A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN).

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. METHODS: The primary end point was "average pain" after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. RESULTS: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the "real" ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the "real" group (P = .14). All "real" patients wanted to continue treatment if available. DISCUSSION: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

Through our eyes: exploring African-American men's perspective on factors affecting transition to manhood.

BACKGROUND: Premature mortality and disparities in morbidity observed in African-American men may be associated with factors in their social, economic, and built environments that may be especially influential during the transition to adulthood. OBJECTIVE: To have young, African-American men from Los Angeles County identify and prioritize factors associated with their transition to manhood using photovoice methodology and pile-sorting exercises. DESIGN: Qualitative study using community-based participatory research (CBPR) and photovoice PARTICIPANTS: Twelve African-American men, ages 16-26 years, from Los Angeles County, California. APPROACH: We used CBPR principles to form a community advisory board (CAB) whose members defined goals for the partnered project, developed the protocols, and participated in data collection and analysis. Participants were given digital cameras to take 50-300 photographs over three months. Pile-sorting techniques were used to facilitate participants' identification and discussion of the themes in their photos and selected photos of the group. Pile-sorts of group photographs were analyzed using multidimensional scaling and hierarchical cluster analysis to systematically compare participants' themes and identify patterns of associations between sorted photographs. Sub-themes and related quotes were also elicited from the pile-sorting transcripts. The CAB and several study participants met periodically to develop dissemination strategies and design interventions informed by study findings. KEY RESULTS: Four dominant themes emerged during analysis: 1) Struggles face during the transition to manhood, 2) Sources of social support, 3) Role of sports, and 4) Views on Los Angeles lifestyle. The project led to the formation of a young men's group and community events featuring participants. CONCLUSIONS: CBPR and photovoice are effective methods to engage young, African-American men to identify and discuss factors affecting their transition to manhood, contextualize research findings, and participate in intervention development.

Heterogeneity of breast cancer and implications of adjuvant chemotherapy.

Historically, in selecting adjuvant chemotherapy for patients with breast cancer, anatomy, including tumor size and nodal status, has played the primary role. As a result of analyses of genomic and clinical data, breast cancers are now thought to be a family of diseases. Major subtypes of breast cancer include HER-2 positive disease, basal-like or triple negative tumors, and at least two types of hormonally sensitive cancers. Using the nomenclature developed in the gene expression array studies, these two types are often referred to as luminal A and luminal B. Estrogen receptor negative tumors relapse earlier than estrogen receptor positive tumors. In general, estrogen receptor negative cancers are also more responsive to chemotherapy. In contrast, estrogen positive tumors appear to be somewhat less responsive to chemotherapy, but endocrine therapy can be of substantial benefit in decreasing the risk of disease recurrence. Women with HER-2 positive disease derive significant benefit with the use of trastuzumab. The role of chemotherapy in preventing disease recurrence in patients with estrogen receptor positive tumors is being reevaluated. Recent data suggests that chemotherapy has the greatest benefit in those patients with estrogen receptor positive cancers whose tumors are HER-2 positive disease, weakly ER positive, and/or have high nuclear grade. In the future, breast cancer treatment will be more targeted to the tumor and tailored to the individual with the use of genomic and clinical data.