Breast Cancer Clinical Trial
Official title:
An Assessor-Blinded, Randomised Controlled Trial of Acupuncture to Prevent Chemobrain in Breast Cancer Patients
Chemobrain is an expression used to describe a cluster of chemotherapy-induced cognitive
impairment symptoms, including problems with visual and verbal memory, forgetfulness,
difficulty in learning, attention, concentration and coordination of multitasking and
organization. Over 75% cancer patients experienced acute cognitive symptoms during
chemotherapy and 17%-34% of them have long-term post-treatment cognitive deficits which can
persist up to 10 years. Breast cancer survivors even display as high as 50%-75% prevalence of
post-treatment cognitive impairment. Chemobrain has become an apparent quality-of-life issue
for cancer survivors and will be encountered more frequently with the rise of the number of
cancer survivors. There are no effective interventions available for preventing and treating
chemobrain.
Acupuncture is beneficial in reducing various side effects of anti-cancer treatment. It also
shows the efficacy in improving mild cognitive impairment and other dementia disorders;
facilitates the recovery of pathological microstructural changes of the brain. These results
have led to the hypothesis that acupuncture is effective in preventing chemobrain and this
preventive effect may be associated with the protection against cytokine production,
epigenetic modification and microstructural changes of the brain.
To test this hypothesis, an assessor-blinded, randomised controlled trial will be conducted
to determine if a combination of DCEAS and body acupuncture could reduce the incidence and
symptoms of chemobrain in breast cancer patients under chemotherapy compared to least
acupuncture stimulation (LAS) as controls.
A total of 168 breast cancer patients who are ready for chemotherapy will be randomly
assigned to comprehensive acupuncture intervention (combined DCEAS and body acupuncture
regimen + chemotherapy) (CAI) (n = 84) for 2 sessions per week for 8 weeks or least
acupuncture stimulation (LAS) (minimal acupuncture + chemotherapy) (n = 84). All patients
receive the standard chemotherapy of breast cancer. Treatment outcomes on cognitive
performance, fatigue and the depression will be assessed.
Although the development of various chemotherapeutic drugs has greatly improved clinical
outcomes and survival rate of cancer patients, it also causes various adverse side effects.
Chemotherapy-induced cognitive impairment, often referred to as chemobrain, has drawn
increasing attention due to the rise in the number of cancer survivors over the past decade.
Numerous studies have shown that chemotherapy can cause acute and long-term post-treatment
cognitive impairment, including problems with visual and verbal memory, forgetfulness,
difficulty in learning, attention, concentration and coordination of multitasking and
organization. Over 75% cancer patients reported to experience acute cognitive symptoms during
chemotherapy and 17%-34% of them have long-term post-treatment cognitive deficits which can
persist up to 10 years. Breast cancer survivors may display higher prevalence of
post-treatment cognitive impairment. The severity of reported chemobrain symptoms is
variable, from subtle to more severe. Chemobrain has become an apparent quality-of-life issue
for survivors and will be encountered more frequency in the future. However, there are no
effective interventions available to prevent and treat chemobrain, although some
pharmacological, antioxidant and various cognitive approaches have been tested.
It is believed that chemobrain is a consequence of brain neuronal injury induced by
systemically administered chemotherapeutic agents via direct and indirect mechanisms,
resulting in the suppression of neuronal cell proliferation, epigenetic modification and
microstructural changes of the brain. These pathological circumstances are largely developed
from alternations in cytokine milieu. While physical and psychological stressors that cancer
patients experienced after diagnosis, chemotherapy and long-term follow-up have been shown to
increase circulating cytokine levels and increased cytokine levels are associated with
cognitive decline in cancer patients, the administration of chemotherapy also results in
cytokine production at peripheral and central levels as the medications induce tumor cell
death and collateral tissue injury. Patients undergoing chemotherapy have been found to
display significant increases in multiple cytokines.
A large body of evidence well confirms that acupuncture is effective in reducing anti-cancer
treatment-caused side effects, including pain, nausea, hot flashes, fatigue, xerostomia,
anxiety, depression and sleep disturbance. Numerous studies further have shown the
effectiveness of acupuncture therapy in improving cognitive function of patients with mild
cognitive impairment (MCI) and various dementia. The reduced severity of cognitive symptoms
is associated with neuroimaging improvement in brain regions associated with learning and
memory process. Acupuncture also ameliorates cognitive impairment in various animal models.
Studies have further revealed that the cognition-improving effects of acupuncture are
associated with the inhibition of cytokine-mediated neuronal cell apoptosis, inflammatory
reaction and oxidative cellular injury and the effects in reducing cognitive symptoms are
related to the protection of neuronal cells, improvement of electrophysiological activities
of the hippocampus and brain cell proliferation. Moreover, acupuncture also displays a
significant effect in facilitating the recovery of the brain at microstructural
histopathological level in patients with cerebral infarction and in rats with transient focal
cerebral ischemia. The investigators therefore hypothesize that acupuncture may be also
effective in preventing and reducing chemotherapy caused cognitive impairment.
Recently, the investigators have developed a novel acupuncture stimulation called dense
cranial electroacupuncture stimulation (DCEAS) on the basis of neuroanatomical rationale. In
this mode, electrical stimulation is delivered on dense acupoints located on the forehead
innervated by the trigeminal nerve. The trigeminal sensory pathway has much intimate fiber
connections with brain regions associated with sensory, locomotor, visceral function, sleep,
emotion, learning and memory. Therefore, DCEAS can effectively modulate brain functions. Over
the past 5 years, the investigators have completed several clinical studies and demonstrated
the benefits of DCEAS in the treatment of major depression, insomnia, OCD, postpartum
depression and post-stroke depression. In the proposed study, a combination of DCEAS and body
acupuncture will be employed to prevent and treat chemobrain in breast cancer patients.
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