary outcome measures (3)
  • Change in cancer coping self-efficacy (Cancer Behavior Inventory-Brief Form, modified) [Time frame: 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) [Time frame: 1 day (Inhaler Use Day)]
  • Aromatherapy experience (Final Evaluation of Aromatherapy) [Time frame: Study Completion Day (Transplant Day +4, +5, or +6)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT05302583 · IRB-65140 · NCI-2026-02783

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗