1. Double-Blinded, Sham-Controlled, Pilot Study of Acupuncture and its Effectiveness Towards
Rebuilding White Blood Cell Count (WBCC) in Post-Chemotherapy Cervical Cancer Patients
By: Alissa Calderon
Bridges to the Baccalaureate
San Diego State University

2. Introduction:
Past pilot studies have proven that acupuncture is capable of relieving various post-
chemotherapy symptoms including fatigue, nausea, xerostomia, and leukopenia for various
forms of cancer 3,6,7. In my study, I will be focusing on leukopenia (white blood cell deficiency)
in cervical cancer patients and will be comparing the effectiveness of acupuncture with that of
the standard drug Neupogen in rebuilding white blood cell count.
Chemotherapy drugs kill both cancerous and non-cancerous cells during treatment that
ultimately result in a significantly weakened immunity among cancer patients. In comparison to
a healthy human white blood cell count (WBC) of well over 4.0K/mcL, a cancer patient’s WBC
falls to less than 3.0 K/mcL after chemotherapy 3. Without the sufficient amount of leukocytes
(WBC), the body is unable to recover as quickly nor as well, making the body more vulnerable
to additional chemotherapy and its side effects 3. White blood cells are vital to combating toxins
and in repairing our bodies. Without their vital support (if there isn’t enough in the bloodstream),
patients become progressively weaker with every chemotherapy cycle.
To rebuild WBC, oncologists often administer a class of drugs called Colony Stimulating
Factors (CSF) as an injection3. In this class, there are three different subgroups of CSFs: CSF,
Granulocyte CSF (G-CSF), and Granulocyte Macrophage CSF (GM-CSF) 3. In this experiment,
we will be using a G-CSF drug that is typically administered for chemotherapy patients 3.
Though they produce positive results, the downside to these drugs is that they are very expensive
to develop and they also have their own set of debilitating side effects 3. The G-CSF that will be
used is called Neupogen that will be injected into the patients thigh. Side effects of Neupogen
and other CSF-class drugs include musculoskeletal pain, fever, dizziness, fatigue, constipation,
diarrhea, and difficulty breathing.

3. With that said, it is a priority to provide not only provide the relief that cancer patients
need but also in the least harmful way possible. Acupuncture will be the alternative method that
will be tested in this experiment and it will be tested in three different variations: regular
acupuncture, sham acupuncture, and electro-acupuncture. Regular acupuncture is the standard
application of needles at key points on the body for therapeutic purposes. Electro-acupuncture is
the same procedure except that the needles are hooked to an electrical power source that
stimulates these points.
Although acupuncture has been known to treat various conditions and has been used for
thousands of years, critics of alternative medicine call acupuncture a placebo effect rather than a
genuine phenomenon 4. To combat this assumption, an extra variable group has been added to
this study – sham acupuncture. This procedure is almost identical to standard acupuncture except
that the needles are relatively 1-2 cm away from the actual acupuncture point. It is not a priority
to identify acupuncture as a placebo method however, if it does prove more effective, it would
nullify the primary argument of acupuncture non-believers.
Acupuncture has been confirmed to be beneficial in a wide variety of conditions both
related and unrelated to cancer, in surgical settings, as a pain reliever, and a stress/emotional
stabilizer. Relatable to my topic is electro-acupuncture’s effectiveness towards improving blood
circulation and in nourishing the blood 1,2. Studies have shown that acupuncture was capable of
stimulating the bone marrow to produce more blood and, at keys points, increase the blood flow
throughout the body. White blood cell count is no exception especially as a post-chemotherapy
symptom which is what inspired this experiment and my hypothesis. This experiment will show
that electro-acupuncture is more effective than the Neupogen and the other acupuncture methods
in rebuilding WBC in cervical cancer patients.

4. Study Design:
Materials
The following materials will are required for this study (though the hospital may provide for the
majority of our supplies):
 4200 - SEIRIN 0.20x30mm, stainless steel, disposable, SJ10 acupuncture needles
 1 - ITO ES-160 electrotherapy device1,2
 Vacutainer Push Button Blood Collection Set
 1200 - Blood Collection Tubes
o 13 X 100 size, 7 mL draw
o serum tube, no additives, silicone-coated
 1 - Blood Analyzer (Differential White Blood Cell Counter) 1,2
o PROKAN Hematology Analyzer
 3 acupuncturists
 2 oncologists
 5 nurses
 5 lab technicians
 47 – 300 mcg vials of Neupogen

5. Budget
Prices Supplies Notes
$680.40
(42 needles/person,
150 patients,
$10.80/box of 100)
6300 - SEIRIN
acupuncture needles
0.20x30mm
stainless steel
disposable
SJ10 type acupuncture
needles
$768.00 ITO ES-160
electrotherapy device
$2,878.32
[$119.93/box of 50,
1200 total (200
patients x 6 blood
samples)]
Vacutainer Push Button
Blood Collection Set
$365.04
($30.42/ box of 100)
1200 - Blood Collection
Tubes
13x100 size
7 mL draw
serum tube
no additives
silicone coated on the
inside
$5,000/set 1- Blood Analyzer
(Differential White
Blood Cell Counter)
PROKAN Hematology
Analyzer
$5769.24
(2 weeks pay for 3
acupuncturists)
3 acupuncturists $961.54/week
$23,076.92
(2 weeks pay for 2
oncologists)
2 oncologists $5769.23/week
$12,440.38
(2 weeks pay for 5
nurses)
5 nurses $1244.04/week
$8976.92
(2 weeks pay for 5
lab techs)
5 lab technicians $897.69/week
$14,100
($300/ 300mcg vial)
47 - 300mcg vials of
Neupogen
$10,000
(2 weeks pay for
myself)
Me $5000/week
Total: $84,055.22
Methods

6. I. Patients
Before beginning the study, the informed consent of 200 cancer patients must be collected.
These women must have recurring cervical cancer; between the ages of 18-65 years old; must
not have other serious medical conditions other than cancer; and must have a 2 week
recovery gap between chemotherapy cycles. They will all be informed of the study’s
protocol, risks involved with taking Neupogen, materials used in the experiment, the blood
collection protocol and tests that will be run on their samples. Once their informed consent is
received, then the study can begin. The patients will be randomly placed into any of the four
groups as shown below. There will be 50 patients in each group and patients will be blind to
each other and (for acupuncture groups only) they will be blind to which acupuncture
treatment they will be receiving.
II. Staff
The acupuncturists hired will each be assigned to either of the three acupuncture groups but
as a prerequisite, they must have at least ten years of acupuncture experience; must have the
required license to practice; and must be knowledgeable and skillful in acupuncture, sham
acupuncture, and electro-acupuncture. They will initially be blind to the identities of the
participants but upon their first acupuncture session, they will be unblended. However, they
200 cervicalcancer
patients
Control Group:
Neupogen Only (50
patients)
Acupuncture and
Neupogen (50
patients)
Sham Acupuncture
and Neupogen (50
patients)
Electro-acupuncture
and Neupogen (50
patients)

7. will be blind to the patients’ blood test results. The oncologists involved in the study must
have a minimum of ten years in field specialization of oncology and will be blind to the
participants blood test results and to which treatment group the participants are assigned to.
Lab technicians must have a minimum of five years of work experience from their time of
receiving their certification and nurses participating in the experiment must have a minimum
of five years experience in the field of oncology. Nurses must be knowledgeable of the G-
CSF drug Neupogen and the injection sites for which this drug is to be administered. Lab
technicians must have certification in phlebotomy and blood analysis equipment such as the
kind used in this experiment.
III.Blood Collection/Analysis Protocol
On the last day of their second cycle of chemotherapy, lab technicians will collect the
participants’ initial blood samples to calculate the participants’ initial WBC count. Blood will
be extracted from the vein at the inner left elbow. 3.0 mL of blood will be drawn at each
sample collection. Blood samples will be collected on the last day of the 2nd chemo cycle
(Day 1), every third day after that for two weeks and on the final day (Day 14). For example:
Blood Sample Collection Schedule
Sunday Monday Tuesday Wednesd
ay
Thursday Friday Saturday
Day 1: Last
day of
chemo.
Initial blood
collection
(#1)
Day 2:
Neupogen
and/or
acupuncture
begin
Day 3: Day 4:
Blood
sample #2
Day 5: Day 6: Day 7:
Blood
sample #3
Day 8: Day 9: Day 10:
Blood
sample #4
Day 11: Day 12:
Blood
Sample #5
Day 13: Day 14:
Final blood
sample (#6)

8. The participants’ samples will be analyzed by lab technicians using the Hematology
Analyzer equipment provided to solely determine white blood cell count. The only people
with access to the data will be the lab technicians and myself. With the data collected, I
would compile charts and tables so as to identify the white blood cell count trends among the
four test groups.
IV. Acupuncture/Neupogen Protocol
Should blood samples be scheduled to be collected on a given day, then that will be
performed first before both the Neupogen and the acupuncture treatment. Everyday,
Neupogen will be administered first by a registered nurse via injection at the specified
injection site (the top portion of the left thigh). All participants will receive 5.0 mcg/kg daily
throughout the study. After the Neupogen injections, the acupuncture groups will undergo
their 45-minute sessions with their assigned acupuncturist. Three of the following
acupuncture points will be tested in this experiment:
1) Zu San Li – Stomach Meridian (ST) #36
2) San Yin Jiao – Spleen Meridian (SP) #6
3) He Gu – Large Intestine Meridian (LI) #4
V. Test Results
When test results will be compiled and finalized, they will be disclosed to the participants
and they will un-blinded from which treatment they had undergone those past two weeks.
Their oncologists will receive their test results as well. Nurses and lab technicians will
remain blind to the participants’ information even after the study’s conclusion.

9. References
[1] Ishikawa, Shintaro, M. Murai, T. Sato, M. Sunagawa, E. Tokita, S. Aung, K. Asano, T.
Hisamitsu. Promotion of Blood Fluidity by Inhibition of Platelet Adhesion Using
Electroacupuncture Stimulation. Journal of Acupuncture and Meridian Studies (2011) 4:
44-53
[2] Ishikawa, Shintaro, H. Suga, M. Fukushima, A. Yoshida, Y. Yoshida, M. Sunagawa, T.
Hisamitsu. Blood Fluidity Enhancement by Electrical Acupuncture Stimulation is Related
to an Adrenergic Mechanism. Journal of Acupuncture and Meridian Studies (2012) 5:
21-28.
[3] Liu Ping, L. Yang, T. Qiang. Acupoint Injection plus Moxibustion on Post-Chemotherapy
Leukopenia. Shanghai Research Institute of Acupuncture and Meridian (2006): 87-89.
[4] Norheim, A.J., V. Fonnebo. Attitudes to the Contribution of Placebo in Acupuncture – a
survey. Complementary Therapies in Medicine (2002) 10: 202-209.
[5] Regan, David, J. Filshie. Acupuncture and Cancer. Autonomic Neuroscience: Basic and
Clinical (2006): 96-100.
[6] Sagar, Stephen M. Acupuncture as an Evidence Based Options for Symptoms Control in
Cancer Patients. Complementary and Alternative Options in Oncology (2008): 117-126.
[7] Stone, Jennifer, P. Johnstone. Mechanisms of Action for Acupuncture in the Oncology
Setting. Current Treatment Options for Oncology (2010) 11: 118-127.