CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 112 enrolled
Drug / intervention
Inhalation of essential oilsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03585218
NCT03585218N/ACompleted

Clinical, Emotional, Cognitive and Neuropsychophysiological Impact of a Hedonic Aroma in Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life.

University of Minho·interventional·Posted Jul 12, 2018·Updated Aug 5, 2021

In Brief

A clinical study evaluating Inhalation of essential oils for Breast Cancer Female. Completed, enrolled 112 participants across 1 site.

Detailed Summary

Breast cancer is a major public health problem and is the main cancer disease in women worldwide and in Europe. In Portugal it is the most common cancer, the third cause of cancer death, following the European trend. Breast cancer (BC) triggers a myriad of physical and psychosocial stressors with repercussions on quality of life (QoL). This study is a pioneering Randomized Controlled Trial (RCT) in Portugal, which seeks to study the impact of a hedonic aroma during chemotherapy on women with breast cancer (3, 6 and 9 weeks, and 3 months after completion of chemotherapy). To this end, participants will be randomly assigned to one of the groups. The experimental group (EG) will be exposed to chemotherapy together with a hedonic aroma, while the control group (CG) will only be exposed to chemotherapy. Both groups will be assessed on psychological morbidity, illness perception, self-efficacy for coping, executive function, cortisol levels, side-effects, beliefs about chemotherapy and QoL. The aim of this study is to assess the impact of a hedonic aroma on the clinical, emotional and neurocognitive variables that contribute to reducing the side effects of chemotherapy and promoting QoL in women with BC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 12, 2018
Enrollment StartMar 6, 2017
Primary CompletionApr 4, 2019
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.0 years ago

Interventions

Inhalation of essential oilsbiological

Intervention "Inhalation of essential oils": From the T1 (2nd Cycle CT), Experimental Group Arms will undergo the inhalation of the hedonic aroma selected by them at the time of chemotherapy (among several types of aromas). It is intended that the participant, when receiving the CT, inhales the aroma phase-in and under the investigator's observation until the end of the treatment (about two hours). The inhalation of essential oils will occur using cotton rolls impregnated with the selected oil. The control group is not subject to intervention during chemotherapy treatment.