Integrative Oncology Trials

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Integrative Oncology Trials
Lorenzo Cohen, PhD Director, Integrative Medicine
Program
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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
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What CIM methods do patients with cancer use?
Biologically-based Practices
Mind-Body Medicine
Manipulative and Body-Based Practices
Whole Medical Systems
Energy Medicine
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CAM Users Versus Nonusers
Navo et al., 2004
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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.

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Why patients have not discussed CIM with their
doctor
Percent of patients who have not discussed CIM
with their doctor
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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
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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.

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Participants

• Oncology nurses at participating CCOP component
  sites.
• Oncology patients of participating providers (4
  per provider).

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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
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Progress

• 185 patients
• 8 sites registered

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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

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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

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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

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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

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Xerostomia
XI
Weeks
Garcia et al., Head Neck, In Press
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Xerostomia Questionnaire
(p0.0005)
(p0.002)
Level
Treatment Week
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MDASI-Symptoms (12 items)
MDASI-Symptoms (13 items)




MDASI-HN
MDASI-Interference
(p

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Saliva production in Acupuncture and Control
patients
(p0.0006)


(p0.005)


Collected before acu tx
(p0.007)
(p0.005)
(p 22
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.

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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. 
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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.

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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.

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Chemotherapy and Mindfulness Relaxation a
Randomized Trial

• Jon Hunter, Lorenzo Cohen, Laszlo Radvanyi, Peter
  Mueller
• MDACC CCC-01-06

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Side Effects

• Cytotoxic
• Nausea and vomiting
• Alopecia
• Immunosuppression
• Anorexia
• Stomatitis
• Diarrhea

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Side Effects

• Conditioned
• Nausea, Vomiting
• Anxiety
• Immunosuppression
• Fatigue (?)

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Interventions - General

• Cognitive/behavioral therapy
• relaxation
• guided imagery
• biofeedback
• progressive muscle relaxation
• hypnosis
• group and individual intervention

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Interventions Nausea and Vomiting

• guided imagery
• systematic desensitization
• hypnosis
• progressive muscle relaxation

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Outcomes

• Treatment and disease related symptoms
• Emotional adjustment
• Functional adjustment
• Immune function
• Medical outcomes (chemotherapy dose)
• Survival?

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Therapeutic Barriers

• Not easily applicable to varied settings or
  illnesses
• Typically administered by a trained mental health
  professional
• Labor intensive and costly

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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

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Intervention

• -Mindfulness Relaxation-
• Self-hypnosis
• Guided imagery
• Yoga breathing
• Mindful attitude

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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 .

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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

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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

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Design

• Informed Consent
• Baseline Assessment
• Randomization
• Relaxing Music MR
  Standard Care
• Chemotherapy
• Follow-up

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Assessment Schedule

• Baseline
• Middle of course of chemotherapy
• End of Chemotherapy
• 3 months after the end of chemotherapy

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Measures

• Item
  Measure
• NV
  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

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Nursing Training Protocol

• Preparation
• Materials distributed for reading,
  familiarization of RN.s with rationale, purpose,
  methodology of study

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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

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Nursing Training Protocol

• Follow-up
• Principal investigator available (E-mail,
  telephone) for obstacles, difficulties
• Refresher or trouble-shooting sessions
• Tele-conference
• Meetings

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Progress

• 111 patients randomized
• 11 sites trained

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