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