Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial.

Background: Malnutrition is a common and distressing condition among pancreatic cancer patients. Fewer than a quarter of pancreatic cancer patients receive medical nutrition therapy (MNT), important for improving nutritional status, weight maintenance, quality of life and survival. System, provider, and patient level barriers limit access to MNT. We propose to examine the feasibility of a 12-week multi-level, digital health intervention designed to expand MNT access among pancreatic cancer patients. Methods: Individuals with advanced pancreatic cancer starting chemotherapy (N = 80) will be 1:1 randomized to the intervention or usual care. The Support Through Remote Observation and Nutrition Guidance (STRONG) intervention includes system-level (e.g., routine malnutrition and screening), provider-level (e.g., dietitian training and web-based dashboard), and patient-level strategies (e.g., individualized nutrition plan, self-monitoring of dietary intake via Fitbit, ongoing goal monitoring and feedback). Individuals receiving usual care will be referred to dietitians based on their oncologists' discretion. Study assessments will be completed at baseline, 4-, 8-, 12-, and 16-weeks. Results: Primary outcomes will be feasibility (e.g., recruitment, retention, assessment completion) and acceptability. We will collect additional implementation outcomes, such as intervention adherence, perceived usability, and feedback on intervention quality via an exit interview. We will collect preliminary data on outcomes that may be associated with the intervention including malnutrition, quality of life, treatment outcomes, and survival. Conclusion: This study will advance our knowledge on the feasibility of a digital health intervention to reduce malnutrition among individuals with advanced pancreatic cancer. Trial registration: NCT05675059, registered on December 9, 2022.

Survivors Overcoming and Achieving Resiliency (SOAR): Mindful Eating Practice for Breast Cancer Survivors in a Virtual Teaching Kitchen.

The practice of mindful eating brings awareness to food choices, brings attention to the eating experience, and encourages selecting and preparing food that is both satisfying and nourishing. We examined mindful eating in breast cancer survivors following a 9-week, multidisciplinary virtual teaching kitchen intervention called Survivors Overcoming and Achieving Resiliency (SOAR). SOAR engaged participants through weekly cooking classes that also taught multiple domains of mindfulness. Participants (n = 102) were breast cancer survivors and completed the Mindful Eating Questionnaire (MEQ) prior to and after completion of the intervention. Linear regression analyses examined relationships between the aspects of mindful eating and body mass index (BMI). Wilcoxon (paired) rank sum tests evaluated the significance of the change in the MEQ total sum and subscales scores. A total of 102 participants completed both the pre- and post-intervention surveys. The mean change between the pre- and post-SOAR MEQ summary scores was 0.12 (sd = 0.30; Wilcoxon p-value = 0.0003). All MEQ subscale scores significantly increased with the exception of the distraction subscale. The MEQ summary scores increased for participants across both BMI stratifications. The SOAR teaching kitchen represents one of the first interventions that is tailored for breast cancer survivors and combines behavioral strategies from mindful eating training to nutritional knowledge and culinary medicine pedagogy in a virtual teaching kitchen. Further research is needed to examine whether mindful eating practices among cancer survivors result in sustainable healthy eating behaviors and food choices consistent with the cancer risk reduction guidelines.

Results of a randomized phase I dose-finding trial of several doses of isoflavones in men with localized prostate cancer: administration prior to radical prostatectomy.

The purpose of this phase I dose-finding randomized controlled trial was to evaluate the safe and effective dose of isoflavones to be used in future clinical trials for prostate cancer prevention. Forty-five eligible men were supplemented with 40, 60, and 80 mg of purified isoflavones or no supplement from biopsy to prostatectomy. Compliance with the study agent, toxicity, and changes in plasma isoflavones, serum steroid hormones, prostate-specific antigen (PSA), and tissue Ki-67 were analyzed from baseline to completion of the study. Forty-four subjects completed the study with a duration of intervention of 30 (+/- 3) days. We observed significant increases in plasma isoflavones with treatment for all doses compared with controls without producing any toxicity. Significant increases in serum total estradiol were observed in the 40 and 60 mg isoflavone-treated arms. However, a significant increase in serum free testosterone was observed in the 60 mg isoflavone-treated arm. Changes in serum sex hormone-binding globulin, PSA, and percentage of tissue Ki-67 were not statistically significant with treatment for this sample size and duration of intervention. Our results identify a safe dose of purified isoflavones for future clinical trials and establish the need for further definitive, well-powered trials to examine the role of isoflavones in prostate carcinogenesis.

Results of a Randomized Clinical Trial of the Action of Several Doses of Lycopene in Localized Prostate Cancer: Administration Prior to Radical Prostatectomy.

PURPOSE: The purpose of this Phase II randomized-controlled trial was to evaluate the safety and effect of administering several doses of lycopene to men with clinically localized prostate cancer, on intermediate endpoint biomarkers implicated in prostate carcinogenesis. METHODS: Forty-five eligible men with clinically localized prostate cancer were supplemented with 15, 30 or 45 mg of lycopene or no supplement from biopsy to prostatectomy. Compliance to study agent, toxicity, changes in plasma lycopene, serum steroid hormones, PSA and tissue Ki-67 were analyzed from baseline to completion of intervention. RESULTS: Forty-two of forty-five five subjects completed the intervention for approximately 30 days from the time of biopsy until prostatectomy. Plasma lycopene increased from baseline to post treatment in all treatment groups with greatest increase observed in the 45 mg lycopene-supplemented arm compared to the control arm without producing any toxicity. Overall, subjects with prostate cancer had lower baseline levels of plasma lycopene similar to those observed in previous studies in men with prostate cancer. Serum free testosterone decreased with 30 mg lycopene supplementation and total estradiol increased significantly with 30 mg and 45 mg supplementation from baseline to end of treatment, with no significant increases in serum PSA or tissue Ki-67. These changes were not significant compared to the control arm for this sample size and duration of intervention. CONCLUSIONS: Although antioxidant properties of lycopene have been hypothesized to be primarily responsible for its beneficial effects, our study suggests that other mechanisms mediated by steroid hormones may also be involved.

A Phase II randomized, placebo-controlled clinical trial of purified isoflavones in modulating steroid hormones in men diagnosed with localized prostate cancer.

Our purpose was to evaluate the safety and effectiveness of purified isoflavones in producing an increase in plasma isoflavones and a corresponding change in serum sex hormone binding globulin (SHBG) and steroid hormone levels in men diagnosed with early stage prostate cancer. In this Phase II randomized, double-blinded, placebo-controlled trial, 53 prostate cancer patients with a Gleason score of 6 or below were supplemented with 80 mg purified isoflavones or placebo for 12 weeks. Changes in plasma isoflavones, serum steroid hormones, and safety markers were analyzed from baseline to 12 wk. A total of 50 subjects completed the study. Although significant increases in plasma isoflavones (P < 0.001) was observed with no clinical toxicity, the corresponding modulation of serum SHBG, total estradiol, and testosterone in the isoflavone-treated group compared to men receiving placebo was nonsignificant. Increasing plasma isoflavones failed to produce a corresponding modulation of serum steroid hormone levels in men with localized prostate cancer. The study establishes the need to explore other potential mechanisms by which prolonged and consistent purified isoflavone consumption may modulate prostate cancer risk.

Safety of purified isoflavones in men with clinically localized prostate cancer.

Our purpose was to evaluate the safety of 80 mg of purified isoflavones administered to men with early stage prostate cancer. A total of 53 men with clinically localized prostate cancer, Gleason score of 6 or below, were supplemented with 80 mg purified isoflavones or placebo for 12 wk administered in 2 divided doses of 40 mg to provide a continuous dose of isoflavones. Compliance, changes in plasma isoflavones, and clinical toxicity were analyzed at baseline, 4, and 12 wk. A total of 50 subjects completed the 12-wk intervention. A continuous, divided-dose administration of 80 mg/day of purified isoflavones at amounts that exceeded normal American dietary intakes significantly increased (P < 0.001) plasma isoflavones in the isoflavone-treated group compared to placebo and produced no clinical toxicity. With the current evidence on the cancer preventive properties of isoflavones, these results are significant and offer promise for these phytochemicals to be developed as potent agents to prevent cancer progression.

A case-control study evaluating the association of purposeful physical activity, body fat distribution, and steroid hormones on premenopausal breast cancer risk.

The objective of this case-control study was to investigate the relationship between purposeful physical activity, body fat distribution, body mass index, and steroid hormones. These factors are known to be implicated in modulating breast cancer risk in premenopausal women. A total of 112 newly diagnosed, premenopausal breast cancer patients and 106 age-matched premenopausal disease-free controls were admitted to the study. Information regarding personal, medical, hormonal, and reproductive history, smoking and alcohol use, physical activity history, and anthropometric measurements was obtained. Serum samples for steroid hormone assays were collected and analyzed. Disease-free premenopausal controls had a significantly higher physical activity index (PAI) (p

Isoflavones in breast cancer chemoprevention: where do we go from here?

Based on the evidence from epidemiological, animal, in vitro data and human clinical trials, it is evident that isoflavones are promising agents for breast cancer chemoprevention. It is also evident that the form of isoflavone used (purified vs soy products), dose of isoflavone used (low vs high), timing and duration of exposure of isoflavones appears to play a major role in determining agonistic or antagonistic effects. Collectively, these isoflavones have enough evidence to warrant use in a number of clinical trials to examine its efficacy as a potential chemopreventive agent for breast cancer. In this comprehensive review, we attempt to summarize the evidence demonstrating the potential use of isoflavones in breast cancer chemoprevention and the rationale to examine a combination of biochemical, morphological and molecular intermediate endpoint biomarkers of breast cancer risk to examine the efficacy of this promising agent.

The specific role of isoflavones in reducing prostate cancer risk.

AIMS: To evaluate the effectiveness of supplementing a group of early stage prostate cancer patients, with 60 mg of soy isoflavones in producing a change in hormonal and proliferative risk parameters that are implicated in prostate cancer promotion. METHODS: Seventy six eligible prostate cancer patients with a Gleason score of 6 or below, between ages 50 and 80 were admitted and supplemented with soy isoflavones or placebo for a 12 week period and changes in PSA and steroid hormones were analyzed at baseline and post intervention. RESULTS: Fifty-nine patients completed the 12-week intervention. Serum free testosterone was reduced or showed no change in 61% of subjects in the isoflavone group compared to 33% in the placebo group. Serum total PSA decreased or was unchanged in 69% of the subjects in the isoflavone treated group compared to 55% in the placebo group. However, we did not see an increase in SHBG levels. Nineteen percent of subjects receiving soy isoflavones reduced total PSA by two points or more during the intervention period. CONCLUSIONS: These data suggest that supplementing early stage prostate cancer patients with soy isoflavones, even in a study of short duration, altered surrogate markers of proliferation such as serum PSA and free testosterone in a larger number of subjects in the isoflavone supplemented group than the group receiving placebo. The study establishes the need to explore further the effects of prolonged and consistent soy consumption, which could potentially delay onset of histologic disease in this patient population.

Fatigue, weight gain, lethargy and amenorrhea in breast cancer patients on chemotherapy: is subclinical hypothyroidism the culprit?

BACKGROUND: The purpose of this study was to prospectively observe the relative contribution of each viable mechanism such as hyperphagia, physical activity, body composition, steroid hormonal and thyroid function, fatigue scores on changes in body weight in breast cancer patients, receiving adjuvant chemotherapy. METHODS: This was a prospective observational research design where 198 consecutive breast cancer patients receiving adjuvant chemotherapy were monitored from start to end and 6 months post-therapy on changes in anthropometics, fatigue, nutritional intake, physical activity, thyroid and steroid hormones. RESULTS: We observed a weight gain over >5 lb in 22.2% of this patient population with a significant and progressive gain of 6.7 lb (P < 0.0001) at 6 months. Ninety four percent of all patients reported fatigue and 56% of patients reported lowered physical activity. A significant reduction in serum free and total estradiol (P < 0.0001) was observed indicative of reduction in ovarian function with 86% amenorrehic at the end of treatment. A significant reduction in mean serum triiodothyronine uptake levels (P < 0.05), in addition to a significant increase in TBG (P < 0.0001) from baseline to end of chemotherapy, was observed. In addition 20-25% of this patient group was already diagnosed with clinical hypothyroidism at diagnosis and treated. Changes in fatigue frequency and serum sex-hormone-binding globulin (SHBG) were variables significantly predictive of weight gain (P < 0.0001). CONCLUSIONS: Cytotoxic agents may influence thyroid function in breast cancer patients contributing to and progressively worsening symptoms such as weight gain, amenorrhea, fatigue and lowered physical activity in this population. The present study indicates the value of screening breast cancer patients for thyroid function at diagnosis or pre-treatment.

Use of complementary/integrative nutritional therapies during cancer treatment: implications in clinical practice.

BACKGROUND: The objectives of this study were to determine the prevalence and characterize the use of complementary/integrative nutritional therapies (CINTs) by patients during cancer treatment. METHODS: This retrospective review used data collected as a part of standard clinical care provided by the registered clinical dietitians and included nutritional history, demographic variables, anthropometrics, prevalence of use, and the specific integrative nutritional therapies used by these patients during cancer treatment. RESULTS: Twenty-nine percent of 820 patients reported use of CINTs not prescribed by their physician. Caucasians and patients over age 60 were the principal users of CINTs during treatment. Modular vitamins were the most frequently reported additive (86.9%), followed by botanicals/biologics (43.8%) and mineral supplements (28.6%). CONCLUSIONS: A considerable proportion of cancer patients use unproven CINTs during cancer treatment. The health professional should become more aware of the complementary/integrative therapies that their patients are using during cancer treatment.

The specific role of isoflavones on estrogen metabolism in premenopausal women.

BACKGROUND: There is increasing evidence that dietary factors may play a role in the production, metabolism, and bioavailability of sex hormones and their impact on target tissues. The specific objective of this study was to evaluate the effectiveness of supplementing a group of premenopausal women who were free of breast carcinoma with a dietary supplement of isoflavones (40 mg per day) in producing a change in steroid hormones and menstrual cycle length. METHODS: Sixty-eight consecutively recruited, premenopausal, omnivorous women of all races and ethnicities between the ages of 25 years and 55 years were admitted to the study and randomized to an experimental group supplemented with soy (40 mg genistein per day) or to a control group that consumed a placebo for a 12-week period. Changes in their anthropometric, nutritional, and hormonal biomarkers from early follicular phase were analyzed at baseline and post-intervention. RESULTS: Serum-free estradiol and estrone levels decreased moderately in the experimental group. Serum hormone-binding globulin levels increased in 41.4% of women in the experimental group compared with 37.5% of women in the placebo group. Free estradiol decreased in 53.85% of women in the experimental group compared with 37.5% of women in the placebo group. Estrone decreased in 55.56% of women in the experimental group compared with 42.86% in the placebo group. Those women in the experimental group who were consuming soy had their mean menstrual cycle length increased by 3.52 days compared with a mean decrease of 0.06 days for women in the placebo group (P = 0.04) from baseline to the third menstrual cycle. In addition, women who were taking soy had their mean follicular phase increase by 1.46 days compared with a mean increase of 0.14 days for women who were taking the placebo (P = 0.08). CONCLUSIONS: These data suggest that increased isoflavone intake affects estrogen metabolism by altering the steroid hormone concentrations and menstrual cycle length, thereby demonstrating a potential to reduce the risk for breast carcinoma.