Cancer patients in
particular have sought out complementary therapies. Horneber et al.  reviewed studies of cancer
patients using complementary therapies and concluded that usage had risen from
32% in the 1990’s to 49% after 2000. Corner et al.  compared massage and aromatherapy treatments with 52
patients receiving eight weekly treatments, those receiving AM had a greater improvement in symptom control.
A number of cancer
support centres have incorporated complementary therapies into treatment
regimens for cancer patients. At one
centre, 58 patients (mainly female) and 40 per cent with a
main symptom of anxiety, completed HADS questionnaires following six AM
treatments, Kite  concluded
that AM has a role in reducing psychological distress and
improving symptom control in cancer patients. Harrington et al.
reported a service evaluation of users at three cancer
with breast cancer.
Patients received therapies to help
relieve cancer treatment side effects and completed the
Measure Yourself Concerns and Wellbeing (MYCaW) questionnaire before and after
six one-hour complementary therapies. Listing et al.  concluded massage improved mood and reduced physical
discomfort and fatigue.
Wilkinson et al.  found that AM
reduced psychological distress in the short term for cancer patients two
weeks after intervention, and Imanishi et al. 
reported this effect was measurable at four weeks. This finding is supported in reviews from Flemming  and Fellowes et al. .
Baum et al.  published a literature review
which concluded that complementary and alternative medicine including AM is
effective in decreasing anxiety levels and increasing quality of life. Wilkinson
et al.  reviewed the
evidence of the effectiveness of massage and AM for cancer patients in the
reduction of physical and psychological symptoms. They concluded that AM may
reduce anxiety in the short term and may improve the symptoms of pain and
nausea. Both of these concluded that larger trials and longer follow up periods were required
to confirm the efficacy and effectiveness of massage for cancer patients. Dunn et
al.  showed
significant improvements in anxiety and quality of life.
Boehm, Bussing and
Osterman  published a
descriptive systematic review of AM as an adjuvant treatment to cancer care, and
found short-term improvements in well-being, anxiety and depression but no long
The 'FORCE' cancer
support centre, situated on the site of the Royal Devon and Exeter NHS
Foundation Trust hospital, offers a range of complementary therapies to cancer
patients and their carers. Since the service started in 1997 it has received
very positive anecdotal feedback from patients who expressed improvement in
physical and emotional wellbeing, following complementary therapy treatments,
particularly the AM. As most previous studies were small and reviews called for
larger, well conducted trials, a randomized controlled trial was undertaken,
using validated questionnaires, to attempt to measure any benefits of AM
complementary therapy was available for all cancer types presenting at the centre,
in a scoping exercise of three months’ registrations, it was found that 43
percent were breast cancer patients, by far the largest
diagnostic group, and Boon et al.  reported that uptake of CAM is highest among breast cancer patients - up to 80 per cent. For ease of
recruitment, we therefore decided to study breast cancer patients. The aim of this research was to evaluate
whether AM is beneficial physically and emotionally for breast cancer
patients. The objectives of the study
were to conduct a randomized controlled trial of AM versus no additional
treatment, recruiting breast cancer patients at various stages of treatment and
to use validated outcome measures such as HADS Zigmond & Snaith,  and EORTC QLQ-C30 and EORTC
QLQ-BR23 (EORTC Charitable Trust)  focusing on pain, insomnia, nausea/vomiting, and emotional well-being
as well as the ability to cope and feelings of anxiety.
This was a
parallel arm, randomized controlled trial with 1:1 allocation to the two arms.
Eligible participants were breast cancer patients undergoing clinical treatment
or who had recently completed treatment and were therefore on follow-up
appointments. Inclusion criteria were any patient being treated for breast
cancer aged 18 or over. Exclusion criteria were psychotic patients and those
who did not meet the contraindications of aromatherapy. The setting was the complementary
treatment facility of the FORCE Cancer Charity based in Exeter, Devon, UK.
was granted by the North and East Devon Local Research Ethics Committee.
2.2. Recruitment, Consent and Randomization
patients (age range 18 to 86 years) were recruited by the researcher from those
requesting information about the centre's
complementary therapy service, or who were attending the service for additional
support. Patients contacting the researcher were given an information sheet and
had opportunity to discuss the trial. Those
recruited completed a consent form.
computer-generated randomization list was produced by the statistician and
random allocation was completed by the researcher-using sequentially numbered,
opaque envelopes and allocation was concealed from therapists until
interventions were assigned. All patients in both groups were given a code
number for anonymity which reflected the numbered set of questionnaires and a
prepaid envelope for returning the completed forms. All questionnaires once
returned were kept in a locked filing cabinet in a secure building.
It was not
possible to blind patients or therapists but the analyst was blinded to group
2.3. Intervention and Control
controlled trial offered the treatment group six appointments of AM once a week.
A small team of experienced aromatherapists carried out the treatments.
Whenever possible each aromatherapist would see the same patient for the
duration of their six AM appointments. The AM treatment was individualized:
there was a selection of seven essential oils (lavender, lemongrass, neroli,
grapefruit, bergamot, frankincense, sandalwood). The aromatherapist made an
individualized blend 1% from these oils for each patient, but the most common combination was lavender and bergamot. The oils
used and treatment given were recorded on the patient’s complementary therapy notes which were kept in a locked filing
cabinet. Patients were asked about any known allergy or sensitivity to these
oils and adverse reactions to them were noted. Patients in the control group
were put on a six
week waiting list for AM if they desired it.
2.4. Outcome Measures
were asked to complete two questionnaires, the HADS and the EORTC QLQ-C30 with
additional BR23 questions specific to breast cancer. The trial group were
staged at pre-treatment, after the third and sixth treatments.
The control group
completed questionnaires at baseline, three and six week intervals before being
offered complementary therapy. The primary outcome was pain as measured by the
EORTC questionnaire and the secondary outcomes included anxiety, depression, emotional
reactions, fatigue, insomnia, breast and arm symptoms, ability to cope, side
effects and future perspectives. These were also measured using the EORTC
2.5. Sample Size
The sample size
calculation was based on evaluation data
that had been collected from 133 patients with a variety of cancer diagnoses,
before treatment and after six weeks of complementary therapy treatment. 58 per
cent of patients were experiencing pain before treatment which had reduced to 42
per cent at six weeks. Based on these results, to be 80 per cent certain of
detecting a change in pain score of 16 percentage points at the five per cent
significance level, 153 patients per group would be needed (306 in total). In
the eventual trial, 135 treatments and 149 controls (284 in total) were
recruited and these were all breast cancer patients.
Analysis of Variance was used as the study design, which included a combination
of between subjects and within-subjects comparisons. Two arms of the trial were
being compared (Between Subjects) and also the three time points (Within
Subjects). Raw data were transferred from the EORTC and HADS questionnaires
into Excel spreadsheets manually. These were checked for errors and missing
data from unanswered questions were highlighted. Where possible, missing data
were replaced by imputed values according to the guidelines supplied by EORTC.
Domain scores, which are scaled from 0 to 100, were calculated and transferred
into new spreadsheets for analysis. Data analysis was completed using SPSS Inc.
Release 2009. PASW Statistics for Windows, Version 18.0. Chicago: SPSS Inc. The
analyst was blind to treatment allocation. Scores were tested for normality
using Shapiro-Wilk tests and inspection of plots and histograms. The trial data
were analyzed using SPANOVA, which also requires independence of data,
homogeneity of variances, sphericity (equal variances of repeated measurements:
Mauchly’s test) and homogeneity of inter-correlations (equal variance-covariance
matrices across between-subject’s effects: Box’s M test). If sphericity was violated, adjusted results (e.g.,
Greenhouse-Geisser) were interpreted. Results were expressed as mean domain
scores with 95% confidence intervals for precision.
All tests were
conducted at the five per cent
significance level. Baseline EORTC scores were compared with those from a
normal population (EORTC 2002). Cohen’s d effect
sizes, categorized as small (0.2), medium (0.5) or large (0.8), were calculated
for each outcome measure and EORTC domain Cohen . No radiotherapy or chemotherapy sub-group analyses were attempted as
there was insufficient power and a risk of Type II errors.
The mean age of
patients in the intervention group was 55.4 years (sd 10.89, range 34 to 86
years) and in the control group 55.62 years (sd 10.12, range 25 to 80 years).
The proportions having chemotherapy were: intervention 58 (42 per
cent) and control 72 (48 per cent). Those having radiotherapy were intervention 37 (27 per
cent) and control 36 (24 per cent). Among the baseline EORTC scores, only the emotional functioning score
was similar to that provided by EORTC (2002). The trial population scored
higher on physical functioning, fatigue and insomnia and lower on role
functioning and pain (see Table 1).
3.1. EORCT Pain Scores
There was no
significant difference in pain scores overall (p=0.409) and no significant
change in pain score in the AM group from baseline: 19.56 (95per cent CI 15.61
to 24.01); six weeks: 17.4 (95percent CI 13.08 to 21.72). Neither the breast or
arm symptoms were significantly different in main effects throughout the
six-week trial period (p=0.179 and p=0.483 respectively) (Table 2).
HADS Anxiety and Depression Scores (0 to 21)
Mean HADS Anxiety
scores were similar at baseline (AM group 7.15; control: 7.2) but improved in
the AM group to 5.2 (95 per cent CI: 4.41 to 5.99) at six weeks while remaining
relatively unchanged in the control group 7.07 (95 per cent CI: 6.27 to 7.87).
This gave a significant time by group interaction (p<0.001) but no overall
difference between subjects (p=0.076). The cutoff for HADS anxiety and
depression caseness is 8/21 Bjelland et al. . There were 45 (42 per cent)
anxiety cases in the aromatherapy group at baseline and 43 (41 per cent) in the
control group. This reduced to 29 (26 per cent) after 6 weeks’ treatment but
increased in the control group to 46 (44 per cent).
depression scores were not significantly different at baseline: AM 3.93 (95 per
cent CI 3.33 to 4.53); control: 4.63, (95 per
cent CI: 4.02 to 5.24) but while control group depression
scores continued to worsen over six weeks, those in the AM group improved (see Figure 1), giving AM 3.5
per cent CI 2.9 to 4.1); control: 5.14 (95 per
cent CI: 4.53 to 5.75) at that time and significant
between subject’s effects (p=0.003). There were 15 (13 per cent) depression cases in the aromatherapy group at baseline and 23
(21 per cent) in the control group. This reduced to 12 (10.9 per cent) after
treatment but increased in the control group to 30, (28 per cent).
EORTC Emotional Functioning Scale (0 To 100)
functional scales of EORTC-30 were the same at baseline but while control
scores remained relatively unchanged over six weeks, mean AM scores improved
from 68.58 to 79.57 (see Figure 2). The difference
between the two groups overall was significant (p=0.045): AM 79.57 (95 per cent CI
75.71 to 83.43); control group 69.23, (95 per cent CI 65.27
to 73.19). Neither physical nor role
functioning were significantly different in main effects overall (p=0.330 and
p=0.228 respectively). EORTC symptom scores (0 to 100).
Mean EORTC symptom
scores of fatigue improved from 38.73 to 32.6 in six weeks in the AM group but
remained relatively unchanged in the control group (41.03 at baseline and 40.68
at six weeks). However, this difference at six weeks did not reach
significance (p=0.056): AM score 32.6, (95 per cent CI 28.16 to 37.03); control
group 40.68, (95 per cent CI 36.13 to 45.22).
insomnia scores improved steadily in the AM group, they also began to drop in
the control group but rose again at six weeks. This resulted in no overall
significant difference between the groups (p=0.454): AM insomnia score at six
weeks 32.47, (95per cent CI 26.84 to 38.11); control group score 40. 07, (95per
cent CI 34.28 to 45.87).
3.4. EORTC Side Effects and Future
There were no
significant differences in side effects or the patient’s future perspectives over the six-week trial period (p=0.179 and
p=0.256 respectively). No serious adverse events occurred during the trial and
no adverse reactions to the aromatherapy massage were recorded.
When this research
was planned, much of the data available from other studies had been collected from palliative care patients. This trial included
patients who were undergoing clinical treatment, or who had recently completed
treatment and were therefore on follow-up appointments. Molinaro et al.  stated the scarcity of
articles when researching.
Many of the
previously published studies on the outcomes of AM and massage treatment of
cancer patients have been criticized for their limited sample size and lack of randomization
of controls. Ernst  and Boehm et al.  carried out literature reviews
and highlighted such limitations, concluding that this subject warranted
further investigation in order to provide more conclusive data. The current
study addresses these two issues by using a large number of participants in a randomized
Jane et al.  in reviewing the literature
showed that massage had positive effects on pain, anxiety and depression. They identified that future studies would
benefit from an extended number of massages and larger sample sizes.
The patients in
the study were all women with breast cancer.
Most of the improvements in the AM group relative to the control group were
in anxiety, depression, fatigue and emotional functioning. Medium effect sizes were observed for HADS
anxiety (0.44), HADS depression (0.5), EORTC emotional functioning (0.51) and
EORTC fatigue (0.34). Whilst insomnia, physical and role functioning, breast
symptoms, side effects and future perspectives were not significantly different
from the control group and had small effect sizes (around 0.2). Other symptoms
such as pain and arm symptoms, were not significantly different.
A weakness of the
that some data were not returned or not completed on some
of the questionnaires. Also, many of the patients were still receiving
chemotherapy/radiotherapy and therefore some did not feel well enough to attend
sessions and some lived a considerable distance from the centre. 58 (20 per
cent) participants dropped out by the end of six weeks mostly in the control
group (42, 28 %). The sample size was based upon data from a group of patients
who were not all breast cancer patients but had other cancers. It is possible
that pain was more of an issue for this group, so that the study was powered on
a variable (Pain) that was not the most relevant for breast cancer patients.
Blocking would have helped to keep numbers in both arms of the study even at
all times. With questionnaires there is always the possibility for response
bias to occur but this is less likely with the validated, self-completed EORTC
cancer questionnaires used in this study. Although there is an effect on
emotional status, anxiety and depression in this study, it is difficult to say
what was responsible for this effect: the essential oils, the AM, or having
time to relax in a quiet environment with the undivided attention of an
aromatherapist. Any one of these in isolation or in combination may be
Strengths of the
study are that this was a large trial with adequate participant numbers
recruited into each of the two arms, in agreement with the sample size
calculation. Six treatments were received. The researcher recruited all
patients to this trial with concealment of random allocation from the
aromatherapists, thus minimizing any selection bias. The same aromatherapist treated the patient
throughout their treatments whenever possible which provided consistency in the
application of the essential oils. As
the EORTC questionnaire does not fully cover all aspects of psychological
symptoms, a second validated questionnaire, HADS was also used.
Cawley  reviewing the evidence for the benefits of massage in
general, demonstrated it to be effective for a range of conditions. Fourteen research studies were found, dating
from 1982 to 1996. The aims were focusing on improvements in relaxation, coping
with symptoms/symptom distress, mood, pain, anxiety states, depression, stress,
psychological wellbeing and quality of life. Only eight studies had a
statistical analysis and all reported significant improvements in outcomes. Six
of the studies involved cancer patients and all but one study was statistically
analyzed and they reported significant improvements in outcome such as anxiety,
symptom distress, heart rate, pain (Males) and quality of life. Three of the 14
studies reviewed included AM. Cooke and Ernst  published a systematic review of evidence for the effectiveness of AM.
Of the 12 trials identified, the six trials of AM massage were concentrated
upon; the remaining six studies were unique comparisons of different AM
interventions. These studies suggested that AM massage had a mild, transient
anxiolytic effect. However, they argued that the effects of AM were probably
not strong enough for it to be considered for the treatment of anxiety. The
hypothesis that it is effective for any other indication was not supported by
the findings of rigorous clinical trials.
We conclude that
the provision of AM is a useful adjunct to conventional treatment for patients
with breast cancer. There were improvements in emotional functioning and a
reduction in anxiety and depression which were sustained for at least ten weeks
from the commencement of the weekly one-hour therapy sessions provided over a six-week
of the results reported here for clinical practice are for AM to be offered
alongside orthodox treatments and as a part of integrated supportive cancer care. Further research would benefit from expanding this to selecting
patients from other cancer groups and the involvement of male patients. AM
could be provided on the wards with the expectation of improving patients’
symptoms, emotional states and well-being.