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Measuring Hot Flashes in Men
Treated With Hormone Ablation
Therapy: An Unmet Need
Michael W. Kattan
A
ccording to the National
Cancer Institute, more
than 230,000 new cases
of prostate cancer will
occur in the United States in 2005.
Prostate cancer is the second leading cause of cancer death in
men, with an estimated 29,900
deaths in 2004 (American
Cancer Institute, 2004). The standard palliative treatment for men
with advanced disease is testosterone suppression, which can
be accomplished through bilateral orchiectomy or through the
administration of estrogens or
luteinizing hormone-releasing
hormone (LHRH) analogues
(Sartor et al., 2003). Common
adverse effects associated with
the use of androgen ablation in
men with prostate cancer
include sexual dysfunction;
gynecomastia; changes in body
composition, metabolism, and
the cardiovascular system; osteoporosis; anemia; psychiatric and
cognitive disorders; fatigue and
overall diminished quality of
life; and hot flashes (Chen &
Petrylak, 2004).
The incidence of hot flashes
in men undergoing androgen
deprivation therapy has been
estimated at 55% to 80%; however, the true incidence of hot
flashes secondary to hormone
Michael W. Kattan, PhD, is
Chairman, Department of Quantitative
Health Sciences, Cleveland Clinic
Foundation, Cleveland, OH.
Note: CE Objectives and Evaluation
Form appear on page 21.
Hot flashes are a common problem in men who undergo orchiectomy
or treatment with androgen ablation therapy for prostate cancer. The
analysis of this symptom has relied on the use of subjective tools
such as patient diaries, but such approaches have been associated
with problems in validity and reliability. Although developed to measure the impact of hot flashes in breast cancer survivors, the Hot
Flash Related Daily Interference Scales (HFRDIS) exhibited high
internal consistency and validity; its use should be considered in
men who experience hot flashes. Additional reliable tools are needed
to subjectively and objectively evaluate the impact of hot flashes in
patients who receive androgen suppression therapy.
ablation therapy has not been
well documented nor accurately
measured (Higano, 2003). Among
patients who underwent orchiectomy, 58% to 76% experienced
hot flashes (Frödin, Alund, &
Varenhorst, 1985; Charig &
Rundle, 1989, as cited in Karling,
Hammar, & Varenhorst, 1994).
Vasomotor hot flashes are characterized by a subjective sensation
of increased temperature that
typically occurs in the upper
body and face. Peripheral vasodilation causes a visible reddening
of the skin and is followed by
profuse sweating. Often, hot
flashes occur spontaneously;
however, they may be triggered
by external factors such as
changes in the ambient temperature, ingesting hot fluids, or
changes in body position
(McCallum & Reading, 1989, as
cited in Smith, 1994). Mild hot
flashes may be tolerable.
However, moderate hot flashes
may produce a level of discomfort that is sufficient to interfere
with daily activities, and severe
hot flashes may be incapacitating
UROLOGIC NURSING / February 2006 / Volume 26 Number 1
(Walsh & Worthington, 1995, as
cited in Higano, 2003). Treatment
of hot flashes in men undergoing
androgen deprivation therapy
includes diethylstilbestrol and
other estrogens, megestrol acetate,
medroxyprogesterone acetate, and
venlafaxine (Higano, 2003).
In pre and post-menopausal
women, hot flashes are a natural
consequence of decreasing estrogen levels. However, hot flashes
are not observed in healthy men,
despite the decrease in serum
testosterone levels that is associated with aging-related Leydig
cell dysfunction (Smith, 1994).
The most widely accepted theory
on the pathogenesis of hot flashes involves the dynamic reduction (momentum) of sex hormones rather than their absolute
levels (Kouriefs, Georgiou, &
Ravi, 2002). The negative feedback of plasma sex hormones is
thought to regulate the generation of hot flashes. Peripheral sex
hormones activate the production of hypothalamic-endorphin
and catecholestrogen, which
inhibits the synthesis of hypo-
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thalamic noradrenaline. When
sex hormone levels are dynamically reduced, there is a loss of
negative feedback resulting in
increased levels of hypothalamic
noradrenaline. As a result, LHRHsecreting neurons are stimulated
to secrete gonadotropin. LHRH
neurons in the thermoregulatory
center are reset by the increased
intrahypothalamic noradrenaline,
resulting in hot flashes (Kouriefs
et al., 2002). The pathogenesis of
hot flashes may also involve
vasodilatory neuropeptide calcitonin gene-related peptide, a
potent endothelium-dependent
vasodilator of systemic blood vessels (Spetz, Hammar, Pettersson,
& Varenhorst, 2002).
Hot Flashes Are Not
Self-Limiting
Some researchers believe
that hot flashes associated with
the treatment of prostate cancer
are self-limiting; therefore, this
condition has received little
attention in the published literature. However, hot flashes are
reported to persist long after
chemical or surgical castration
(Karling et al., 1994; Schow,
Renfer, Rozanski, & Thompson,
1998; Spetz et al., 2001). One
study reported that hot flashes
persisted for up to 8 years in
more than 40% of patients with
prostate cancer who underwent
surgical (orchiectomy) or medical castration (Karling et al.,
1994). Another study of 43
patients who received neoadjuvant hormonal therapy prior to
radical prostatectomy reported
that 11% of patients continued to
experience hot flashes for up to
37 weeks after treatment was discontinued. The highest incidence of hot flashes was reported
in patients who had received
hormonal therapy for more than
4 months (Schow et al., 1998). In
postmenopausal women, vasomotor symptoms often disappear
after 2 to 5 years, but they have
been reported to persist for more
than 10 to 15 years (Berg,
14
Gottwall, Hammar, Lindgren, &
Gottwall, 1988; Kronenberg,
1990, as cited in Karling et al.,
1994).
Methods Used to Monitor
Hot Flashes in Men
The measurement of an
intangible, subjective symptom
such as hot flashes is associated
with unique methodologic challenges (Sloan et al., 2001). At this
time, there is no validated
method for evaluating the severity of hot flashes in patients with
prostate cancer (Higano, 2003;
Sloan et al., 2001). In oncology
clinical trials, self-reported
patient diaries have been used to
collect information over several
months; this approach has been
advocated for obtaining data on
subjectively assessed symptoms
(Maunsell, Allard, Dorval, &
Labbe, 2000; Richardson, 1994;
Ross, Rideout, & Carson, 1994;
Sherliker & Steptoe, 2000).
However, limitations of selfreporting methods include issues
of reliability and validity, and
missing data can be a problem.
One study found that the use of
daily diaries was associated with
incomplete data for 14% of
patients (Loprinzi et al., 1994).
The reliability of questionnaires
or diaries depends on high
response rates (Karling et al.,
1994). When data are missing,
response rates may be increased
by means of telephone interviews. Other limitations of selfreporting methods include not
reporting data prospectively or
accurately (Barton et al., 2002a).
If patients do not report data
prospectively, accuracy becomes
questionable, as it would be difficult to record the exact number
and severity of hot flashes that
were experienced during the
prior week. Likewise, retrospective measures of data collection
such as patient interviews may
be subject to the effects of mood,
emotion, and treatment expectations (Miller & Li, 2004).
Collecting data on hot flashes
from patient charts may also be
unreliable because of underreporting; one study found that
notes on hot flashes appeared in
the charts of only 24 of 43
patients who experienced these
symptoms (Karling et al., 1994).
Despite these weaknesses, a
number of researchers have used
subjective methods to assess hot
flashes in patients.
Instruments used to evaluate
the efficacy of therapy for hot
flashes in clinical trials involving
men with prostate cancer have
included patient diaries and
questionnaires, visual analog
scales, and direct questioning
(Barton et al., 2002b; Bressler,
Murphy, Shevrin, & Warren,
1993; Gerber, Zagaja, Ray, &
Rukstalis, 2000; Loprinzi et al.,
1994; Spetz et al., 2001). A study
of 12 men with advanced
prostate cancer who experienced
moderate to severe hot flashes
while receiving leuprolide used a
combination of methods including daily logs, a questionnaire,
and a visual analog scale to rate
hot flashes during treatment with
estrogen (Gerber et al., 2000). The
daily log was designed to evaluate the frequency, severity, and
duration of hot flashes and was
completed at the end of weeks 1,
5, 9, and 13. Because the results
from the daily logs were similar
for each week, the investigators
used results from the questionnaires to report changes in the
duration of hot flashes and the
visual analog scale to interpret
changes in severity (Gerber et al.,
2000). Another small study of
four men evaluated the efficacy
of clonidine for hot flashes secondary to leuprolide or goserelin
therapy and assessed treatment
response (severity, frequency,
and duration of hot flashes) via
patient interview (Bressler et al.,
1993).
The Assessment of Hot
Flashes During Quality-ofLife Studies
Hot flashes may affect psy-
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chosocial status and, if severe
enough, functional status. Many
quality-of-life (QOL) studies in
patients with prostate cancer
have included questions to
assess the incidence and/or
severity of hot flashes (Albertsen,
Aaronson, Muller, Keller, & Ware,
1997; Clark et al., 1997; Fossa, 1996;
Krupski, Petroni, Bissonette, &
Theodorescu, 2000; Ward-Smith,
Wittkopp, & Sheldon, 2004).
However, there are no known
QOL instruments to specifically
evaluate the impact of hot flashes
in men with prostate cancer.
Studies in men with prostate cancer have used a general questionnaire and a prostate-specific
module to evaluate QOL in this
population (Albertsen et al.,
1997; Clark et al., 1997; Krupski
et al., 2000; Wei, Dunn, Litwin,
Sandler, & Sanda, 2000).
One study assessed QOL in
men with prostate cancer by
means of a 12-item questionnaire, which evaluated symptom
severity including hot flashes,
and the Functional Assessment
of Cancer Therapy (FACT-G), an
instrument that reports general
QOL issues relating to personal,
social/family, emotional, and
functional well-being in relation
to cancer (Cella et al., 1993;
Krupski et al., 2000). Interestingly,
this study reported a high correlation between the findings of the
FACT-G and symptom severity.
These data suggested that hot
flashes may impact QOL (Krupski
et al., 2000).
A similar method was used in
an earlier study to assess QOL in
men with advanced prostate cancer in remission (Albertsen et al.,
1997). The investigators used a
prostate-specific module that was
developed for use during the
study, which evaluated urinary
symptoms and sexual functioning
as well as single-item measures
such as weight loss, weight gain,
and hot flashes. Other questionnaires included the European
Organization for Research and
Treatment of Cancer Core Quality
of Life Questionnaire (EORTC
QLQ-C30) and the Medical
Outcomes Study Short Form
Health Survey (SF-36) (Aaronson
et al., 1993; Ware & Sherbourne,
1992, as cited in Albertsen et al.,
1997).
The Expanded Prostate Index
Composite (EPIC) was designed
to address the limitations of
existing prostate-specific QOL
instruments; these limitations
include a lack of validated multiitem summary scores to specifically measure the effects and related
bothers of hormonal therapy (Wei
et al., 2000). EPIC measures androgen-deprivation symptoms and
related bother in urinary, bowel,
sexual, and hormonal domains;
the hormonal domain evaluates
hot flashes, depression, weight
gain, and fatigue. A study that
used EPIC to compare QOL
among patients who underwent
brachytherapy, external-beam
radiation, or radical prostatectomy reported a significant difference in hormonal QOL between
patients with progression-free
disease and those with increasing prostate-specific antigen levels (Wei et al., 2002).
The use of symptom-specific
tools is important for evaluating
QOL as nonspecific instruments
have been associated, in part,
with the failure to distinguish
between patients with no or mild
hot flashes and those with severe
hot flashes, despite trends noted
between these groups in physical
and emotional functioning.
Standard QOL measures were
designed to serve as global measures of functioning and not as
disease or symptom-specific tools
(Carpenter, 2001). Furthermore,
historical studies have measured
QOL using pain scores and performance status; however, other factors such as social interactions
and mental health can have a
considerable impact on QOL
(Albertsen et al., 1997). In
patients with prostate cancer,
body image, masculine image,
and self-image have been report-
UROLOGIC NURSING / February 2006 / Volume 26 Number 1
ed to correlate with symptoms
such as hot flashes (Clark et al.,
1997). Therefore, a symptomspecific instrument is needed
that measures the daily impact of
hot flashes on psychosocial and
functional status. Such an instrument would allow the health care
community to gain insight as to
how men perceive the effects of
hot flashes in relation to their
well-being during treatment of
prostate cancer.
QOL is an important factor
that should not be ignored,
because it may have a substantial
effect on treatment decisions and
comparisons (Kattan, 2003).
Patients and physicians may use
QOL data to help weigh the
advantages and disadvantages of
various treatment regimens. For
example, when QOL issues are
considered, less-effective treatments for the underlying disease
may be preferred to those that are
associated with more favorable
outcomes (McNeil, Weichselbaum,
& Pauker, 1978, 1981; McQuellon
et al., 1995; Silvestri, Pritchard, &
Welch, 1998). Effects on QOL
should, therefore, be considered in
conjunction with the survival
advantages of different treatments. Utility assessment takes
both of these factors into account
in computing quality-adjusted
survival (Kattan, 2003). However,
the effect of hot flashes on overall
QOL, as measured by utility, is
unknown. Studies are needed to
address this issue.
Additional Methods Are
Needed for Men with
Prostate Cancer
Few scientific investigations
have studied objective measures
of hot flashes in men with
prostate cancer. One such measure was evaluated approximately 20 years ago with a sample of
13 men who had undergone
orchiectomy for prostate cancer.
A laser Doppler flowmeter and
evaporometer were used to
assess skin blood flow and water
evaporation. Results demonstrat-
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ed that the rate of water evaporation increased by 10 to >60
g/m2/h in approximately 65% of
patients experiencing hot flashes.
Moreover, increased evaporation
was synchronous with increased
cutaneous blood flow (Frödin et
al., 1985). Although objective
measures may be useful in this
patient population, some investigators believe that the patient’s
subjective experience and opinion are more important determinants of symptom severity and
that the patient’s opinion should
take precedence over an objective skin temperature reading
(Sloan et al., 2001). Furthermore,
the correlation between skin conductance measures and selfreported hot flashes is lower in
the ambulatory setting than in
the laboratory because of underreporting of self-reported hot
flashes, and there are physical
limitations associated with the
use of sternal skin conductance
monitors that prohibit their longterm use in the ambulatory setting (Miller & Li, 2004).
There is a clear need for
additional methods of evaluating
hot flashes in men receiving
androgen ablation therapy.
Because hot flashes described in
men on androgen ablation therapy are similar to those described
in menopausal women and
breast cancer survivors, it may be
useful to explore the methods of
evaluating hot flashes in these
patients to determine their utility
in men.
Measures of Hot Flashes
In Menopausal Women
And Breast Cancer Survivors
In pre-menopausal women
with breast cancer, chemotherapy can precipitate menopause
and lead to the rapid onset of hot
flashes. Furthermore, more than
50% of patients treated with
tamoxifen (an anti-estrogen
agent) develop hot flashes (Hoda,
Perez, & Loprinzi, 2003). The
severity of hot flashes in breast
cancer survivors varies and has
16
Table 1.
Components of the Hot Flash Related Daily Interference
Scale (HFRDIS)*
•
•
•
•
•
•
•
•
•
•
Work (outside the home and housework)
Social activities (time spent with family, friends, etc.)
Leisure activities (time spent relaxing, doing hobbies, etc.)
Sleep
Mood
Concentration
Relationship to others
Sexuality
Enjoyment of life
Overall quality of life
* Items are rated on a scale from 0 (does not interfere) to 10 (completely
interferes).
Source: Carpenter, 2001
been described as mild or
uncomfortable in some and as
boiling eruptions in others
(Finck, Barton, Loprinzi, Quella,
& Sloan, 1998). In postmenopausal women with breast
cancer, hot flashes have been correlated with poorer sleep quality,
more fatigue, and worse physical
health (Stein, Jacobsen, Hann,
Greenberg, & Lyman, 2000). In a
study that compared postmenopausal women with and
without hot flashes, those with
hot flashes experienced 66%
more fatigue, 63% poorer sleep
quality, and 20% poorer health
(Stein et al., 2000).
Trials that evaluated treatment of hot flashes in breast cancer survivors used patient
diaries, daily logs, and questionnaires (Barton et al., 1998; Barton
et al., 2002a; Loprinzi et al.,
2002a; Loprinzi et al., 2002b).
Many of these tools are similar to
those that have been used in
studies of hormone ablation therapy. However, in women, a QOL
instrument has been developed
exclusively to assess the impact
of hot flashes on daily activities
and overall QOL; the Hot Flash
Related Daily Interference Scale
(HFRDIS) is a psychometrically
sound instrument that has been
evaluated in breast cancer survivors (see Table 1) (Carpenter,
2001). The HFRDIS was used to
analyze the impact of hot flashes
on overall QOL and daily activities, including work, social activities, leisure activities, sleep,
mood, concentration, relationships with others, sexuality, and
enjoyment of life by rating the
impact of hot flashes on a scale
from 0 (do not interfere) to 10
(completely interfere). When this
instrument scale was tested in
breast cancer survivors and agematched healthy controls, it
exhibited high internal consistency and validity. Frequency,
severity, and bother (for example,
distress) were more important
determinants of the impact of hot
flashes on daily activities than
the duration of hot flashes. Hot
flashes interfered most with
sleep, mood, and concentration
(Carpenter, 2001). Interestingly,
every item on the HFRDIS was
affected by hot flashes. Although
the HFRDIS was used to evaluate
hot flashes in women, it is not a
gender-specific tool. Thus, this
tool may be considered for use in
the clinical setting when assessment of hot flashes in females or
males is desired.
A number of studies suggest
that hot flashes in menopausal
women can be objectively evaluated using various objective measures such as sternal skin con-
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ductance or skin conductance
changes in combination with circulation changes (deBakker &
Everaerd, 1996; Freedman, 1989;
Freedman, Norton, Woodward, &
Cornelissen, 1995; Freedman,
Woodward, & Norton, 1992;
Swartzman, Edelberg, & Kemmann,
1990; Tataryn et al., 1981).
However, changes in skin temperature are not always correlated
with subjective assessments of hot
flashes (Tataryn et al., 1981).
Furthermore, sternal skin conductance pattern changes do not
explain variations among subjectively experienced hot flashes,
and the perception of bodily sensations is less accurate under
experimental versus real-world
conditions (deBakker & Everaerd,
1996; Pennebaker & Roberts,
1992, as cited in deBakker &
Everaerd, 1996). Since objective
techniques have been evaluated
only in small studies, their relative validity for hot flash measurements is questionable.
Conclusion
Hot flashes are one of the
most common side effects of
androgen ablation treatment in
men with prostate cancer. Their
incidence in these patients is not
self-limiting, and they can be
incapacitating if severe. Thus,
reliable subjective and objective
evaluation tools are needed to
determine the impact of hot
flashes on daily functioning in
patients who receive androgen
suppression therapy. Information
collected from patient diaries,
charts, and questionnaires can be
used to make subjective assessments of symptoms, but the
reliability of these sources is often
questionable. The currently available objective methods for evaluating symptoms do not accurately
reflect the subjective experiences
of patients with hot flashes. The
feasibility of using a symptomspecific QOL tool such as the
HFRDIS to evaluate hot flashes in
men should be investigated.
Moreover, additional instruments
should be developed and validated to gain a better insight into the
QOL effects of hot flashes in men
with prostate cancer who are
receiving androgen ablation therapy. •
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CE test can be found
on page 21
SUNA’s Mission
The Society of Urologic
Nurses and Associates, Inc.
is a professional organization committed to excellence
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and a continuum of quality
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UROLOGIC NURSING / February 2006 / Volume 26 Number 1