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Breast Cancer FemaleNCT03585218

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

A study testing Inhalation of essential oils in people with Breast Cancer Female, run by University of Minho at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Inhalation of essential oils
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 sitePortugal
Study dates
6 Mar 2017to 4 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • António Fradão

    Viana do Castelo, Estrada de Santa Luzia, 4904-858

Other trials in Portugal

About this study

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

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.

Read the detailed description

The sample is non-probabilistic, consisting of 56 participants in the control group (CG) and 56 in the experimental group (EG). According to the calculations made for RCT studies (Noordzij et al., 2010), it will take approximately a total of 100 participants (50 participants per group) to detect a 10-point difference between the groups in the result variable QoL (e.g. EORCT QLQ-C30), with a population standard deviation of 15.43, according to previous study data (Lua et al., 2015), assuming a power of 90% and a significance level of 5%.

This study contemplates four moments of evaluation: T1 (baseline: 2nd Cycle of CT but before intervention), T2 (6 weeks - 3rd Cycle), T3 (9 weeks - 4th Cycle) and T4 (3 months after the end of the CT). These moments were chosen taking into account the classes of drugs used in the CT. Each cycle has an interval of 21. This is a randomized controlled clinical trial (RCT) being single blind (the participant does not know which group he belongs to, only the investigator) and longitudinal.

Intervention procedure:

From the 2nd. Chemotherapy cycle (T1), the GC received the standard chemotherapy treatment; while the EG, in addition to the standard chemotherapy treatment, inhaled a hedonic aroma selected at the time of the chemotherapy (among three types of essential oils: bergamot, exotic verbena and geranium). The participant, as she received the CT, would inhale the aroma in a phased manner and under the supervision of the researcher, until the end of the treatment (about two hours). This intervention took place over three cycles of CT (2nd, 3rd and 4th Cycles). Inhalation was carried out using cotton rolls impregnated with the selected oil, since the more directly the odoriferous molecules are applied to the nose, the greater their impact into the organism (Schneider, 2016). However, since it was necessary that the researcher supervised the participants during the inhalation process, the number of times the researcher was in contact with participants from both groups (GC and EG) were the same: 4 times during the chemotherapy treatment to assure the participants from the EG would not have more contacts what could bias the results.

Being tested
Inhalation of essential oils
Keywords
Quality of Life, Breast Cancer, Essentials Oils, Adjuvant Chemotherapy, Salivary cortisol, Neuropsychophysiology
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03585218
Study groupRoleWhat they receive
Experimental GroupExperimentalThe 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.
Receives: Biological: Inhalation of essential oils
Control GroupNo interventionThe control group is not subject to intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life - The experimental group presented, in comparison to the control group, lower level of QLQ

    Assessment instruments: the European Organization for Research and Treatment of Cancer - Quality of Life (EORTC QLQ-C30) (Aaronson et al., 1993; Pais-Ribeiro, Pinto \& Santos, 2008). 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)

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  2. Anxiety and depression - The experimental group presented, in comparison to the control group, lower anxiety and depression

    Assessment instruments: Hospital Anxiety and Depression Scale (HADS, Pais-Ribeiro et al., 2007) comprising both anxiety and depression scales. Scores range between 0 and 42 (anxiety between 0 and 21 and depression the same), with higher results indicating higher levels of distress.

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

Secondary outcomes (8)

  1. Distress

    Assessment instruments: Emotions Thermometer (TE, Mitchell, Baker-Glenn, Granger, \& Symonds, 2010; Teixeira et al., 2019) consisting of five analogue-visual scales, with four domains to identify emotional complications (distress, anxiety, depression, anger) and one outcome domain (need for help). In each thermometer de scores range between 0 and 10. A high result indicates emotional distress.

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  2. Saliva cortisol

    The collection of saliva for the evaluation of cortisol concentrations was performed using salivettes® (Starsedt). The procedure to assess salivary cortisol concentrations was implemented according to the protocol stipulated by IBL International (Cortisol Saliva ELISA, IBL International GMBH).

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  3. Subscales of the Quality of Life in Breast Cancer

    Assessment instruments: the European Organization for Research and Treatment of Cancer - Quality of Life, Module for Breast Cancer (EORTC QLQ-BR23, Sprangers et al., 2006. In this study, only the breast symptoms (scores range between 4-16), body image (scores range between 4-16), sexual functioning (scores range between 2-8) and side effects (scores range between 7-28) subscales were used. High scores indicate higher body image, sexual functioning and breast symptoms.

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  4. Illness Perceptions

    Assessment instruments: Illness Perception Questionnaire (IPQ-Brief, Broadbent, Petrie, Main, \& Weinman, 2006; Figueiras et al., 2010). This instrument comprises 9 items that assess patients' cognitive and emotional representations of the disease. There is one item that is open-ended and asks the perceived causes of the disease (not used in the study). Scores range between 0 and 80. Higher scores indicate a more threatening illness perception.

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  5. Self-efficacy for coping

    Assessment instruments: Cancer Behavior Inventory-Brief Version (CBI-B, Heitzmann et al., 2011). This instrument evaluates self-efficacy for coping in cancer patients through 12-item. Scores range between 12 and 108 and higher scores indicate more effective coping strategies.

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  6. Working memory

    Assessment instruments: WAIS III Subtest - Digit Span (Wechsler, 2008). It evaluates patients' working memory in clinical practice consisting of two parts: The Digit Span Forward (scores range between 0-16 maximum) and Digit Span Backward (DSB) (scores range between 0-14 maximum). High scores indicate high immediate auditory memory and working memory.

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  7. Cognitive Flexibility

    Assessment instruments: Trail Making Test (TMT, Partington \& Leiter, 1949; Cavaco et al., 2013). This instrument is composed of part A, which evaluates attention, visual tracking and speed of graphomotor coordination and information processing; and Part B evaluates Part A functions and the ability to switch between a set of stimuli. Lower raw indices and higher adjusted scores correspond to better cognitive performance.

    Measured: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months

  8. Beliefs about chemotherapy

    Assessment instruments: Beliefs about chemotherapy (BMQ, Horne, Weinman, \& Hankins, 1997; Pereira, Pedras, \& Machado, 2013). This instrument is composed of 18 items and comprises two sections: BMQ - Specific and BMQ-General. In this study, only the specific section was used regarding chemotherapy. The BMQ - Specific section incorporates two sub-scales of five items each: Specific Needs and Specific Concerns related to the dangers of dependence and toxicity and concerns regarding long-term side effects, respectively. The total on the Specific Needs Scale ranges from 5 to 25 and on the Specific Concerns Scale from 5 to 25. Higher scores in each subscale indicate stronger beliefs regarding the need of treatment and regarding concerns towards the treatment, respectively.

    Measured: Changes from the 2nd cycle of chemotherapy (T1) (each cycle takes, on average, 2 hours with 3-week intervals between each cycle) until the date of 4th cycle of CT, assessed up to an average 1,5 months (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start6 Mar 2017
  3. Primary completion4 Apr 2019
  4. Study completion4 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
On each moment of data collection, the researcher will apply the evaluation protocol to the participant regardless of the group and before chemotherapy treatment. Regarding the psychophysiological variable, each participant's saliva will be collected using salivettes®, while cortisol concentrations will be analyzed through ELISA kits. At the time of the sample collection, before the CT, the participant who accepted to participate and fulfilled the inclusion criteria will be provided with three salivettes and an explanatory leaflet so that, on the day before the 2nd Cycle, they can collect their own saliva, around 23h, and on the day of CT, on waking up and thirty minutes after, fasting. This process will be replicated throughout the remaining evaluation moments. Subsequently, it is also our goal to evaluate the cortisol levels to CT by performing one collection of saliva before and another thirty minutes after CT.
Masking
Single blind
Who is masked
Participant
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03585218
Sponsor's protocol ID
175519021995
Status last verified
Aug 2021
First submitted
28 May 2018
Last updated
5 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PubMed 8433390

  • Apolinario D, Braga Rde C, Magaldi RM, Busse AL, Campora F, Brucki S, Lee SY. Short Assessment of Health Literacy for Portuguese-speaking Adults. Rev Saude Publica. 2012 Aug;46(4):702-11. doi: 10.1590/s0034-89102012005000047. Epub 2012 Jul 10.

    PubMed 22782124

  • Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.

    PubMed 16731240

  • Cavaco S, Goncalves A, Pinto C, Almeida E, Gomes F, Moreira I, Fernandes J, Teixeira-Pinto A. Trail Making Test: regression-based norms for the Portuguese population. Arch Clin Neuropsychol. 2013 Mar;28(2):189-98. doi: 10.1093/arclin/acs115. Epub 2013 Jan 7.

    PubMed 23299183

  • Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961.

    PubMed 20204931

  • Heitzmann CA, Merluzzi TV, Jean-Pierre P, Roscoe JA, Kirsh KL, Passik SD. Assessing self-efficacy for coping with cancer: development and psychometric analysis of the brief version of the Cancer Behavior Inventory (CBI-B). Psychooncology. 2011 Mar;20(3):302-12. doi: 10.1002/pon.1735.

    PubMed 20878830

  • Lee SY, Stucky BD, Lee JY, Rozier RG, Bender DE. Short Assessment of Health Literacy-Spanish and English: a comparable test of health literacy for Spanish and English speakers. Health Serv Res. 2010 Aug;45(4):1105-20. doi: 10.1111/j.1475-6773.2010.01119.x. Epub 2010 May 24.

    PubMed 20500222

  • Mitchell AJ, Baker-Glenn EA, Granger L, Symonds P. Can the Distress Thermometer be improved by additional mood domains? Part I. Initial validation of the Emotion Thermometers tool. Psychooncology. 2010 Feb;19(2):125-33. doi: 10.1002/pon.1523.

    PubMed 19296462

  • Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant. 2010 May;25(5):1388-93. doi: 10.1093/ndt/gfp732. Epub 2010 Jan 12.

    PubMed 20067907

  • Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and health. 1999; 14(1): 1-24.

  • Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

    PubMed 7165009

  • Pais-Ribeiro JL, Pinto C, Santos C. Validation study of the Portuguese version of the QLC-C30-V. 3. Psicologia, Saúde & Doenças. (2008; 9(1): 89-102.

  • Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.

    PubMed 17365902

  • Partington JE, Leiter RG. Partington's pathway test. Psychological Service Center Bulletin. 1949; 9-20.

  • Schneider R. There Is Something in the Air: Testing the Efficacy of a new Olfactory Stress Relief Method (AromaStick(R)). Stress Health. 2016 Oct;32(4):411-426. doi: 10.1002/smi.2636. Epub 2015 Mar 18.

    PubMed 25787105

Questions about this trial

What is this clinical trial studying?

A study testing Inhalation of essential oils in people with Breast Cancer Female, run by University of Minho at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life - The experimental group presented, in comparison to the control group, lower level of QLQ (time frame: Changes from the 2nd cycle of CT(T1) (each cycle takes, on average, 2 hours with 3-week intervals) until 4th cycle of CT, assessed up to an average 1,5 months (T3) and again in the follow up (T4) (3 months after to the end CT, an average 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03585218, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.

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