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Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life

NCT03585218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-08-05

No results posted yet for this study

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.

Conditions

  • Breast Cancer Female

Interventions

BIOLOGICAL

Inhalation of essential oils

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.

Sponsors & Collaborators

  • Foundation for Science and Technology, Portugal

    collaborator OTHER

  • University of Minho

    lead OTHER

Principal Investigators

  • Marta Pereira, Master · University of Minho

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2019-04-04
Completion
2019-04-04

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585218 on ClinicalTrials.gov