Clinical trial NCT03585218: Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life
Official title: Clinical, Emotional, Cognitive and Neuropsychophysiological Impact of a Hedonic Aroma in Women With Breast Cancer Undergoing Chemotherapy: Implications in Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Quality of Life
Breast Cancer
Essentials Oils
Adjuvant Chemotherapy
Salivary cortisol
Neuropsychophysiology
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Foundation for Science and Technology, Portugal
First posted: 2018-07-12
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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 before CT through the instrument smell diskettes and only in the EG participants

Primary outcomes:
measure: Quality of life - The experimental group presented, in comparison to the control group, lower level of QLQ
timeFrame: 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
measure: Anxiety and depression - The experimental group presented, in comparison to the control group, lower anxiety and depression
timeFrame: 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:
measure: Distress
timeFrame: 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
measure: Saliva cortisol
timeFrame: 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
measure: Subscales of the Quality of Life in Breast Cancer
timeFrame: 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
measure: Illness Perceptions
timeFrame: 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
measure: Self-efficacy for coping
timeFrame: 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
measure: Working memory
timeFrame: 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
measure: Cognitive Flexibility
timeFrame: 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
measure: Beliefs about chemotherapy
timeFrame: 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)
Other outcomes:
measure: Sociodemographic and Clinical Data
timeFrame: Time Frame: before chemotherapy (CT) treatment
measure: ECOG Performance Status (Oken et al., 1982)
timeFrame: Time Frame: before CT for inclusion criteria
measure: Smell Diskettes (Simmen, Briner & Hess, 1999).
timeFrame: Time Frame: before CT for inclusion criteria
measure: Short Assessment of Health Literacy (SAHL, Lee et al., 2010; Apolinario et al., 2012).
timeFrame: Time Frame: before CT for inclusion criteria
Locations:
city: Viana Do Castelo
country: Portugal
facility: António Fradão
state: Estrada De Santa Luzia
Study officials:
affiliation: University of Minho
name: Marta Pereira, Master
role: PRINCIPAL_INVESTIGATOR
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