Phase I

Study Title: Qigong Mind-Body Exercise for Persistent Post-Surgical Pain in Breast Cancer Survivors: A Pilot Study

Study Type: Phase I/interventional/single-group assignment

Study Sponsor and Collaborators: Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Spaulding Rehabilitation Hospital

Purpose: To evaluate whether participating in a 12-week Qigong program (pronounced chee kung), an exercise program that involves gentle movements combined with breathing/relaxation techniques, also known as mind-body exercise, leads to improvement of pain, physical function, and quality of life among breast cancer survivors who have significant pain after surgery

Primary Outcome Measures: (1) Rate of completion of Qigong mind-body exercise intervention [time frame: 12 months] and (2) number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [time frame: 6 months]

Principal Investigator: Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute; (617) 632-5961, jligibel@partners.org

ClinicalTrials.gov Identifier: NCT02848989

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Study Title: A Phase I Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain

Study Type: Phase I/interventional/single-group assignment

Study Sponsor and Collaborators: University of Texas Southwestern Medical Center

Purpose: To evaluate the effects a single dose of substance P-saporin has on terminally ill cancer patients with intractable chronic pain in the pelvis, lower abdomen, back, or spine

Primary Outcome Measures: Response evaluation criteria [time frame: 8 weeks]

Principal Investigator: Arthur Frankel, MD, UT Southwestern Medical Center; (214) 648-4180, arthur.frankel@utsouthwestern.edu

ClinicalTrials.gov Identifier: NCT02036281

Phase II

Study Title: Phase II Open, Nonrandomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center, University of North Carolina, NewYork-Presbyterian Hospital Cornell Medical Center

Purpose: To discover whether radium-223 is effective in reducing cancer pain in patients with prostate cancer within 12 weeks of treatment. To see whether radium-223 is effective, the patient’s level of pain will be followed throughout the study.

Primary Outcome Measures: Pain response [time frame: 8 weeks]

Principal Investigator: Michael Morris, MD, Memorial Sloan Kettering Cancer Center; (646) 422-4469

ClinicalTrials.gov Identifier: NCT02278055

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Study Title: A Study to Identify Predictors of Response to Duloxetine in Breast Cancer Patients With Chronic Pain

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: American Cancer Society, University of Michigan Cancer Center

Purpose: In this mechanistic study of duloxetine vs placebo, researchers will investigate the change in pain sensitivity with treatment to evaluate both why duloxetine is effective for management of pain for some patients with breast cancer as well as predictors likely candidates to benefit from duloxetine.

Primary Outcome Measures: Change in patient-reported pain between baseline and 5 weeks of treatment with duloxetine [time frame: 5 weeks]

Principal Investigator: Norah L. Henry, MD, PhD, University of Michigan Cancer Center; (800) 865-1125

ClinicalTrials.gov Identifier: NCT01912612

Phase III

Study Title: UW14030: Epidural Anesthesia as Part of an Enhanced Recovery Pathway in Gynecologic Surgery

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: University of Wisconsin (Madison), National Cancer Institute

Purpose: This randomized clinical trial will aim to study epidural anesthesia within an enhanced recovery pathway in reducing pain in patients undergoing gynecologic surgery. To administer epidural analgesia, a small tube is placed in the lower back; the nerves are numbed and the feeling of pain is stopped, which may be helpful for pain control in patients with gynecologic cancer after surgery.

Primary Outcome Measures: Relative pain scores, as measured by the Pain Numeric Rating Scale [time frame: up to 24 hours postsurgery]

Principal Investigator: Lisa Barroilhet, MD, University of Wisconsin, Madison; contact Cancer Connect, (800) 622-8922, cancerconnect@
uwcarbone.edu

ClinicalTrials.gov Identifier: NCT02423876

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Study Title: Reduction of Postmastectomy Pain With the Jacki Recovery Jacket: Randomized Trial

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: Dana-Farber Cancer Institute, Daisy Foundation

Purpose: To study a garment called the Jacki Recovery Jacket, which can be worn after mastectomy, as a possible way to manage pain from surgical drains

Primary Outcome Measures: Pain intensity (on the 0–10 Pain Intensity Numeric Scale) [time frame: 1–2 weeks]

Principal Investigator: Donna Berry, PhD, RN, Dana-Farber Cancer Institute; (617) 632-1909, donna_berry@dfci.harvard.edu

ClinicalTrials.gov Identifier: NCT02976103 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.