ACUPUNCTURE FOR CHEMOTHERAPY-INDUCED NEUTROPENIA
This study is one component of the recent NESA Acupuncture Research Collaborative. A central aim of the project is to evaluate the use of acupuncture as an adjunct therapy for the amelioration of chemotherapy-induced neutropenia in women with ovarian and other gynecological cancers. Ovarian cancer is diagnosed in approximately 27,500 women per year in the United States and is the most lethal gynecologic cancer. Most patients with ovarian cancer, regardless of their stage, will receive platinum- and taxane-based chemotherapy, which results in decreased total white blood cell (WBC) and neutrophil counts during chemotherapy. Low neutrophil (neutropenia) counts during the nadir or lowest counts can lead to life-threatening infectious complications. Although there are exogenously administered growth factors, such as granulocyte colony stimulating factor (G-CSF), that can improve WBC counts during chemotherapy, they are expensive and can have side effects. The development of non-toxic means of increasing the nadir white cell counts would be a significant advance for cancer therapy. Traditional Chinese medicine (TCM) has employed acupuncture in an attempt to reduce chemotherapy-induced neutropenia. A review of the Chinese medical literature suggests that acupuncture stimulates production of endogenous G-CSF.
In this randomized controlled trial, we evaluate the use of acupuncture by traditional Chinese clinicians and its effect on the neutrophil and WBC counts during chemotherapy for newly and chronically diagnosed patients with gynecological cancers. Fifty patients will be receiving the similar chemotherapy protocols using carboplatin and paclitaxel, and patients are being randomized to receive either active or sham acupuncture. This will continue during the first cycle of chemotherapy or acupuncture which begins at the 1st nadir day (the 15th day after chemotherapy treatment begins). Endpoint measurements take place at baseline day 15 and at day 43 (the end of week 6 when acupuncture ends). G-CSF measurements are also taken at day 22 and 36. WBC measurements will be taken on days 15, 22, 29, 36, and 43. We are also characterizing acupuncture's effect on the quality of life (QOL) of patients using validated instruments.
Current Status:
Study activities and primary data analysis have been completed; manuscript preparation continues.
Publications/Lectures:
- Lu WD. A systematic review of acupuncture trials for chemotherapy-induced leukopenia. Soc. Integrative Oncology Conference. Seminar presented Nov. 2004, New York,NY.
- Lu WD. Acupuncture for side effects of chemoradiation therapy in cancer patients. Seminars in Oncology Nursing 2005; 21:190-5.
- Lu WD., Hu D, Dean-Clower E, Doherty-Gilman A, Lee H, Matulonis U, Rosenthal D, and Legedza A. Acupuncture for chemotherapy-induced leukopenia: An exploratory meta-analysis of randomized controlled trials. Journal of the Society for Integrative Oncology 2007; 5:1-10.
- Lu WD, Matulonis U, Doherty-Gilman A, Lee H, Dean-Clower E, Rosulek A, Gibson C, Goodman A, Davis RB, Buring JE, Wayne PM, Rosenthal DS, and Penson RT. Acupuncture for chemotherapy-induced neutropenia in patients with gynecologic malignancies: A pilot, randomized, sham-controlled clinical trial. Submitted to Journal of Clinical Oncology.
Principal Investigators:
Weidong Lu, MB, MPH; LicAc (NESA); Ursula Matulonis, MD (Dana Farber Cancer Institute)
NESA Participants:
Acupuncture Providers - Weidong Lu, MB, MPH, LicAc; Zhi Ping Li, MB, LicAc; Yue (Joy) Zhang, LicAc; Qunhao Zhang, LicAc; Guan (Grant) Hou, LicAc; AK Goodman, MD.
Co-Investigators:
Richard Penson, MD (2); David Rosenthal, MD (1)
Other Investigators:
Elizabeth Dean-Clower, MD (1); Anne Doherty, MPH (1); James Griffin, MD (1); Alice Kornblith, PhD (1); Hang Lee, PhD (1)
Collaborating Institutions:
(1) Dana-Farber Cancer Institute, (2) Massachusetts General Hospital
Funding Agency - NCCAM---Grant # 5 U19AT 002022-03
JAPANESE-STYLE ACUPUNCTURE FOR ADOLESCENT ENDOMETRIOSIS-RELATED PAIN
Chronic pelvic pain in adolescent girls accounts for approximately 10% of outpatient gynecology visits. Up to 70% of these patients whose pain is unresponsive to first-line therapy have endometriosis. Surgical treatment with laparoscopy frequently fails to resolve adolescent endometriosis-related pelvic pain. Medical treatments with Gonadotrophin-releasing hormones (GnRH) analogues are not approved for use in adolescents under the age of 16 and elicit menopause-related side effects that some young adults find distressing. Growing evidence suggests that acupuncture may be a safe and effective intervention for a variety of pain syndromes, and that acupuncture is well received by adolescents and their families. To date, however, there have been no randomized controlled trials assessing acupuncture's effectiveness in adolescents suffering from a chronic pain condition.
As part of the NESA Acupuncture Research Collaborative, this pilot randomized controlled trial is assessing the feasibility of conducting a larger, subsequent trial of the efficacy of Japanese acupuncture in adolescent girls suffering from endometriosis-related chronic pelvic pain (CPP). The trial is recruiting and randomizing 42 patients to two arms: active and sham acupuncture. Treatment is offered as an augmentation to the current standard of care which consists of combination hormonal therapy of progestin and estrogen. Japanese acupuncture is an important variant of traditional acupuncture practice that is popular in North America and East Asia but has received little attention from researchers. Clinical reports suggest that the Japanese style, with its less invasive techniques, may be especially suited to this population. Secondary goals of the study are to: 1) assess whether treatment with acupuncture lowers inflammatory cytokine levels associated with the progression of endometriosis; 2) assess whether Oriental medical (OM) diagnostic categories predict patients' acupuncture treatment outcomes; 3) conduct an in-depth qualitative study of adolescent patients' experiences with acupuncture treatment.
Current Status:
Study activities and primary data analysis have been completed; manuscript preparation continues.
Publications:
- Highfield E, Kerr C, Laufer M, Schnyer R, Thomas P, Wayne PM. Adolescent endometriosis-related pelvic pain treated with acupuncture: Two case reports. Journal of Alternative and Complementary Medicine 2006; 12:317-22.
- Schnyer R.N., Iuliano D, Kay J, Shields MH, Wayne PM. Development of treatment protocols in a randomized sham controlled trial evaluating Japanese-style acupuncture for endometriosis-related pelvic pain in adolescents. Submitted to Journal of Alternative and Complementary Medicine.
- Conboy, L.A., Quilty M, Kerr C, Shaw J, Wayne PM. A qualitative analysis of adolescents' experiences of active and sham Japanese-style acupuncture protocols administered in a clinical trial. Journal of Alternative and Complementary Medicine 2008 14 (6):699-705.
- Wayne PM, Kerr C, Schnyer RN, Legedza A, Savetsky German J, Shields MH, Davis RB, Buring JE, Conboy LA, Highfield E, Parton B, Thomas P, Laufer MR. Japanese-style acupuncture for endometriosis-related pelvic pain in adolescents and young women: Results of a randomized sham-controlled trial. Journal of Pediatric and Adolescent Gynecology 2008 Oct: 21(5):247-257.
Principal Investigators:
Catherine Kerr, PhD (2) and Peter Wayne, PhD
Other NESA Participants:
Rosa Schnyer, DiplAc, LicAc (Co-investigator); Lisa Conboy, ScD (Co-investigator); Ellen Highfield, LicAc (Consultant); Diane Iuliano, MAc, LicAc (Consultant); Jacqueline Savetsky German, MPH & NESA 3rd year Student (Research Coordinator); Barbara Parton, RN, LicAc (Research Assistant); Monica Shields, LicAc (Research Assistant); Joe Kay, LicAc (Consultant)
Acupuncture Providers:
Kate Billings, LicAc; Joe Kay, LicAc; Diane Iuliano , LicAc; Susan Panarese, LicAc; Shaune Ralph , LicAc; Bella Rosner, LicAc; Ellen Highfield, LicAc; Sharon Rubrake, LicAc
Other Co-Investigators:
Marc Laufer, MD (1); Anna Legedza ScD (2) (Biostatistician); Phaedra Thomas, RN (1) (Study Coordinator)
Collaborating Institutions:
(1) Children's Hospital Boston, (2) Harvard Medical School's Osher Institute
Funding Agency - NCCAM---Grant # 5 U19AT 002022-03
DEVELOPING A TRADITIONAL EAST ASIAN MEDICINE STRUCTURED INSTRUMENT (TEAMSI)
As part of the NESA Acupuncture Research Collaborative, this study aims to further develop a reliable and valid East Asian medicine (EAM) diagnostic instrument. Appropriate assessment and outcome instrumentation will assist in the development of protocols that more accurately reflect EAM principles, provide a better understanding of the clinical significance and the mechanisms underlying the specificity of acupuncture protocols and techniques, and in doing so develop a research methodology that integrates EAM principles and biomedical science in clinical trials of acupuncture and EAM. The focus of this study is to build on our previous work aimed at operationalizing the OM diagnostic process for use in clinical trials. Our aims are to further develop a previously created EAM diagnostic instrument, evaluate reliability (test-retest and inter-rater reliability) and establish validity (face, content, ecological, incremental validity) of its use. This study aims to take an essential step in facilitating the dialogue between EAM and established research methodology, and in this way contribute to the design and evaluation of clinical trials of acupuncture and EAM.
Phase I of the project focused on development of the TEAMSI-TCM. A consensus-building process using a panel of expert acupuncturists was used to: (a) define the list of questions and criteria that make up the assessment process used by acupuncture practitioners of Traditional Chinese Medicine (TCM), (b) map the best sequence and format to organize them, and (c) incorporate these changes into a revised TEAMSI form.
Phase II of the project, involved testing the reliability and validity of the newly developed TEAMSI-TCM in two arenas: (a) in an experimental setting using intakes from three standardized patients and (b) in a clinical setting using a small sample of 10 patients with dysmenorrhea recruited for this purpose from the greater Boston area. Two manuscripts are currently in preparation. The first considers the reliability of the instrument as measured by agreement between practitioners using the form. The second considers the validity of the form, specifically how truthful to TCM the form is and what the form is like to use. This second analysis uses interview data with practitioners.
Current Status:
Publications:
- Schnyer RN, Conboy LA, Jacobsen E, McKnight P, Goddard T, Moscatelli F, Legedza AT, Kerr C, Kaptchuk TJ, and Wayne PM. Development of a Chinese medicine assessment measure: An interdisciplinary approach to using the Delphi method. Journal of Alternative and Complementary Medicine 2005; 11:1005-13
Principal Investigators:
Rosa Schnyer, DiplAc, LicAc (NESA); Lisa Conboy, ScD (1); and Ted Kaptchuk, LicAc (1)
Other NESA Participants:
Jessica Shaw (current NESA student and research assistant)
Other Participants:
Patrick McKnight (consultant), Catherine Kerr (co-investigator), Eric Jacobson (co-investigator), Mary Quilty (RA)
Collaborating Institutions:
(1) Harvard Medical School's Osher Institute
Funding Agency - NCCAM---Grant # 5 U19AT 002022-03
DIMOCK COMMUNITY HEALTH CENTER CHINESE HERBAL MEDICINE CLINIC CASE REPORTS
The NESA Clinic at the Dimock Community Health Center provides Chinese herbal medicine to an inner city, primarily African-American and Hispanic population. The majority of the herbal clinic patients have chronic conditions with complaints that include diabetes, musculoskeletal conditions and/or pain, gastrointestinal issues, neurological conditions, and gynecological conditions or symptoms.
The objectives of this study are:
- To conduct a limited archival review of the active cases at the NESA Herbal Clinic at the Dimock Community Health Center. This profile will include descriptive data (age, gender, race/ethnicity, initial presentation or main complaint, secondary presentations). This information will comprise a profile of the herbal clinic patients at Dimock: Who are the users of this facility, and for what conditions do they seek treatment?
- Three patients, selected from the active cases described above and who consent to participate in this part of the project, will have their cases described in detail so as to illustrate the Chinese herbal clinic protocol. This will include a brief patient health history, primary and secondary complaints, signs and patterns, Chinese diagnosis, treatment strategy, student intern/clinic supervisor interactions and information on herbal prescriptions including ingredients, dosage, follow-up visits and modified herbal formulas. To insure confidentiality, no identifiable personal characteristics will be included.
Current Status:
Phase 1 has been completed; Phase 2 is in progress.
Principal Investigator:
C.J. Allen, MAc, LicAc, DiplCH
Other NESA Participants:
Peter M. Wayne, Ph.D.; Julie E. Dunn, Ph.D.
Newton, MA 02458