integrative oncology trials
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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 - PowerPoint PPT PresentationTRANSCRIPT
Integrative Oncology Trials
Lorenzo Cohen, PhDDirector, 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 CenterDivision of Cancer Medicine
Community Clinical Oncology Program Research Base
What CIM methods dopatients with cancer use?
Biologically-based Practices
Energy Medicine
Mind-Body Medicine
Manipulative andBody-Based Practices
Whole Medical Systems
CLINIC PATIENTS CAM USERS
# patients %
Breast Clinic 250 129 51.6
GYN Clinic 250 112 44.8
CAM Users Versus Nonusers
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.
12%
17%
19%
30%
42%Doctor never asked
Didn't know they should
Not enough time duringoffice visit
Don't think doctor knowsthe topic
Doctor would have beendismissive or told you
not to do it
Yes 22%
No 77%
DK/NR 1%
Percent of patients who have not discussed CIM
with their doctor
Why patients have not discussed CIM with their
doctor
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
Oncology Nurses and Communicating with Patients about CAM
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.
Study Objectives
Oncology nurses at participating CCOP component sites.
Oncology patients of participating providers (4 per provider).
Participants
Baseline Patient Assessment
Random Assignment to Intervention or Control
Provider and Patient Follow-Up Assessment
Baseline Provider Assessment
Video and Resource List
Baseline Provider Assessment
Video and Resource List
Study Design
Provider and Patient Follow-Up Assessment
2 months
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 post-treatment in one study
Xerostomia
25
27
29
31
33
35
37
baseline 1 2 3 4 5 8
Weeks
XI
Garcia et al., Head & Neck, In Press
Xerostomia Questionnaire
0
10
20
30
40
50
60
70
0 1 2 3 4 5 6 7 8 9 10 11 12
Acupuncture Control
*
*
**
*
*
*
Treatment Week
Lev
el
(p=0.0005)
(p=0.002)
MDASI-H&N
MDASI-Symptoms (13 items)
MDASI-Interference
MDASI-Symptoms (12 items)
0
5
10
15
20
25
30
35
40
0 1 2 3 4 5 6 7 8 9 10 11 12
Acupuncture Control
0
5
10
15
20
25
30
35
40
0 1 2 3 4 5 6 7 8 9 10 11 12
Acupuncture Control
0
5
10
15
20
25
30
0 1 2 3 4 5 6 7 8 9 10 11 12
Acupuncture Control
0
5
10
15
20
25
30
35
0 1 2 3 4 5 6 7 8 9 10 11 12
Acupuncture Control
** *
*
*
†
†
†
*
† (p<0.10)* (p<0.05)
*
†
0
1
2
3
4
5
6
7
8
0 1 2 3 4 5 6 7 8 9 10 11 12
Week
Sal
iva
wei
gh
t
Acpuncture (us)Acupuncture (s)
Control (us)Control (s)
****
**
Saliva production in Acupuncture and Control patients
* (p<0.05)**(p<0.01)
Collected before acu tx
(p=0.005)
(p=0.007)
(p=0.0006)
(p=0.005)
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.
Jon Hunter, Lorenzo Cohen, Laszlo Radvanyi, Jon Hunter, Lorenzo Cohen, Laszlo Radvanyi, Peter MuellerPeter Mueller
MDACC CCC-01-06
Chemotherapy and Mindfulness Chemotherapy and Mindfulness Relaxation: a Randomized TrialRelaxation: a Randomized Trial
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 BarriersTherapeutic 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” InterventionAttributes 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
-Mindfulness Relaxation--Mindfulness Relaxation-
Self-hypnosis
Guided imagery
Yoga breathing
Mindful attitude
Intervention
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 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 Delivery Mindfulness Relaxation Delivery
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
Mindfulness Relaxation RationaleMindfulness Relaxation Rationale
DesignDesignInformed Consent
Baseline Assessment
Randomization
Relaxing Music MR Standard Care
Chemotherapy
Follow-up
Baseline Middle of course of chemotherapy End of Chemotherapy 3 months after the end of
chemotherapy
Assessment ScheduleAssessment Schedule
Measures Item Measure
N&V Morrow Assessment of NauseaAnxiety 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
PreparationPreparation
Materials distributed for reading, familiarization of RN.’s with rationale, purpose, methodology of study
Nursing Training Protocol
Training Session (1 day)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-upFollow-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