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BACKGROUND: Treatment for pancreatic cancer with pharmacological ascorbate (ascorbic acid, vitamin C) decreases tumor progression in preclinical models. A phase I clinical trial was performed to establish safety and tolerability of pharmacological ascorbate combined with gemcitabine in patients with biopsy-proven stage IV pancreatic adenocarcinoma. DESIGN: Nine subjects received twice-weekly intravenous ascorbate (15-125 g) employing Simon's accelerated titration design to achieve a targeted post-infusion plasma level of ≥350 mg/dL (≥20 mM). Subjects received concurrent gemcitabine. Disease burden, weight, performance status, hematologic and metabolic laboratories, time to progression and overall survival were monitored. RESULTS: Mean plasma ascorbate trough levels were significantly higher than baseline (1.46 ± 0.02 vs. 0.78 ± 0.09 mg/dL, i.e., 83 vs. 44 µM, p < 0.001). Adverse events attributable to the drug combination were rare and included diarrhea (n = 4) and dry mouth (n = 6). Dose-limiting criteria were not met for this study. Mean survival of subjects completing at least two cycles (8 weeks) of therapy was 13 ± 2 months. CONCLUSIONS: Data suggest pharmacologic ascorbate administered concurrently with gemcitabine is well tolerated. Initial data from this small sampling suggest some efficacy. Further studies powered to determine efficacy should be conducted.

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This study identified frequency of sexual dysfunction, degree of satisfaction with sexual relationship, differences in sexual function, overall satisfaction and life quality, and desire for and receipt of instruction regarding sexual dysfunction in kidney, pancreas/kidney, and liver transplant recipients. Of the 768 adult recipients surveyed by mailed questionnaire, 39% responded. Intimate relationships were reported by 69.9%; 66.7% indicated satisfaction with their relationship. Twenty-six percent were not sexually active. Transplant groups did not differ significantly regarding satisfaction, sexual function, or quality of life. Satisfaction groups differed significantly regarding intimacy and expected future life and health quality. Frequency of intercourse, desire, orgasm, erection dysfunctions, and the acceptance of partners' advances related to relationship satisfaction. Sixty-seven percent received no instruction concerning sexuality or fertility. Education efforts could validate and support sexual identity among this patient population.

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OBJECTIVE: To determine the impact of pancreas transplantation on the quality of life of renal transplant recipients with diabetes. RESEARCH DESIGN AND METHODS: In this quasi-experimental comparative study of 41 successful pancreas transplant (SP) recipients, 13 failed pancreas transplant (FP) recipients, and 28 kidney alone (KA) transplant recipients, we collected data from individuals who had their pancreas/kidney or kidney alone transplants > or = 6 months before at a university tertiary care center. This study was an extension of a 1992 study of SP and FP recipients. The subject group was enlarged with additional pancreas/kidney recipients and a control group of KA recipients. Five dimensions of life quality were measured. RESULTS: Groups did not differ significantly regarding age, gender, marital status, comorbidity, type of prior dialysis, current kidney function, length of time since transplant, physical activity, symptom burden, emotional state, and feelings of well-being. A significant time by group interaction occurred for quality of life (P = 0.0023) and health (P = 0.0001). Patients in the SP and KA groups perceived their past life and health quality to be significantly lower and their present and future life and health quality to be significantly better than did the FP group. The groups' major concerns differed significantly. The FP group's concern related to diabetes, the SP group's to immunosuppression, and the KA group's to graft rejection. CONCLUSION: Patients with failed pancreas but successful kidney transplants see less improvement in their quality of life than do patients who meet their transplant goals, irrespective of whether they receive a pancreas.

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OBJECTIVE: To comprehensively assess and compare pancreas/kidney transplant recipients' quality of life. RESEARCH DESIGN AND METHODS: This quasi-experimental comparative study of 31 successful and 13 failed pancreas transplant recipients collected data from persons who had received pancreas and kidney transplants > or = 6 mo prior at a university tertiary care center. Physical and social function, symptoms, mental state, and sense of well-being of the recipients were assessed. RESULTS: Groups did not differ significantly regarding age, gender, marital status, onset or length of diabetes, comorbidity, type of prior dialysis, current kidney function, length of time since transplant, physical activity, symptom burden, emotional state, feelings of well-being, and present quality of life and health. A significant time by group interaction occurred for quality of life (P = 0.0013) and health (P = 0.0001). The successful group indicated that both quality of life and health were significantly better than in the past, and continued improvement was expected. The unsuccessful group did not have this perception. Members of the failed group were significantly more satisfied with their social support. The unsuccessful group's major concerns related to diabetes, not immunosuppression. CONCLUSIONS: Recipients of successful pancreas transplants perceived their improvement in health and quality of life to be significantly greater than the unsuccessful recipients.

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Two sequential studies of life quality among pancreas transplant recipients are reported. The first study (n = 32) investigated symptoms of neuropathy, enteropathy and retinopathy, along with well-being post successful transplantation. Patients noted improvement in secondary complications, were satisfied with the procedure and expressed hope for the future. The second study compared physical and social function, burden of symptoms, emotional/mental state and sense of well-being in successful (n = 31) and successful (n = 13) pancreas transplant recipients. Patient satisfaction with pancreas transplantation was high. Successful transplant patients perceived their health to be good, believed it would continue to be good, with life quality becoming better over time. The failed group expected life quality to become worse.

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