Brief Report: Stability and Chemical Characteristics of Injectable Ascorbic Acid for Patients With Cancer.

CONTEXT: Intravenous ascorbic acid (IVAA) has been used extensively as part of the management plan for cancer patients in various medical clinics throughout the United States. The current research team has evaluated its effectiveness in patients with cancer as part of an ongoing research program. However, no data are available that support the chemical stability of intravenously injectable ascorbic acid (AA) to ensure its safety and efficacy in that patient population. Its clinical use as well as its use in research conducted in US Food and Drug Administration-approved clinical trials require validation of its stability. OBJECTIVE: The study intended to evaluate the chemical stability of the compounded IVAA that it prepares. DESIGN: The research team conducted a stability analysis within a 6-h period, a period longer than the time required for most infusions, which typically take approximately 2 h. The study evaluated the stability of AA intravenous sets, which are compounded solutions for clinical or hospital use. The IVAA was prepared in sterile water, together with magnesium chloride (MgCl) and calcium gluconate (CaGluc) as buffers. SETTING: The study took place at the Marcus Institute of Integrative Health at Thomas Jefferson University (Philadelphia, PA, USA). OUTCOME MEASURES: The study was performed for 2 dosages of an infusion set: 75 g and 100 g of IVAA. Interval testing included pH, particulate matter by light obscuration, and high-performance liquid chromatography assay. Analyses were performed at baseline and at 2-, 4-, and 6-h test intervals. RESULTS: The results demonstrated that IVAA remained highly stable throughout the 6-h period. It also passed the US Pharmacopeia's criteria for pH and particulates when used with a 0.2 µ filter. CONCLUSIONS: These data suggest that IVAA, when prepared with sterile water, in addition to MgCl and CaGluc, is highly stable and safe to use in patients for up to 6 h after preparation.

Retrospective Evaluation of Clinical Experience With Intravenous Ascorbic Acid in Patients With Cancer.

BACKGROUND: Intravenous ascorbic acid (IV AA) has been used extensively in cancer patients throughout the United States. Currently, there are limited data on the safety and clinical effects of IV AA. The purpose of this study was to expand the current literature using a retrospective analysis of adverse events and symptomatic changes of IV AA in a large sample of cancer patients. METHODS: We conducted a retrospective chart review of all patients receiving IV AA for cancer at the Thomas Jefferson University Hospital over a 7-year period. We assessed all reports of adverse events, laboratory findings, and hospital or emergency department admissions. We also reviewed quality-of-life data, including fatigue, nausea, pain, appetite, and mood. RESULTS: There were 86 patients who received a total of 3034 doses of IV AA ranging from 50 to 150g. In all, 32 patients received only ascorbic acid as part of their cancer management (1197 doses), whereas 54 patients received ascorbic acid in conjunction with chemotherapy (1837 doses). The most common adverse events related to ascorbic acid were temporary nausea and discomfort at the injection site. All events reported in the ascorbic acid alone group were associated with less than 3% of the total number of infusions. Patients, overall, reported improvements in fatigue, pain, and mood while receiving ascorbic acid. CONCLUSIONS: The results of this retrospective analysis support the growing evidence that IV AA is generally safe and well tolerated in patients with cancer, and may be useful in symptom management and improving quality of life.

Costs and Effectiveness of Mindfulness-Based Art Therapy versus Standard Breast Cancer Support Group for Women with Cancer.

BACKGROUND: The results of several studies have demonstrated that women and men with a cancer diagnosis benefit from interventions to reduce distress and improve quality of life (QOL). However, little is known about the costs and effectiveness of such interventions. Identifying a stress-reduction program that is low cost and effective is important for payers, employers, and healthcare professionals, as well as for patients with cancer. OBJECTIVE: To evaluate the direct costs and effectiveness of the mindfulness-based art therapy (MBAT) program compared with the cost and effectiveness of a breast cancer support group (BCSG). METHODS: This economic pilot study evaluated the direct costs and effectiveness of a mindfulness-based intervention for stress reduction in patients with breast cancer who are receiving care versus the cost of a usual care support group used as the comparator. The cost variables for each cohort included the cost of program delivery (ie, staff and supplies), mileage reimbursements, medication costs, and healthcare utilization costs. Effectiveness was measured by a change in quality-adjusted life-year derived from the 36-Item Short-Form Health Survey (SF-36) QOL battery. RESULTS: Overall, the cost for 191 participants in the MBAT intervention group was $992.49 per participant compared with $562.71 per participant for the BCSG intervention. Both interventions achieved a similar change in healthcare utilization based on the SF-36 QOL battery. Although the MBAT intervention was more costly than a BCSG intervention, sensitivity analysis showed that the cost-effectiveness of the MBAT intervention could achieve parity with that of a BCSG if some intervention-related costs, such as staff time and supplies, were reduced. CONCLUSION: As psychosocial cancer care becomes more refined with time, it will be important to determine the best and most cost-effective interventions for patients with cancer, particularly in light of healthcare reform. Information from this study could help inform payers, employers, and other stakeholders regarding which interventions would be least costly and most effective for patients with cancer.

Synergistic effects of ascorbate and sorafenib in hepatocellular carcinoma: New insights into ascorbate cytotoxicity.

We investigated the mechanism of selective ascorbate-induced cytotoxicity in tumor cells, including Hep G2 cells, compared to primary hepatocytes. H2O2 formation was required for ascorbate cytotoxicity, as extracellular catalase treatment protected tumor cells. H2O2 generated by glucose oxidase treatment also caused cell killing, but treatment with a pharmacologic dose (5-20mM) of ascorbate was significantly more cytotoxic at comparable rates of H2O2 production, suggesting that ascorbate enhanced H2O2 cytotoxicity. This was further supported by the finding that ascorbate at a non-cytotoxic dose (1mM) enhanced cell killing caused by glucose oxidase. Consistent with this conclusion, ascorbate treatment caused deregulation of cellular calcium homeostasis, resulting in massive mitochondrial calcium accumulation. Ascorbate acted synergistically with the chemotherapeutic sorafenib in killing Hep G2 cells, but not primary hepatocytes, suggesting adjuvant ascorbate treatment can broaden sorafenib's therapeutic range. Sorafenib caused mitochondrial depolarization and prevented mitochondrial calcium sequestration. Subsequent ascorbate addition further deregulated cellular calcium homeostasis promoting cell death. Additionally, we present the case of a patient with hepatocellular carcinoma (HCC) who had prolonged regression of a rib metastasis upon combination treatment with ascorbate and sorafenib, indicating that these studies have direct clinical relevance.

Current evidence regarding the management of mood and anxiety disorders using complementary and alternative medicine.

This article is an updated review on the potential uses of complementary and alternative medicine (CAM) approaches for the management of patients with mood and anxiety disorders. We have focused this current paper on the different types of disorders and the CAM intervention which might be useful. This is in distinction to the prior paper which focused on the CAM interventions. In addition, we have provided a discussion of more recent studies that help to further inform practitioners about CAM interventions in these disorders. Mood and anxiety disorders are among the most prevalent mental health issues affecting people today and there are many approaches towards their management. CAM interventions can include supplements, botanical remedies, meditation and spiritual practices, acupuncture, and dietary practices. There are a growing number of research studies on the effectiveness of CAM interventions in mood and anxiety disorders, and this review evaluates and critiques such data.

Meditation and neurodegenerative diseases.

Neurodegenerative diseases pose a significant problem for the healthcare system, doctors, and patients. With an aging population, more and more individuals are developing neurodegenerative diseases and there are few treatment options at the present time. Meditation techniques present an interesting potential adjuvant treatment for patients with neurodegenerative diseases and have the advantage of being inexpensive, and easy to teach and perform. There is increasing research evidence to support the application of meditation techniques to help improve cognition and memory in patients with neurodegenerative diseases. This review discusses the current data on meditation, memory, and attention, and the potential applications of meditation techniques in patients with neurodegenerative diseases.

Diet and nutrition in cancer survivorship and palliative care.

The primary goal of palliative cancer care is typically to relieve suffering and improve quality of life. Most approaches to diet in this setting have focused only on eating as many calories as possible to avoid cachexia. However, as the concept of palliative care has evolved to include all aspects of cancer survivorship and not just end of life care, there is an increasing need to thoughtfully consider diet and nutrition approaches that can impact not only quality of life but overall health outcomes and perhaps even positively affect cancer recurrence and progression. In this regard, there has been a recent emphasis in the literature on nutrition and cancer as an important factor in both quality of life and in the pathophysiology of cancer. Hence, the primary purpose of this paper is to review the current data on diet and nutrition as it pertains to a wide range of cancer patients in the palliative care setting.

Psychosocial benefits of a novel mindfulness intervention versus standard support in distressed women with breast cancer.

OBJECTIVE: It is well documented that stress is associated with negative health outcomes in cancer patients. The purpose of this study was to assess the effects of a novel mindfulness intervention called mindfulness-based art therapy (MBAT) versus standard educational support, on indices of stress and quality of life in breast cancer patients with high stress levels. METHODS: A total of 191 women were enrolled, stratified by age and stress level, and randomized to receive either an 8-week MBAT intervention or a breast cancer educational support program of equal time and duration. Psychosocial stress was measured using the Symptoms Checklist-90-Revised, and quality of life was measured using the Medical Outcomes Study Short-Form Health Survey at baseline, immediately post-intervention, and at 6 months. RESULTS: Results showed overall significant improvements in psychosocial stress and quality of life in both the MBAT and educational support groups immediately post-intervention; however, participants with high stress levels at baseline had significantly improved overall outcomes only in the MBAT group, both immediately post-intervention and at 6 months. In addition, at 6 months follow-up, participants attending five or more sessions trended toward retaining treatment effects better in the MBAT than in the control group. Finally, black women and white women were similar in terms of how they benefited from the MBAT intervention, even though white participants tended to have higher educational level and marital status. CONCLUSIONS: In conclusion, MBAT is associated with significant, sustained benefits across a diverse range of breast cancer patients, particularly those with high stress levels.

Patients seek integrative medicine for preventive approach to optimize health.

CONTEXT: Despite the tremendous growth of integrative medicine (IM) in clinical settings, IM has not been well characterized in the medical literature. OBJECTIVE: To describe characteristics and motivation of patients seeking care at an IM clinic. DESIGN, SETTING, AND PARTICIPANTS: Patients from a nine-site practice-based research network participated in this cross-sectional survey. Clinicians documented patients' medical conditions. MAIN OUTCOME MEASURES: Patients provided information on demographics, lifestyle factors, and reasons for seeking care at an IM center. Clinicians documented the medical condition treated and procedures performed at the visit. RESULTS: A total of 4,182 patients (84.5% white; 72.7% college-educated; and 73.4% female) reported their most important reasons for seeking IM. Top-ranked reasons were (1) "to improve health and wellness now to prevent future problems" (83.9%); (2) "to try new options for health care" (76.7%); and (3) "to maximize my health regardless of whether or not my illness is curable" (74.6%). Interestingly, the same top reasons were reported by subgroups of patients who sought IM for wellness, acute care, or chronic illness. Patient reports of lifestyle also demonstrated healthier behaviors than national samples indicate. Patients seeking clinical care at IM centers desire an expanded paradigm of health care, one that seeks to maximize health.

Changes in cerebral blood flow and anxiety associated with an 8-week mindfulness programme in women with breast cancer.

This study employed functional magnetic resonance imaging to evaluate changes in cerebral blood flow (CBF) associated with the Mindfulness-based Art Therapy (MBAT) programme and correlate such changes to stress and anxiety in women with breast cancer. Eighteen breast cancer patients were randomized to the MBAT or education control group. The patients received the diagnosis of breast cancer between 6 months and 3 years prior to enrollment and were not in active treatment. The age of participants ranged from 52 to 77 years. A voxel-based analysis was performed to assess differences at rest, during meditation and during a stress task. The anxiety sub-scale of the Symptoms Checklist-90-Revised was compared with changes in resting CBF before and after the programmes. Subjects in the MBAT arm demonstrated significant increases in CBF at rest and during meditation in multiple limbic regions, including the left insula, right amygdala, right hippocampus and bilateral caudate. Patients in the MBAT programme also had a significant correlation between increased CBF in the left caudate and decreased anxiety scores. In the MBAT group, responses to a stressful cue resulted in reduced activation of the posterior cingulate. The results demonstrate that the MBAT programme was associated with significant changes in CBF, which correlated with decreased anxiety over an 8-week period.

Complementary and alternative medicine therapies in mood disorders.

This article reviews the potential uses of complementary and alternative medicine (CAM) techniques for individuals with mood disorders. Mood disorders are among the most prevalent mental health issues today and there are many approaches towards their management. While many different types of medication are available, more and more people turn to CAM interventions to help manage their mood disorders. CAM interventions can include herbal remedies, acupuncture and meditation. There is an increasing number of research studies on CAM intervention in mood disorders, and this article critiques such data and attempts to provide a clinical perspective within which these CAM interventions might be considered.

Potential role of mind-body therapies in cancer survivorship.

The use of complementary and alternative medicine (CAM) by cancer survivors is high, particularly among those with psychosocial distress, poor quality of life, culturally based health beliefs, and those who experience health disparities in the mainstream healthcare system. As the number of cancer survivors continues to increase, so does the diversity of the survivorship population, making it increasingly important to understand and address the CAM culture in different survivor groups. Given the known communication barriers between cancer patients and their physicians regarding CAM, it would be useful for oncology providers to have a platform from which to discuss CAM-related issues. It is proposed that mind-body therapies with some basis in evidence could provide such a platform and also serve as a possible means of connecting cancer survivors to psychosocial supportive services. This article reviews a few mind-body therapies that may have particular relevance to cancer survivors, such as hypnosis and meditation practices. A theoretical foundation by which such therapies provide benefit is presented, with particular emphasis on self-regulation.

Managing cancer pain with nonpharmacologic and complementary therapies.

Nonpharmacologic interventions are important adjuncts to treatment modalities for patients with cancer pain. A variety can be used to reduce pain and concomitant mood disturbance and increase quality of life. Physicians may feel relatively uninformed about which modalities have been used for patients with cancer and have scientific support. This article reviews several nonpharmacologic and complementary and alternative modalities commonly used by patients with cancer pain. It focuses on those having empirical support or promising preliminary evidence, with the goal of familiarizing physicians with therapies that may complement regular oncologic care. This review updates an article published in November 2005. An anecdotal case study has been added to illustrate incorporation of nonpharmacologic and complementary therapies in the treatment of a patient with cancer-related pain.

A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer.

The purpose of this study was to gather data on the efficacy of a newly developed psychosocial group intervention for cancer patients, called mindfulness-based art therapy (MBAT). One hundred and eleven women with a variety of cancer diagnoses were paired by age and randomized to either an eight-week MBAT intervention group or a wait-list control group. Ninety-three participants (84%) completed both the pre- and post-study measurements. As compared to the control group, the MBAT group demonstrated a significant decrease in symptoms of distress (as measured by the Symptoms Checklist-90-Revised) and significant improvements in key aspects of health-related quality of life (as measured by the Medical Outcomes Study Short-Form Health Survey). This investigation of MBAT provides initial encouraging data that support a possible future role for the intervention as a psychosocial treatment option for cancer patients.

Nonpharmacologic and complementary approaches to cancer pain management.

Nonpharmacologic interventions are important adjuncts to treatment modalities for patients with cancer pain. A variety of modalities can be used to reduce pain and concomitant mood disturbance and increase quality of life. Physicians may feel relatively uninformed about which modalities have been used for patients with cancer and which have scientific support. This article reviews a few of the nonpharmacologic and complementary and alternative modalities commonly used by patients with cancer pain. It focuses on those modalities that have empirical support or promising preliminary evidence, with the goal of familiarizing physicians with treatment modalities that may complement regular oncologic care.

Complementary medicine in chronic cancer care.

Although advancements in cancer care have led to increased cure rates and survival times, those coping with the long-term sequelae of a cancer diagnosis often report high levels of distress, poor health-related quality of life, and unmet psychosocial needs. The shortcomings of the conventional biomedical system at sufficiently addressing these chronic illness issues are a primary reason that many patients turn to complementary and alternative medicine (CAM). Although patients usually use such treatments in addition to conventional care, they often do not discuss doing so with their conventional physicians, who are perceived as being unreceptive to the topic. Physicians may feel uninformed about CAM treatments, especially given the relatively small amount of data on the topic available in the medical literature. This article reviews a few CAM modalities commonly used by cancer survivors and those with chronic cancer illness, with a particular focus on familiarizing physicians with treatments that may potentially complement regular oncologic care by decreasing stress and enhancing health-related quality of life.