Intraoperative Electrical Stimulation of the Acupoint P6 to Prevent Post-Operative Nausea and Vomiting in Women Undergoing Breast Cancer Surgery
Phase: NA
Conditions: Post-Operative Nausea and Vomiting, Breast Cancer
Sponsor: M.D. Anderson Cancer Center

2 0 1 5 -0 1 7 0  
R e v ise d  3 /2 1 /1 8 
P a g e  1  o f 1 2  
Titl e of  St u d y: I ntr a o p er ati v e el e ctri c al sti m ul ati o n of  t h e a c u p oi nt P 6  t o pr e v e nt p o st- o p er ati v e n a u s e a 
a n d v o miti n g i n w o m e n u n d er g oi n g br e a st s ur g er y 
I n v e sti g at or s: Ali ci a K o w al s ki, J e n nif er M c Q u a d e, L or e n z o C o h e n, K a y G ar ci a, Eli z a b et h R e b ell o, S p e n c er 
K e e, F ar zi n G or a v a n c hi, K at y Fr e n c h, I a n Li p s ki , J o s e p h C hi a n g, Mi n xi n g C h e n, Yi s h e n g Li  
St u d y C e nt er s: D e p art m e nt of A n e st h e si a a n d P eri- o p er ati v e M e di ci n e a n d I nt e gr ati v e M e di ci n e Pr o gr a m, 
D e p art m e nt of  G e n er al O n c ol o g y, U. T. M D  A n d er s o n C a n c er C e nt er, H o u st o n, T X  
1. 0 S p e cifi c Ai m s  
P o st- o p er ati v e n a u s e a a n d v o miti n g ( P O N V) i s a c o m m o n pr o bl e m t h at si g nifi c a ntl y i m p a ct s p ati e nt c o mf ort 
a n d  s ati sf a cti o n a n d  c a n d el a y di s c h ar g e. T h e br e a st s ur g er y p o p ul ati o n i s e s p e ci all y at  ri s k f or P O N V, gi v e n 
t h at 2 of t h e l e a di n g ri s k f a ct or s f or P O N V, f e m al e g e n d er a n d u s e of p eri- o p er ati v e n ar c oti c s, ar e n e arl y 
u ni v er s al. W hil e t h e u s e of pr o p h yl a cti c a nti- e m eti c s si g nifi c a ntl y r e d u c e s t h e i n ci d e n c e of P O N V, it still 
r e m ai n s a si g nifi c a nt pr o bl e m, e s p e ci all y a m o n g hi g h ri s k p ati e nt s (i. e., t h o s e wit h a hi st or y of  P O N V or  m oti o n 
si c k n e s s). Sti m ul ati o n of  t h e a c u p oi nt P eri c ar di u m 6 ( P 6) h a s b e e n  d e m o n str at e d t o b e  eff e cti v e at  b ot h 
pr e v e nti n g a n d  tr e ati n g n a u s e a a n d  v o miti n g i n m ulti pl e s etti n g s a n d  h a s  s p e cifi c all y b e e n  d e m o n str at e d t o b e  
a s  eff e cti v e a s  p h ar m a c ol o gi c al a nti- e m eti c s i n P O N V.[ 1] H o w e v er, t h e r ol e of  P 6  a s  a n  a dj u n ct t o m ulti- a g e nt 
pr o p h yl a xi s i s l e s s cl e ar. P 6 sti m ul ati o n c a n b e a c c o m pli s h e d t hr o u g h n e e dl e i n s erti o n, a c u pr e s s ur e, or 
el e ctri c al sti m ul ati o n. R e c e ntl y, t w o r a n d o mi z e d tri al s i n E ur o p e a n d A si a h a v e r e p ort e d p o siti v e r e s ult s i n 
P O N V pr e v e nti o n u si n g i ntr a- o p er ati v e el e ctri c al sti m ul ati o n of P 6 wit h a n e ur o m u s c ul ar bl o c k a d e m o nit or 
( N M B M).[ 2, 3]  T h e a d v a nt a g e t o t hi s m et h o d i s t h at it e m pl o y s a st a n d ar d a n e st h e si a t o ol, a n d,  b e y o n d 
a n e st h e si ol o gi st tr ai ni n g o n  P 6  p oi nt l o c ati o n, r eq uir e s n o  a d diti o n al r e s o ur c e s f or i m pl e m e nt ati o n. H o w e v er, 
b ot h of  t h e s e tri al s c o m p ar e d N M B M t o n o pr o p h yl a xi s r at h er t h a n a s a n  a dj u n ct t o p h ar m a c ol o gi c al 
pr o p h yl a xi s. W e r e c e ntl y pr e s e nt e d a s m all c a s e s eri e s i n w hi c h w e e m pl o y e d i ntr a o p er ati v e N M B M 
sti m ul ati o n of  P 6  al o n g wit h p h ar m a c ol o gi c al pr o p h yl a xi s i n p ati e nt s wit h a hi st or y of  P O N V ( d e s pit e pr e vi o u s 
p h ar m a c ol o gi c al i nt er v e nti o n) a n d f o u n d t h at n o n e  of  t h e s e p ati e nt s d e v el o p e d P O N V wit h t h e c o m bi n e d 
tr e at m e nt m o d aliti e s.[ 4] 
T h e pr o p o s e d t w o- ar m, r a n d o mi z e d, d o u bl e- bli n d ( p ati e nt a n d  a s s e s s or), c o ntr oll e d st u d y will d et er mi n e t h e 
i niti al effi c a c y a n d  f e a si bilit y of  a n e st h e si ol o gi st- pr o vi d e d i ntr a o p er ati v e N M B M el e ctri c al sti m ul ati o n of  P 6  
c o m bi n e d wit h pr o p h yl a cti c a nti- e m eti c s v er s u s p h ar m a c ol o gi c al pr o p h yl a xi s al o n e i n w o m e n at  hi g h-ri s k f or 
P O N V u n d er g oi n g br e a st s ur g er y. T hi s st u d y will pr o vi d e pr eli mi n ar y e vi d e n c e of  effi c a c y t o i nf or m t h e d e si g n 
of  a l ar g er m ulti-i n stit uti o n al tri al. W e  will al s o e x pl or e pr e di ct or s of  r e s p o n s e t o P 6  sti m ul ati o n i n cl u di n g 
g e n eti c p ol y m or p hi s m s a n d e x p e ct a n c y. T h e ai m s of  t h e pr o p o s e d st u d y ar e t o: 
P RI M A R Y AI M: 
1. E x a mi n e t h e effi c a c y of el e ctri c al sti m ul ati o n of P 6 c o m bi n e d wit h pr o p h yl a cti c a nti- e m eti c s v er s u s
p h ar m a c ol o gi c al pr o p h yl a xi s al o n e i n pr e v e nti n g t h e i n ci d e n c e of P O N V f oll o wi n g br e a st s ur g er y i n
p ati e nt s at hi g h-ri s k f or P O N V. 
S E C O N D A R Y AI M S: 
1.
D et er mi n e t h e st u d y f e a si bilit y a n d eff e ct s o n  s e v erit y of  P O N V of  a n e st h e si ol o gi st- pr o vi d e d
i ntr a o p er ati v e N M B M el e ctri c al sti m ul ati o n of  P 6  c o m bi n e d wit h pr o p h yl a cti c a nti- e m eti c s i n w o m e n at
hi g h-ri s k f or P O N V u n d er g oi n g br e a st s ur g er y.
2.
E x a mi n e t h e eff e ct s of i ntr a- o p er ati v e N M B M sti m ul ati o n of P 6 o n n e e d f or r e s c u e a nti- e m eti c s
c o m p ar e d t o t h e c o ntr ol gr o u p.
Pr o pri et ar y I nf or m ati o n of M D A n d er s o n

2015-0170
Revised 3/21/18 
Page 2 of 12
  
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Proprietary Information of MD Anderson

2015-0170
Revised 3/21/18 
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1.
Vickers, A.J., Can acupuncture have specific effects on health? A systematic review of acupuncture antiemesis 
trials. J R Soc Med, 1996. 89(6): p.303-11. 
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