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 Energy Medicine Mind-Body Medicine Manipulative and Body-Based Practices Whole Medical Systems

CLINICPATIENTSCAM USERS # patients% Breast Clinic GYN Clinic 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.

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 Weeks XI Garcia et al., Head & Neck, In Press

Xerostomia Questionnaire * * * * * * * Treatment Week Level (p=0.0005) (p=0.002)

MDASI-H&N MDASI-Symptoms (13 items) MDASI-Interference MDASI-Symptoms (12 items) * * * * * † † † * † (p<0.10) * (p<0.05) * †

* ** * 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, Peter Mueller MDACC CCC Chemotherapy and Mindfulness Relaxation: 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 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

-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

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

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 Rationale

Design Informed 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 Schedule

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 LifeFACT-B Immune functionCytotoxicity 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 ( , telephone) for obstacles, difficulties ‘Refresher’ or ‘trouble-shooting’ sessions: Tele-conference Meetings

Progress 111 patients randomized 11 sites trained