This randomized, blinded clinical trial assessed the feasibility and preliminary benefit of aromatherapy for managing symptoms during chemotherapy. The study used a four-arm design with inhalation aromatherapy assigned to participants in one of four scent arms: lavender, jojoba, orange, or ginger. Enrolled participants received a baseline cycle without aromatherapy, followed by Cycle 2 with aromatherapy; an optional third cycle was available.
The primary objective was feasibility, operationalized as participant retention and aromatherapy compliance through Cycle 2. Secondary, preliminary efficacy outcomes were evaluated using a composite symptom severity metric derived from daily symptom ratings.
Ninety-one cancer patients aged 8 years and older were randomized across the four inhaler arms. Of those randomized, 84 participants initiated the baseline (no aromatherapy) cycle. The trial compared within-participant symptom ratings between the baseline cycle and Cycle 2 when aromatherapy inhalers were used.
Assigned inhaler scents were specifically lavender, jojoba, orange, and ginger. Randomization and blinding procedures were implemented, as described in the trial report, to allocate participants to one of these four arms.
Participants were instructed to use their assigned aromatherapy inhaler at least four times per day for seven consecutive days during each cycle. Daily symptom assessment covered seven predefined symptoms: nausea, vomiting, pain, anxiety, fatigue, sleep difficulties, and lack of appetite. Each symptom was rated on a numeric scale from 0 to 10 and recorded daily for the seven-day period of each cycle.
The study calculated a composite symptom severity score (CSSS) by summing the daily scores for all seven symptoms over the seven-day assessment window for each cycle. This CSSS served as the primary quantitative measure for preliminary efficacy comparisons between baseline and aromatherapy cycles.
Feasibility benchmarks were met in this trial. Of the 84 participants who started the baseline cycle, 68 completed through Cycle 2, corresponding to an overall retention rate of 81.0% (68/84). Adherence and acceptability were high: 83.3% of all participants reported using their inhaler at least 21 times during Cycle 2, surpassing the predefined target adherence threshold of ≥75%.
These results indicate that inhalation aromatherapy delivered via portable inhalers is practical for use in the chemotherapy setting and is acceptable to a majority of participants in this trial.
Preliminary efficacy was evaluated by comparing mean CSSS between Cycle 2 (aromatherapy) and the baseline cycle (no aromatherapy). The overall change in mean CSSS between Cycle 2 and baseline was −1.38, with a standard error of 0.54, indicating a reduction in composite symptom severity associated with aromatherapy use in this sample.
The trial report frames this change as preliminary evidence of symptom reduction but notes that further research is required to validate the effect size, determine clinical significance for individual symptoms, and explore potential differences across scent arms.
The clinical trial was approved by the University of Rochester Medical Center Research Subjects Review Board (RSRB, STUDY00001639) and conducted in accordance with the Declaration of Helsinki. The trial received an Investigational New Drug (IND) exemption from the U.S. Food & Drug Administration and was registered on ClinicalTrials.gov (NCT03449511). Informed consent was obtained from all participants. The authors declared no relevant financial or non-financial competing interests.
The investigators conclude that inhalation aromatherapy is a feasible and acceptable non-pharmacologic integrative modality for chemotherapy-related symptom management based on retention and adherence outcomes and a modest reduction in composite symptom severity (mean CSSS change −1.38, SE = 0.54).
The report emphasizes that these findings are preliminary. The authors recommend further studies to replicate and validate efficacy outcomes, to assess clinical significance for specific symptoms, and to investigate underlying mechanisms by which aromatherapy may influence symptom experience during chemotherapy.