Aromatherapy Oil Associated for Managing Anxiety and Pain During Bone Marrow Biopsy Procedures

NCT06581211 | Suspended DMC

• 3 other identifiers: 23234P30CA033572NCI-2024-05514
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial evaluates whether using aromatherapy can reduce pain and anxiety for cancer patients during routine biopsy procedures. Because of the discomfort associated with a bone marrow aspirate and biopsy (BMAB), many patients have significant anxiety in addition to their pain. With the current background of the opioid crisis, researchers have been looking for different ways to treat pain and anxiety in cancer patients without using medications that have a risk for abuse. Recent research suggests that using lavender aromatherapy may be an effective and more affordable treatment for anxiety and pain in patients. Information gathered from this study may help researchers determine whether using aromatherapy may help to manage pain and anxiety during biopsy procedures for cancer patients.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• Proportion of patients participated in the aromatherapy oils (Feasibility)

  Will consider the study feasible if \> 70% of patients are able to complete the oil treatment (lavender, linalool or placebo). Will be estimated within 95% confidence interval.

  Up to 1 month

• Proportion of patients completed the aromatherapy oils (Feasibility)

  Completion will be defined as receiving oil treatments as described. Each patient will be assigned one of the following categories: 1) complete treatment course, 2) incomplete treatment course, or 3) unknown (not assessable, insufficient data). Will be estimated within 95% confidence interval.

  Up to 1 month

• Patient satisfaction

  Will be evaluated using a survey, in order to fully understand their experience with the treatment. Will also evaluate whether the patients are interested in aromatherapy oils for future bone marrow aspiration and biopsy (BMAB), and their experience in the clinical trial. Descriptive analyses (exploratory) will be provided for all individual assessment items.

  One time patient satisfaction assessment within 30 minutes after bone marrow aspiration and biopsy (BMAB).

Secondary Outcomes (4)

• Association between aromatherapy and other symptoms

  The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours

• Association between aromatherapy and anxiety

  The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours

• Clinician's responses

  At post-BMAB up to 24 hours

• Association between aromatherapy and pain

  The 3 time points are: at baseline before oil administration; after oil administration before BMAB; after BMAB up to 24 hours

Study Arms (3)

Group I (LOA)

EXPERIMENTAL

Patients inhale LOA for 20 minutes prior to SOC BMAB and throughout the procedure.

Other: Electronic Health Record Review; Other: Lavender Oil; Other: Questionnaire Administration

Group II (LA)

EXPERIMENTAL

GROUP II: Patients inhale LA for 20 minutes prior to SOC BMAB and throughout the procedure.

Procedure: Aromatherapy and Essential Oils; Other: Electronic Health Record Review; Other: Questionnaire Administration

Group III (jojoba)

PLACEBO COMPARATOR

Patients inhale jojoba oil for 20 minutes prior to SOC BMAB.

Other: Electronic Health Record Review; Other: Jojoba Oil; Other: Questionnaire Administration

Interventions

Aromatherapy and Essential Oils PROCEDURE

Inhale LA

Also known as: Aromatherapy

Group II (LA)

Electronic Health Record Review OTHER

Ancillary studies

Group I (LOA); Group II (LA); Group III (jojoba)

Jojoba Oil OTHER

Inhale jojoba oil aromatherapy

Group III (jojoba)

Lavender Oil OTHER

Inhale LAO

Also known as: Common Lavender Oil, English Lavender Oil, Lavandula officinalis Flowering Top Oil

Group I (LOA)

Questionnaire Administration OTHER

Ancillary studies

Group I (LOA); Group II (LA); Group III (jojoba)

Eligibility Criteria

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

You may qualify if:

• Patients must have the ability to understand and sign a written informed consent document, and be willing to follow protocol requirements
• Ability to read and understand English for patient reported outcomes
• Age \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Willingness to comply with all study interventions of essential oil aromatherapy
• Anxiety \> 3 on a 0-10 visual analog scale regarding the bone marrow biopsy/aspirate procedure
• The study is open to all participants regardless of gender, race, or ethnicity

You may not qualify if:

• Allergy to lavender oil, linalool oil, jojoba oil
• Previous enrollment in this study
• Uncontrolled respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)
• Mental incapacitation (ex. stroke, brain metastasis etc.) that would cause inability to follow directions, in the opinion of the investigators
• Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use), as determined by the patient's primary cancer team.
• If a patient has a history of a psychiatric disorder, we will contact their primary cancer team to determine if their condition is controlled or uncontrolled, and if it will interfere with the study
• Recent changes in the past 2 weeks to medications prescribed for pain or anxiety
• Abnormal smelling abilities due to sinus infections, long COVID, etc.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope at Lennar

Irvine, California, 92618, United States

Location

MeSH Terms

Interventions

Aromatherapy; jojoba wax; lavender oil

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Richard T Lee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

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: July 16, 2024
• First Posted: September 3, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (2)