Clinical Research Directory

Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy. Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).

Lifestyles and Breast Cancer

Background: In Spain, 1 out of every 11 women will have a breast cancer before the age of 85 years and breast cancer is the leading cause of potential years of life lost. The randomized intervention in PREDIMED trail, using Mediterranean diet with free provision of extra virgin olive oil (MedDiet+EVOO) dramatically and significantly reduced the occurrence of cases of postmenopausal breast cancer. Objectives: Assess the efficacy of a nutritional intervention with MedDiet+EVOO for the prevention of relapses among women with early breast cancer. Methods: Randomized, multicenter trial (LifeBreast) among 766 women diagnosed with early breast cancer. Participants will be randomized in a 1:1 ratio to i) MedDiet+EVOO or ii) low-fat diet. Changes in circulating tumor cells, inflammatory biomarkers, oxidative stress and quality of life will be evaluated. The intervention will be delivered by face-to-face interviews with study dietitian, phone calls, and online tools. Participants in the MedDiet+EVOO group will receive 0.5l/week of EVOO and participants in the low-fat group will receive allotments of different foods, both at no cost. Generalized estimating equations will be used to estimate between-group differences in the following outcomes: circulating tumor cells, inflammatory biomarkers, oxidative stress, and quality of life will be evaluated.

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

This is an open-label Phase 1/2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI). During the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence. Following the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s). During the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell inoculation, and peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.