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THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE

Volume 00, Number 00, 2017, pp. 1–7


ª Mary Ann Liebert, Inc.
DOI: 10.1089/acm.2017.0023

ORIGINAL ARTICLE

The Effect of Reflexology on the Pain-Insomnia-Fatigue


Disturbance Cluster of Breast Cancer Patients
During Adjuvant Radiation Therapy
Ricardo Tarrasch, PhD,1 Narin N. Carmel-Neiderman, MD,2 Sarah Ben-Ami, MSc,3
Bella Kaufman, MD,3 Raphi Pfeffer, MD,4 Merav Ben-David, MD,4,5 and Dorit Gamus, MD, PhD2

Abstract
Objective: To evaluate the effects of reflexology treatment on quality of life, sleep disturbances, and fatigue
in breast cancer patients during radiation therapy.
Methods/Subjects: A total of 72 women with breast cancer (stages 1–3) scheduled for radiation therapy were
recruited.
Design: Women were allocated upon their preference either to the group receiving reflexology treatments
once a week concurrently with radiotherapy and continued for 10 weeks or to the control group (usual care).
Outcome measures: The Lee Fatigue Scale, General Sleep Disturbance Scale, and Multidimensional Quality
of Life Scale Cancer were completed by each patient in both arms at the beginning of the radiation treatment,
after 5 weeks, and after 10 weeks of reflexology treatment.
Results: The final analysis included 58 women. The reflexology treated group demonstrated statisti-
cally significant lower levels of fatigue after 5 weeks of radiation therapy ( p < 0.001), compared to the
control group. It was also detected that although the quality of life in the control group deteriorated after
5 and 10 weeks of radiation therapy ( p < 0.01 and p < 0.05, respectively), it was preserved in the reflexology
group, which also demonstrated a significant improvement in the quality of sleep after 10 weeks of radia-
tion treatment ( p < 0.05). Similar patterns were obtained in the assessment of the pain levels experienced by
the patients.
Conclusions: The results of the present study indicate that reflexology may have a positive effect on fatigue,
quality of sleep, pain, and quality of life in breast cancer patients during radiation therapy. Reflexology
prevented the decline in quality of life and significantly ameliorated the fatigue and quality of sleep of these
patients. An encouraging trend was also noted in amelioration of pain levels.

Keywords: reflexology, radiation therapy, fatigue, breast cancer

Introduction 80% of the patients undergoing radiation treatment suf-


fer from fatigue,2 with a resultant decrease in quality of

C ancer-related fatigue (CRF) is one of the most


common side-effects among breast cancer patients dur-
ing adjuvant radiation treatment.1 It is estimated that about
life (QOL).
In addition to fatigue, patients undergoing radiotherapy
often experience poor sleep quality, which by itself might be

1
The Jaime and Joan Constantiner School of Education, Tel-Aviv University, Tel-Aviv, Israel.
2
Complementary and Integrative Medicine Service, Sheba Medical Center, Ramat-Gan, Israel.
3
Oncology Department, Sheba Medical Center, Ramat-Gan, Israel.
4
Radiation Oncology Department, Sheba Medical Center, Ramat-Gan, Israel.
5
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
This study was presented at: The International Congress on Integrative Medicine and Health (ICIMH), Las Vegas, Nevada,
May 17–20, 2016.

1
2 TARRASCH ET AL.

a risk factor for CRF. It has been reported that patients with Reflexology treatments were provided by a senior re-
breast cancer experience sleep disturbance more frequently flexologist, who graduated a 3-year course in one of the
and with a greater severity than patients with prostate can- colleges accredited by the Israeli Reflexology Association,
cer, although both populations report poor sleep quality and with 13 years of clinical experience. Treatment sessions
fatigue.3 followed a structured protocol and included a standardized
The pain-insomnia-fatigue symptom cluster is one of the protocol (20 min) of manipulation of the areas, which rep-
clusters (co-occurrence of symptoms) found in breast cancer resent body organs on plantar areas of the feet using sys-
patients during radiation treatment4 and if not adequately tematic massage horizontally and vertically (a crawling
managed, may affect mood, role performance, social func- method), and massaging of spleen, stomach, and heart ar-
tions, ability to tolerate and continue cancer therapies, and eas in a circular clockwise motion. This protocol was
overall QOL.5,6 It has been suggested therefore that these followed by an additional 10 min of individualized ap-
symptoms should be addressed as part of comprehensive proach adapted to each patient, according to her current
cancer care. symptoms and involved manipulations of plantar and
While there are limited pharmacologic interventions for dorsal areas of the feet.
CRF,7 several nonpharmacologic approaches have demon- The control group received no additional treatment.
strated encouraging results such as exercise8,9 and psycho- Fatigue, pain, QOL, and quality of sleep in both groups
logic interventions.10 were assessed by self-reported questionnaires at week 1 (as
Complementary and alternative medicine (CAM) thera- baseline), week 5, and week 10.
pies are gradually gaining more interest in cancer symptom All treatments were delivered at the Cancer Center of the
management.11 More than 50% of cancer patients in Israel Sheba Medical Center. The study was approved by the local
use complementary medicine.12 There is evidence for the Human Subject Review Board and registered at the Clin-
benefits of massage for symptom management of cancer icalTrials.gov NCT00825682.
patients. A systematic review and meta-analysis that eval-
uated the effect of massage interventions on treatment-
Tools
related side-effects of breast cancer patients demonstrated
that regular use of massage led to significantly greater re- Pain, fatigue, and depression are subjective phenomena
ductions in anger and fatigue symptoms.13 A prospective that are usually assessed by self-reported questionnaires and,
multicenter study of CAM utilization among breast cancer therefore, lack an objective evaluation. To minimize the
patients during radiation treatment demonstrated that mas- inherent bias, a pain-insomnia-fatigue cluster that has been
sage and reflexology comprised almost 40% of all CAM characterized by Pud et al. was evaluated, who also dem-
practices.14 In another study 40.1% of the women treated for onstrated that differences in functional status and QOL
primary breast cancer reported the use of CAM, reflexology based on different symptom experiences were not only
being the fifth most common method of treatment, and the statistically significant but also clinically significant.6 This
leading of the massage therapies group.15 cluster analysis is based on the Multidimensional Quality of
Reflexology is also known as ‘‘zone therapy’’ and in- Life Scale-Cancer questionnaire (MQOLS-CA), the Lee
volves manual stimulation of reflex points on the feet that Fatigue Scale (LFS), the General Sleep Disturbance Scale
somatotopically correspond to specific areas and organs of (GSDS), and a numeric rating scale of pain intensity. The
the body. It is based on the theory that all organs are re- Hebrew versions of these questionnaires were used, all trans-
presented by various points on the feet, forming a map of the lated and validated by Pud et al.6 as follows:
whole body, and that massaging specific areas of feet can The LFS16 assesses the degree of fatigue and energy and
affect corresponding target organs. includes 18 items that describe feelings and behaviors as-
Clinical experience indicated that reflexology might al- sociated with fatigue on a 0–10 Likert scale. The Cron-
leviate fatigue and sleep disturbances. The aim of this study bach’s a internal reliability coefficient of the English
was therefore to evaluate the effect of reflexology on fa- version is 0.9617 and of the Hebrew translation is 0.93.6 In
tigue, pain, and QOL in women with breast cancer during the present study the reliability obtained at the three time
adjuvant radiation therapy. points ranged between 0.90 and 0.94.
The GSDS18 examines several aspects of sleep disorders
and includes 21 items that describe feelings and behaviors
Methods associated with sleep and dealing with insomnia during the
previous week. It uses a 0 (never) to 7 (every day) Likert
Subjects
scale on questions such as feeling nervous during the day;
The study included 72 breast cancer patients scheduled for falling asleep while unplanned; and using sleeping pills. The
adjuvant radiation therapy for 6 consecutive weeks, 5 days a Cronbach’s a reliability coefficient of its English version is
week. Participants were recruited to the experimental or 0.77,17 and its validity and reliability have been established
control groups according to their preference. All patients in cancer patients.19 The reported Cronbach’s a internal
signed informed consent. Exclusion criteria included the reliability of the Hebrew version is 0.8.6 In this study, the
following: coagulation disorders and concurrent CAM treat- reliability coefficients obtained at the three time points were
ments outside the framework of this study. 0.71, 0.79, and 0.84, respectively.
Reflexology treatments were administered once a week The MQOLS-CA20 includes 44 items describing different
by a qualified therapist, began concurrently with radiation forms in which the disease may affect patient’s QOL. For
therapy, and continued for 10 weeks (for up to 4 weeks after each item, subjects are asked to mark the number that best
the completion of radiation treatments). describes their feelings right now, in a Likert scale ranging
REFLEXOLOGY FOR SYMPTOM RELIEF DURING RADIOTHERAPY 3

between 0 and 10. Items include feelings of happiness, treatment. For missing observations, ‘‘last value carried
anxiety levels, how the disease affects social ties, etc. The forward’’ method was used. Accordingly, the final analysis
reliability coefficient of the English version of the ques- included 38 women in the experimental group and 20 in the
tionnaire in different studies ranges between 0.67 and 0.96. control group.
The English validation of the questionnaire was based on the
correlations with other QOL measures and obtained signif-
icant correlations ranging between 0.37 and 0.65. The Demographic data
Cronbach’s a reliability coefficient of the Hebrew version of The participant’s age ranged between 31 and 77 years
the questionnaire is 0.89.6 The reliability coefficients in this (average = 53.7, SD = 10.8). There was no statistical differ-
study ranged between 0.90 and 0.93. ence between the two groups [t(56) = 0.71, p = 0.48]. Most of
The pain assessment was based on the Visual Analogue the women (77.6%) were married, 10.3% lived alone, and
Pain Scale (a 0–10 scale). Subjects were asked to rate the 59% had a diagnosis of additional chronic disease (asthma,
current pain level, the average pain level during the last diabetes, hypertension, hyperthyroidism, and epilepsy). There
week, and the maximal pain level during the last week. was no statistical difference in the prevalence of background
diseases between the groups (w2(1) = 1.63; p = 0.20).
Statistical analysis The patients in this study were all diagnosed with invasive
breast cancer (no ductal carcinoma in situ, stage 0 disease).
To test the hypotheses that the experimental group will
Locally advanced breast cancer (stage 3) was diagnosed among
show a greater reduction in the fatigue index, a greater
improvement in the sleep quality index, a greater im- 14 (29.8%) and 9 (36%) of the women; stage 2—among 19
provement in the QOL, and reduction in pain compared to (40.4%) and 10 (40%); and stage 1—among 14 (29.8%) and 6
(24%) of the women in the treatment and control arms, re-
the control group, repeated measurements of analyses of
variances were conducted with time of measurement as spectively. There was no statistical difference in cancer stage
the repeated measurements (three time points) and group between the two groups (w2 = 0.39, p = 0.82).
Upon the recruitment to the study no significant differ-
as the between-subjects effect. Significant effects were
followed by Fisher least significant difference post hoc ences were observed between the two groups in terms of
comparisons. fatigue levels, quality of sleep, QOL, current pain, average
pain, and maximum pain levels during the last week:
p-values of the differences between the groups as assessed
Results by t tests for independent samples were 0.62, 0.49, 0.61,
Seventy-two women were recruited to the study as fol- 0.25, 0.33, and 0.57, respectively (Table 1).
lows: 47 chose to participate in the experimental arm and 25 The analysis of the fatigue scale demonstrated a signifi-
women chose to participate in the control arm. The majority cant effect of time of measurement [F(2, 110) = 6.77,
of the patients who declined participation in the study (re- p = 0.002], and most importantly, a significant interaction
flexology) group did it as they were reluctant to arrive at the [F(2, 110) = 4.50, p = 0.01]. Fatigue levels increased in the
hospital on a weekly basis in addition to the already sched- control group between the first and second measurement
uled treatments and checkups. ( p < 0.001) and between the second and third measurement
Ten women, five from each group, did not begin the ( p < 0.05), while no increase in fatigue was observed in the
study. In addition, eight women from the experimental experimental group (Fig. 2).
group did not complete all reflexology treatments (Fig. 1). Figure 3 presents quality of sleep levels measured in both
Reasons for dropping out included: not attending the sec- groups at the three time points. A significant interaction
ond and/or third treatment due to personal reasons (lack between group and time was obtained for the sleep quality
of time, distance from the clinic, etc.). To reduce the bias, measure [F(2, 112) = 3.44, p = 0.04]. The source of the in-
a semi-intent-to-treat analysis was performed adding teraction stems from an improved sleep quality in the ex-
the four cases that dropped after the first measurement/ perimental group, as demonstrated by comparison between
the first and the third measures ( p = 0.02). No significant
effects of time or group were obtained.

Table 1. Means and Standard Deviations of the


Dependent Variables, in the Premeasure, Separately
for the Experimental and Control Groups
Experimental group Control group
Measure Mean S.D. Mean S.D.
Fatigue levels 3.92 1.86 3.68 1.56
Quality of sleep 2.53 0.96 2.35 0.84
Quality of life 4.27 1.35 4.09 1.13
Current pain 1.63 2.49 0.90 1.74
Average pain 1.95 2.49 1.30 2.20
Maximum pain 2.32 3.34 1.80 3.05
FIG. 1. Flow of participants through the trial.
4 TARRASCH ET AL.

FIG. 2. Interaction between time of measurement and FIG. 4. Interaction between time of measurement and
group on fatigue levels (Lee Fatigue Scale). Fatigue levels group on quality of life (Multidimensional Quality of
(Lee Fatigue Scale) of both groups measured at three time Life Scale-CA index). Quality of life (the Multidimen-
points: (1) at the beginning of the study, (2) after 5 weeks sional Quality of Life Scale-Cancer questionnaire index)
reflexology alongside radiation treatment, and (3) after 10 measured in the groups at three time points: (1) at the
weeks of reflexology treatment. beginning of the study, (2) after 5 weeks reflexology
alongside radiation treatment, and (3) after 10 weeks of
reflexology treatment.
The QOL (Fig. 4) was also assessed in both groups at the
three time points and demonstrated a significant interaction
between group and time [F(2, 112) = 4.06, p = 0.02]. The As can be seen in Figure 5a–c, while no significant dif-
source of the interaction stems from a significant reduction ferences were observed in the pain measures in the experi-
in the QOL in the control group in the second ( p = 0.01) and mental group, there was a significant increase in the current
third ( p = 0.03) measures. No significant effects of time or pain level in the control group between the first and the
group were obtained. second ( p = 0.01) and the third ( p = 0.03) measurements.
Pain levels throughout the study are presented in Figure 5. The average pain level also rose significantly in the control
There was no significant difference between the groups in group between the first and the second measurements
the percentage of women who reported suffering from pain ( p = 0.03) and declined between the second and the third
at presentation (w2(1) = 1.63; p = 0.20). The analyses of cur- measurements ( p = 0.02). A significant increase between the
rent pain, average pain during the last week, and maximum first and the second ( p = 0.003) and the third ( p = 0.05)
pain level during the last week yielded significant or mar- measurements of the worst pain level was also observed in
ginally significant interactions between group and time [F(2, the control group.
112) = 1.95, p = 0.15; F(2, 112) = 2.31, p = 0.10; and F(2,
112) = 3.81, p = 0.03], respectively.
Discussion
The effect of reflexology on the pain-insomnia-fatigue
symptom cluster in women with breast cancer was evalu-
ated, who received adjuvant radiation therapy. Postirradia-
tion fatigue may persist for a considerable period of time.
Reflexology treatment was continued therefore for 4 weeks
after the cessation of radiation treatment, to estimate the
effect of reflexology both as a concurrent treatment to ra-
diotherapy (assessed at 5 weeks since the beginning of the
study) and as a maintenance treatment after the cessation of
radiotherapy (assessed at week 10).
By the end of radiation treatment, significant differences
in fatigue, sleep, pain, and QOL were detected between the
reflexology and control groups: the control group experi-
enced significantly higher levels of fatigue during radio-
therapy, while no increase in fatigue was observed in the
reflexology group, which even showed a significant im-
provement in the quality of sleep. Furthermore, while the
FIG. 3. Interaction between time of measurement and
QOL in the control group deteriorated after 5 and 10 weeks
group on quality of sleep (General Sleep Disturbance Scale).
Quality of sleep levels (General Sleep Disturbance Scale) of radiation therapy, it was virtually unaffected in the re-
measured in both groups at three time points: (1) at the flexology group.
beginning of the study, (2) after 5 weeks reflexology While the mechanism of reflexology is still not clear, it
alongside radiation treatment, and (3) after 10 weeks of shares a common philosophical background with acu-
reflexology treatment. puncture and includes some elements of relaxation and
REFLEXOLOGY FOR SYMPTOM RELIEF DURING RADIOTHERAPY 5

onstrated that fatigue and sleep disturbances were the most


common symptoms improved by mind–body interventions,
while relaxation, which is often experienced during re-
flexology treatment, was reported to improve pain and
sleep disturbance. None of the studies however demon-
strated concurrent improvement in all three symptoms.
A recently published meta-analysis on massage therapy
in cancer pain found beneficial effect of massage for relief
of cancer pain, while reflexology appeared to be more
effective than body or aroma massage.23 A significant
difference between the levels of the worst pain between
the two groups at the second measurement ( p = 0.003) was
also demonstrated. Although a similar trend was noted
for the current pain and the average pain, the differences
between the groups did not reach statistical significance. It
is possible that a failure to detect a significant differ-
ence between the groups stems from a relatively small
sample size.
The most impressive result of this study was ameliora-
tion of CRF. This finding is in concordance with results of
other studies of CAM modalities. A large study found
significant improvement in postchemotherapy CRF and in
QOL after 6 weeks of acupuncture treatment.24 Iyengar
Yoga was reported to improve fatigue in breast cancer
survivors,25 and yoga treatment for breast cancer patients
provided during radiotherapy period also demonstrated a
reduction in fatigue compared with stretching exercise
group, but no between-group differences for sleep quality
were detected.26 Massage therapy in patients with ad-
vanced cancer was found to be superior to simple-touch
sessions for immediate pain and mood. However, no sig-
nificant differences were found between the groups in
sustained pain, worst pain, or QOL.27
The inflammatory origin of CRF, probably through acti-
vation of pro-inflammatory cytokine network, has been
suggested by the review on mechanisms, risk factors, and
treatments for CRF.28 It was also demonstrated that in-
creased levels of C-reactive protein and IL-1 receptor an-
tagonist were associated with increase in fatigue both in
early breast cancer and in prostate cancer patients undergo-
ing radiotherapy.29 Furthermore, a significant influence of
skin erythema on pro-inflammatory cytokines and fatigue in
breast cancer patients receiving adjuvant radiation therapy
was demonstrated.30
It is of interest to note that some of the CAM interven-
FIG. 5. Interaction between time of measurement and tions that had beneficial effect on CRF such as acupuncture,
group on pain level measurements. Current (a), average (b), yoga, and massage have also been reported to exert an anti-
and strongest (c) pain levels measured in the groups at three inflammatory activity.31–34 The previous study that dem-
time points: (1) at the beginning of the study, (2) after 5 onstrated amelioration of multiple sclerosis symptoms by
weeks reflexology alongside radiation treatment, and (3) reflexology35 may also indicate that reflexology treatment
after 10 weeks of reflexology treatment. might have an anti-inflammatory effect.
To the best of our knowledge, this is the first report on the
effect of reflexology on pain-insomnia-fatigue cluster in
massage treatments. Sharp et al. evaluated the effect of breast cancer patients during adjuvant radiation therapy. The
reflexology and massage versus self-initiated support (SIS) study had several limitations as follows: the patients were
on QOL following surgery for breast cancer. Both reflex- allocated to the experimental and control groups according
ology and massage had statistically significant effects on to their preference and not through a randomization proce-
QOL compared to SIS, which were clinically worthwhile dure. The two groups however were similar at the baseline
for reflexology.21 in terms of demographics, background diseases, the levels of
Findings of this study are in line with conclusions of the fatigue and sleep disturbances, QOL, or pain. In addition,
review of mind–body treatments for the pain-fatigue-sleep due to the lack of an active control group, it may be that the
disturbance cluster in cancer patients.22 This review dem- choice of participation in the reflexology group has resulted
6 TARRASCH ET AL.

in some expectations leading to an inherent bias. The sample cognitive-behavioral therapy plus hypnosis. Health Psychol
size was relatively small, but despite the small statistical power, 2009;28:317–322.
significant improvements in the reflexology group were able to 11. Finnegan-John J, Molassiotis A, Richardson A, et al. A
be demonstrated, compared with the control group. systematic review of complementary and alternative med-
icine interventions for the management of cancer-related
Conclusions fatigue. Integr Cancer Ther 2013;12:276–290.
12. Paltiel O, Avitzour M, Peretz T, et al. Determinants of the
The results of the present study indicate that reflexology use of complementary therapies by patients with cancer. J
may have a positive effect on fatigue, quality of sleep, pain, Clin Oncol 2001;19:2439–2448.
and QOL in breast cancer patients. 13. Pan YQ, Yang KH, Wang YL, et al. Massage interventions
In view of the fact that inadequate treatment of fatigue and treatment-related side effects of breast cancer: A sys-
may considerably compromise both the QOL of cancer pa- tematic review and meta-analysis. Int J Clin Oncol 2014;
tients and the adherence to treatment protocol, there is a need 19:829–841.
for the development of interventions for this debilitating 14. Moran MS, Ma S, Jagsi R, et al. A prospective, multicenter
symptom. Further randomized controlled studies of non- study of complementary/alternative medicine (CAM) uti-
pharmacologic approaches such as acupuncture, yoga, mas- lization during definitive radiation for breast cancer. Int J
sage, and reflexology should therefore be encouraged. Rad Oncol Biol Phys 2013;85:40–46.
15. Pedersen CG, Christensen S, Jensen AB, et al. Prevalence,
socio-demographic and clinical predictors of post-
Acknowledgment diagnostic utilization of different types of complementary
The authors are grateful to Mrs. Lihi Geva for providing and alternative medicine (CAM) in a nationwide cohort of
reflexology treatments to the patients. Danish women treated for primary breast cancer. Eur J
Cancer 2009;45:3172–3178.
16. Lee KA, Hicks G, Nino-Murcia G, et al. Validity and re-
Author Disclosure Statement liability of a scale to assess fatigue. Psychiatry Res 1991;
No competing financial interests exist. 36:291–298.
17. Gay CL, Lee K A, Lee SY, et al. Sleep patterns and
fatigue in new mothers and fathers. Biol Res Nurs 2004;
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