Transcript Overview - MD Anderson

Integrative Oncology Trials
Lorenzo Cohen, PhD
Director, Integrative Medicine Program
CAM Use in Oncology
(Asking Patients about CAM Use)
Patricia Parker, Lorenzo Cohen,
Neby Bekele, Jan Pickett, Holly Hough
The University of Texas M. D. Anderson Cancer Center
Division of Cancer Medicine
Community Clinical Oncology Program Research Base
What CIM methods do
patients with cancer use?
Biologically-based
Practices
Mind-Body Medicine
Manipulative and
Body-Based Practices
Whole Medical Systems
Energy Medicine
CAM Users Versus Nonusers
CLINIC
PATIENTS
CAM
USERS
# patients
%
Breast Clinic
250
129
51.6
GYN Clinic
250
112
44.8
Navo et al., 2004
Reasons for Using CAM

To improve overall health.

To reduce adverse drug reactions and/or improve
quality of life.

To boost the immune system.

A minority endorse to treat cancer.
Percent of patients who
have not discussed CIM
with their doctor
DK/NR
1%
Yes
22%
Why patients have not
discussed CIM with their
doctor
Doctor would have been
dismissive or told you
not to do it
12%
Don't think doctor knows
the topic
17%
Not enough time during
office visit
19%
Didn't know they should
30%
Doctor never asked
42%
No 77%
Oncology Nurses and Communicating
with Patients about CAM

National survey of 850 registered nurses
involved in direct patient care in oncology
settings.

Nurses reported that initiated conversations
about CAM use were rare.
Rojas-Cooley and Grant, 2006
Study Objectives

Primary:

Examine efficacy of an educational intervention designed to increase
the frequency with which oncology nurses ask their patients about
CAM use.
Secondary:

Examine frequency of CAM use and referral for CAM use in oncology
nurses.

Evaluate whether personal use among oncology nurses is related to
frequency of asking patients about CAM.

Assess the frequency and type of CAM use among patients
diagnosed with cancer.
Participants

Oncology nurses at participating CCOP
component sites.

Oncology patients of participating providers (4
per provider).
Study Design
Baseline Patient Assessment
Random Assignment to
Intervention or Control
Baseline Provider
Assessment
Baseline Provider
Assessment
Video and Resource List
2 months
Provider and Patient
Follow-Up Assessment
Provider and Patient
Follow-Up Assessment
Video and Resource List
Progress

185 patients

8 sites registered
A Phase III Prospective Randomized
Trial of Acupuncture for Treatment
of Radiation-Induced Xerostomia in
Patients with Head and Neck Cancer
Joseph Chiang, Mark Chambers, Kay Garcia, Lynn
Palmer, Lorenzo Cohen
Background and Significance

70-80% of head/neck cancer patients
receive radiation

IMRT can reduce physical damage to
major salivary glands
- Xerostomia still a problem with IMRT
Radiation Treatment and Xerostomia

Salivary dysfunction

Related to dose, time, location and
volume of tissue radiated

Develop early in therapy and worsens
over time

Partially reversible (at <50Gy)
Acupuncture and Xerostomia

Acupuncture can stimulate saliva flow

Xerostomia relief with as few as 5-10
treatments

Benefits lasting up to 3 years posttreatment in one study
Xerostomia
37
35
XI
33
31
29
27
25
baseline
1
2
3
4
5
8
Weeks
Garcia et al., Head & Neck, In Press
Xerostomia Questionnaire
Acupuncture
70
60
*
*
(p=0.0005)
*
50
Level
*
Control
(p=0.002)
*
40
30
*
20
*
10
0
0
1
2
3
4
5
6
7
Treatment Week
8
9
10
11
12
MDASI-Symptoms (12 items)
Acupuncture
MDASI-Symptoms (13 items)
Acupuncture
Control
35
40
30
35
Control
†
†
30
25
25
20
15
10
10
5
5
0
0
0
1
2
3
4
5
6
7
8
9
10
11
MDASI-H&N
Acupuncture
40
35
†
*
20
†
15
0
12
1
2
3
4
5
6
7
8
9
10
11
12
MDASI-Interference
† (p<0.10)
* (p<0.05)
Acupuncture
Control
Control
30
* *
* *
25
30
20
25
20
15
*
15
*
10
10
5
5
0
0
0
1
2
3
4
5
6
7
8
9
10
11
12
0
1
2
3
4
5
6
7
8
9
10
11
12
Saliva production in Acupuncture
and Control patients
8
Acpuncture (us)
Acupuncture (s)
Control (us)
Control (s)
7
Saliva weight
6
5
4
3
(p=0.0006)
*
*
2
**
(p=0.005)
**
1
(p=0.007)
0
0
1
2
3
4
5
6
7
8
Week
(p=0.005)
9
10
11
12
Collected
before acu tx
* (p<0.05)
**(p<0.01)
Objectives

To determine whether or not acupuncture
can symptomatically improve severe
xerostomia due to head/neck
radiotherapy.

To explore the duration of response (up to
a maximum of 12 weeks) in the subgroup
of patients who report a response to the
acupuncture intervention.
Inclusion Criteria
Patients with head/neck cancer who have received bilateral radiation
therapy and who subsequently developed xerostomia.
Grade 2 or 3 xerostomia, according to RTOG scale.
Nine months after completing radiotherapy.
No history of xerostomia prior to the head/neck radiation therapy.
No local infection at or near the acupuncture site or active infection.
Exclusion Criteria:
Patients on or planned to receive another xerostomia treatment agent.
All agents known to treat xerostomia should be stopped at least 14 days
prior to enrollment.
Acupuncture

The acupuncture points will be at three
sites on each ear, a site on the chin, a site
on each forearm, a site on each hand, a
site on each leg, and one placebo needle
at Gb32 for a total of 14 sites. All sites will
be applied for 20 minutes.
Sham Group (inactive acupuncture)






Sham Location 1 - placebo needle at inactive point located 0.5 cun below
and 0.5 cun lateral to CV 24 on the chin
Sham Location 2 - placebo needle at inactive point located 0.5 cun radial
and 0.5 cun proximal to SJ 6 between SJ and LI Channels (bilateral UE)
Sham Location 3 - placebo needle at inactive point located 2 cun above
Sham Location 2 between SJ and LI Channels and between LI7 and LI8
(bilateral UE)
Sham Location 4 - placebo needle at inactive point located 1.0 cun below
and 0.5 cun lateral to St 36, between St and Gb Channels (bilateral LE)
One 32 gauge x 30mm acupuncture needle at GB32 above the right knee
(Note: This point is not indicated for dry mouth and is used to elicit de qi
sensation in the control group.)
Three 40 gauge x 15mm acupuncture needles on the helix of each ear (6
points total). Location of inactive points will be confirmed with an
electrodermal point finder.
Chemotherapy and Mindfulness
Relaxation: a Randomized Trial
Jon Hunter, Lorenzo Cohen, Laszlo Radvanyi,
Peter Mueller
MDACC CCC-01-06
Side Effects
Cytotoxic

Nausea and vomiting

Alopecia

Immunosuppression

Anorexia

Stomatitis

Diarrhea
Side Effects
Conditioned

Nausea, Vomiting

Anxiety

Immunosuppression

Fatigue (?)
Interventions - General

Cognitive/behavioral therapy

relaxation

guided imagery

biofeedback

progressive muscle relaxation

hypnosis

group and individual intervention
Interventions – Nausea and
Vomiting

guided imagery

systematic desensitization

hypnosis

progressive muscle relaxation
Outcomes

Treatment and disease related symptoms

Emotional adjustment

Functional adjustment

Immune function

Medical outcomes (chemotherapy dose)

Survival?
Therapeutic Barriers

Not easily applicable to varied settings or
illnesses

Typically administered by a trained mental
health professional

Labor intensive and costly
Attributes of an “Ideal” Intervention

Pre-emptive

Brief

Utilizes available personnel

Integrated into standard care

Amplifies therapeutic relationship with treatment team

Not burdensome for patient

Generalizable
 to
any clinic
 to
any patient
 to
any stress
Intervention
-Mindfulness Relaxation
Self-hypnosis

Guided imagery

Yoga breathing

Mindful attitude
Mindfulness Relaxation Delivery

15-20 minute script

first contact requires ~ 60 minutes

nurse provides brief educational session
(maybe integrated into typical chemotherapy
education)

runs patient through one training session
 ‘troubleshoots” any problems, offers
encouragement
….
Mindfulness Relaxation Delivery

provides CD for home use (1-2 X per day)

subject brings CD to all chemotherapy
sessions, using it before and during
chemotherapy administration
Mindfulness Relaxation Rationale

Relaxation training of patients to be
delivered by nurse:
 to
amplify therapeutic alliance,
 to
pre-emptively condition the chemo.
setting to relaxation, vs. anxiety and
nausea,
 to
embed the intervention in normal
process
Design
Informed Consent
Baseline Assessment
Randomization
Relaxing Music
MR
Chemotherapy
Follow-up
Standard Care
Assessment Schedule
 Baseline
 Middle
 End
3
of course of chemotherapy
of Chemotherapy
months after the end of
chemotherapy
Measures
Item
Measure
N&V
Morrow Assessment of
Nausea
Anxiety
STAI
Mood
POMS
Symptoms of Distress
SCL-90-R
Fatigue
MRI-20
Sleep Quality
PSQI
Quality of Life
FACT-B
Immune function
Cytotoxicity to K562 target
Type-1/Type-2 cytokines
WBC/CBC
Nursing Training Protocol
Preparation

Materials distributed for reading, familiarization
of RN.’s with rationale, purpose, methodology of
study
Nursing Training Protocol
Training Session (1 day)

Group session to review written material,
communicate the essence of the intervention

Review and demonstration of the script

Practice sessions, in pairs or small group

Review with investigator

Refinement and CD production
Nursing Training Protocol
Follow-up

Principal investigator available (E-mail,
telephone) for obstacles, difficulties

‘Refresher’ or ‘trouble-shooting’ sessions:
Tele-conference
Meetings
Progress

111 patients randomized

11 sites trained