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Trial record 63 of 238 for:    essential oil

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

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ClinicalTrials.gov Identifier: NCT03585218
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Marta Alexandra Marques Pereira, University of Minho

Brief Summary:
Breast cancer (BC) triggers a myriad of physical and psychosocial stressors with repercussions on quality of life (QoL). The present study is a pioneering Randomized Controlled Trial (RCT) in Portugal, seeking to study the impact of a hedonic aroma during chemotherapy in women with breast cancer (3, 6 and 9 weeks, and 3 months upon concluding chemotherapy). To do this, the participants will be randomly assigned to one of the groups. The experimental group will be exposed to chemotherapy along with a hedonic scent, while the control group will only be exposed to chemotherapy. Both groups will be evaluated at the level of psychological morbidity, disease representation, coping, executive function, cortisol levels, severity of treatment effects and QoL.The aim of this study is to evaluate the impact of a hedonic aroma on the clinical, emotional and neurocognitive variables that contribute to reduce the side effects of chemotherapy and promote QoL in women with BC.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Biological: Inhalation of essential oils Phase 3

Detailed Description:

The sample was non-probabilistic, consisting of 51 participants in the control group (CG) and 51 in the experimental group (EG), necessary to detect a difference of 10 points between the groups (standard deviation = 18), in EORCT QLQ- C30, for a power of 80% and a significant level of 5%.

Five moments of evaluation: T0 (baseline: oncology consultation before AQ), T1 (3 weeks after QT onset - 2nd Cycle), T2 (6 weeks - 3rd Cycle), T3 (9 weeks - 4th Cycle) and T4 (3 months upon concluding QT) (Annex 3 - Flowchart). These moments were chosen taking into account the classes of drugs used in AQ. Each cycle has an interregnum of 21 or 14 days, depending on the AQ protocol used. Randomized and controlled clinical study (RCT), single blind (the participant does not know to which group belongs, only the investigator) and longitudinal.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: On each moment of data collection, the researcher will apply the evaluation protocol to the participant regardless of the group. Regarding the psychophysiological variable, each participant's saliva will be collected using salivettes®, while cortisol concentrations will be analyzed through ELISA kits. At baseline, each participant will be provided with three salivettes and an explanatory leaflet so that, on the day before the 2nd Cycle (T1), they can collect their own saliva, around 23 hours before (lowest peak of the cortisol circle), and on the day of the fasting QT, on waking up and thirty minutes after waking up (highest peak of the cortisol circle and assessing reactivity). This process will be replicated throughout the remaining evaluation moments. Subsequently, it is also our goal to evaluate the cortisol levels due to QT by performing one collection of saliva before QT and another thirty minutes after QT.
Masking: Single (Participant)
Masking Description: When a participant is eligible, according to the inclusion criteria, it is allocated to one of the groups, according to the order of entry in the study and with alternation by groups, in a ratio of 1:1.
Primary Purpose: Prevention
Official Title: Clinical, Emotional, Cognitive and Neuropsychophysiological Impact of a Hedonic Aroma in Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life.
Actual Study Start Date : March 6, 2017
Actual Primary Completion Date : April 4, 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Experimental Group
The Experimental Group participants will be submitted to the inhalation of the hedonic aroma during the chemotherapeutic treatment, this being the intervention of the study.The control group is not subject to intervention.
Biological: Inhalation of essential oils
Intervention "Inhalation of essential oils": From the T1 (2nd Cycle QT), 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 QT, 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.

No Intervention: Control Group
The control group is not subject to intervention.



Primary Outcome Measures :
  1. Anxiety and depression [ Time Frame: Change in baseline Anxiety and Depression in the 4th cycle of chemotherapy (Time 3 - 63 days after the start of chemotherapy) and follow up (Time 4 - 3 months after chemotherapy ends) ]
    assessment instruments: Hospital Anxiety and Depression Scale (HADS)

  2. Distress [ Time Frame: Change in baseline Distress in the 4th cycle of chemotherapy (Time 3 - 63 days after the start of chemotherapy) and follow up (Time 4 - 3 months after chemotherapy ends) ]
    Emotions Thermometer

  3. The experimental group presented, in comparison to the control group, lower blood pressure [ Time Frame: Change in the experimental group in the blood pressure of the 1st cycle (each cycle occurs every 21 days) compared to the other cycles of chemotherapy where they inhale the essential oils: up to 63 days. ]
    blood pressure measurement

  4. The experimental group presented, in comparison to the control group, lower level of cortisol concentration [ Time Frame: Change in the experimental group in the blood pressure of the 1st cycle (each cycle occurs every 21 days) compared to the other cycles of chemotherapy where they inhale the essential oils: up to 63 days. ]
    saliva collection and biochemical analysis of cortisol through ELISA kits

  5. The experimental group presented, in comparison to the control group, lower level of side effects [ Time Frame: Change in baseline QLQ BR23 baseline scores for follow up (3 months after completion of chemotherapy treatment) in the experimental group. ]
    assessment instruments: the EORTC QLQ-BR23 (European Organisation for Research and Treatment of Cancer - Quality of Life, Module for Breast Cancer). interpretation of the results, the higher the value obtained, lower the quality of life, except in questions 14, 15 and 16 where: the higher the score, the better the quality of life evaluated

  6. The experimental group presented, in comparison to the control group, lower level of quality of life [ Time Frame: Change in baseline QLQ C30 baseline scores for follow up (3 months after completion of chemotherapy treatment) in the experimental group. ]
    Assessment instruments: the European Organisation for Research and Treatment of Cancer - Quality of Life (EORTC QLQ-C30). Interpretation of the results, the higher the value obtained, the better the total quality of life - total quality of life result, through weighting formulas carried out by the European Organization for Research and Treatment of Cancer (EORTC) (http://groups.eortc.be/qol/manuals)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with BC in stages 0-2;
  • level 0-2 on the Zubrod scale,
  • without cognitive impairment,
  • adjuvant chemotherapy (AQ) treatment.

Exclusion Criteria:

  • Severe mental disturbance;
  • olfactory impairment (≤6), evaluated at baseline through the instrument smell diskettes and only in the EG participants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585218


Contacts
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Contact: Marta Pereira, Master 934577699 ext +351 martinha.marquespereira@gmail.com
Contact: Graça Pereira, PhD 938471039 ext +351 gracep@psi.uminho.pt

Locations
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Portugal
António Fradão Recruiting
Viana Do Castelo, Estrada De Santa Luzia, Portugal, 4904-858
Contact: António Fradão, graduation    258 802 108 ext +351    internato.mgf@ulsam.min-saude.pt   
Contact: Luísa Azevedo, graduation    258 802 100 ext +351    luisa.azevedo@ulsam.min-saude.pt   
Sponsors and Collaborators
University of Minho
Investigators
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Principal Investigator: Marta Pereira, Master University of Minho

Publications:
Knobf T. Breast Cancer. In: Holland JC, Breitbart WS, Butow PN, Jacobsen PB, Loscalzo MJ, McCorkle R, editors. Psycho-Oncology. New York: Oxford University Press; 2012. p. 134-154.
Ahadi H, Delavar A, Rostami AM. Comparing Coping Styles in Cancer Patients and Healthy Subjects. Procedia Soc Behav Sci. 2014 Feb; 116(21):3467 - 3470. doi:10.1016/j.sbspro.2014.01.785.
Andryszak P. Izdebski P. Tujakowski J. [The influence of adjuvant chemotherapy on cognitive functioning of women with breast cancer - a literature review]. Nowotwory. Journal of Oncology 2012;62(4):291-304.
Lazarus RS, Folkman S. Transactional theory and research on emotions and coping. Eur J Pers. 1987;1(3):141-169. https://doi.org/10.1002/per.2410010304
Cohen MZ, White L. Cancer-Related Distress. In: Yarbro CH, Wujcik D, Gobel BH, editors. Cancer nursing: Principles and practice. Burlington, MA: Jones & Bartlett Learning; 2016. p. 759 - 779

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Responsible Party: Marta Alexandra Marques Pereira, Principal Investigator, University of Minho
ClinicalTrials.gov Identifier: NCT03585218     History of Changes
Other Study ID Numbers: 175519021995
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only cortisol values will be shared with other researchers in the field of oncology medicine for them to analyze the relationship between cortisol levels and the side effects reported by participants during chemotherapy treatment.
Supporting Materials: Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The data will be available in February 2020 and will be available for 5 years.
Access Criteria: The data will be shared with the collaborators involved in the research, for biochemical analysis (ELISA Kit -IBL) and statistics (SPSS Software). The principal investigator will be responsible for reviewing requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marta Alexandra Marques Pereira, University of Minho:
Quality of Life
Breast Cancer
Essentials Oils
Adjuvant Chemotherapy
Salivary cortisol
Neuropsychophysiology
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases