Phase 2 Completed N=92 Randomized Single-blind Supportive Care

Use of Aromatherapy to Reduce Symptom Burden

Anxiety · Chemotherapy-Induced Nausea and Vomiting

Source: ClinicalTrials.gov NCT05251337 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

May 2024

Primary outcomePrimary: Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours — 9.6; 8.5; 5.2; 4.9 score on a scale — p=0.462

Summary

The purpose of this study is to evaluate the effect of inhaled aromatherapy on symptoms of nausea/vomiting and anxiety in patients who have received a stem cell transplant. Aromatherapy involves essential oils from aromatic plants that can be absorbed into the body in different ways. Our study will be using inhaled aromatherapy, which has been found helpful for symptoms such as nausea/vomiting and anxiety.

Outcome Measures

Outcome	Result	p-value
PRIMARY Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours	9.6; 8.5; 5.2; 4.9; 3.9; 4.4	0.462
PRIMARY Anxiety Symptoms at Baseline 24 Hours, and 48 Hours	14.4; 15.4; 10.9; 13.3; 10.5; 12.9	0.285
SECONDARY Patient Satisfaction at 48 Hours	0; 0; 0; 0; 0; 0	—
SECONDARY Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe	10.0; 7.1	0.091
SECONDARY Inpatient Fall Events at Baseline and During Intervention	32; 31	—

Eligibility Criteria

Inclusion Criteria

Patients from a bone marrow transplant unit or hematology/oncology unit within an adult academic health center in the Midwest.
Adult stem cell transplant inpatients that have received autologous or allogeneic transplant and are actively going through therapy.
Patients must also be alert and oriented, able to interact with the study team, and able to read and write English.

Exclusion Criteria

Under 18 years of age
Intubation
Medical sedation
Receipt of chimeric antigen receptor T (CAR-T) cells
History of atrial fibrillation
History of seizures/epilepsy
Adhesive allergy or sensitivity
Currently pregnant
Prisoner

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05251337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.