A Feasibility Study of Restorative Yoga Versus Vigorous Yoga Intervention for Sedentary Breast and Ovarian Cancer Survivors.

Yoga has been shown to improve cancer survivors' quality of life, yet regular yoga practice is a challenge for those who are sedentary. We conducted a pilot randomized controlled study to assess feasibility and adherence of two types of yoga intervention among sedentary cancer survivors. Sedentary breast and ovarian cancer survivors were randomized to practice either restorative yoga (minimal physical exertion, Group R) or vigorous yoga (considerable physical exertion, Group V) in three 60-minute supervised sessions a week for 12 weeks, followed by 12 weeks of home practice. Accrual, adherence, and attendance rates were assessed. Of the 226 eligible patients, 175 (77%) declined to participate in the study, citing time commitment and travel as the most common barriers. Forty-two subjects consented to participate in the study. Of the 35 participants who began the intervention (20 in Group R and 15 in Group V), adherence rate (percentage remaining in the study at week 12) was 100% and 87%, respectively. Rate of adequate attendance (more than 66% of the scheduled supervised sessions) was 85% and 73%, respectively. Rate of completion of the home practice period was 85% and 77%, respectively. In this study, sedentary cancer survivors were able to adhere to a long-term, regular yoga regimen. The rate of adequate attendance was higher for restorative yoga. Future studies for sedentary patients should focus on reducing time commitment and travel requirements to improve recruitment, and on using restorative yoga as a more feasible intervention for this population.

Acupuncture for reduction of symptom burden in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation: a randomized sham-controlled trial.

PURPOSE: Hematopoietic stem cell transplantation (HCT) is potentially curative for a number of hematologic malignancies, but is associated with high symptom burden. We conducted a randomized sham-controlled trial (RCT) to evaluate efficacy and safety of acupuncture as an integrative treatment for managing common symptoms during HCT. METHODS: Adult patients with multiple myeloma undergoing high-dose melphalan followed by autologous HCT (AHCT) were randomized to receive either true or sham acupuncture once daily for 5 days starting the day after chemotherapy. Patients and clinical evaluators, but not acupuncturists, were blinded to group assignment. Symptom burden, the primary outcome was assessed with the MD Anderson Symptom Inventory (MDASI) at baseline, during transplantation, and at 15 and 30 days post transplantation. RESULTS: Among 60 participants, true acupuncture produced nonsignificant reductions in overall MDASI core symptom scores and symptom interference scores during transplantation (P = .4 and .3, respectively), at 15 days (P = .10 and .3), and at 30 days posttransplantation (P = .2 and .4) relative to sham. However, true acupuncture was significantly more efficacious in reducing nausea, lack of appetite, and drowsiness at 15 days (P = .042, .025, and .010, respectively). Patients receiving sham acupuncture were more likely to increase pain medication use posttransplantation (odds ratio 5.31, P = .017). CONCLUSIONS: Acupuncture was well tolerated with few attributable adverse events. True acupuncture may prevent escalation of symptoms including nausea, lack of appetite, and drowsiness experienced by patients undergoing AHCT, and reduce the use of pain medications. These findings need to be confirmed in a future definitive study. TRIAL REGISTRATION: NCT01811862.

Serum 25-hydroxy vitamin D and survival in advanced colorectal cancer: a retrospective analysis.

Higher serum 25-hydroxy vitamin D [25(OH)D] levels are associated with decreased colorectal cancer (CRC) incidence. In this retrospective study of Stage IV CRC patients, we evaluate whether 25(OH)D levels at diagnosis correlate with survival. Stored sera from carcinoembryonic antigen (CEA) measurements obtained between February 2005 and March 2006 were screened. The first 250 patients with CEA ± 30 days of Stage IV CRC diagnosis were included. Serum 25(OH)D levels were determined and categorized as adequate ≥ 30 ng/mL, or deficient <30 ng/mL. Multivariable Cox regression models controlling for albumin and Eastern Cooperative Oncology Group performance status were used to investigate whether higher 25(OH)D levels were associated with prolonged survival. A total of 207 patients (83%) were vitamin D-deficient (median = 21 ng/mL), with deficiencies significantly more likely among non-Hispanic black patients (P = 0.009). Higher levels were associated with prolonged survival in categorical variable analysis: adequate vs. deficient, hazard ratio = 0.61, 95% confidence interval = 0.38-0.98, P = 0.041. A majority of newly diagnosed Stage IV CRC patients are vitamin D-deficient. Our data suggest that higher 25(OH)D levels are associated with better overall survival. Clinical trials to determine whether aggressive vitamin D repletion would improve outcomes for vitamin D-deficient CRC patients are warranted.

Maitake mushroom extract in myelodysplastic syndromes (MDS): a phase II study.

BACKGROUND: Myelodysplastic syndromes (MDS) are characterized by ineffective erythropoiesis with dysplastic bone marrow leading to peripheral cytopenia, risk of infection, and progression to acute myelogenous leukemia. Maitake mushroom beta-glucan, a dietary supplement, stimulates hematopoietic progenitor cell differentiation, granulocyte colony-stimulating factor production, and recovery of peripheral blood leukocytes after bone marrow injury. This phase II trial examined the effects of Maitake on innate immune function in MDS. METHODS: Myelodysplastic syndromes patients with International Prognostic Scoring System Low- and Intermediate-1-risk disease received oral Maitake extract at 3 mg/kg twice daily for 12 weeks. Primary endpoints included neutrophil count and function tested as endogenous or stimulated neutrophil production of reactive oxygen species (ROS) by flow cytometry compared with age-matched healthy controls (HC). ROS activators were Escherichia coli, phorbol ester, and the bacterial peptide N-formylmethionyl-leucyl-phenylalanine (fMLP). Complete blood counts, chemistry panels, iron studies, and monocyte function were evaluated. RESULTS: Of 21 patients enrolled, 18 completed the study and were evaluable. Maitake increased endogenous (basal) neutrophil (p = 0.005) and monocyte function (p = 0.021). Pre-treatment monocyte response to E. coli was reduced in MDS patients compared with HC (p = 0.002) and increased (p = 0.0004) after treatment. fMLP-stimulated ROS production response also increased (p = 0.03). Asymptomatic eosinophilia occurred in 4 patients (p = 0.014). Other changes in albumin, hemoglobin, and total protein were not clinically relevant. CONCLUSIONS: Maitake was well tolerated. Enhanced in vitro neutrophil and monocyte function following treatment demonstrate that Maitake has beneficial immunomodulatory potential in MDS. Further study is warranted.

Adherence in a 1-year whole foods eating pattern intervention with healthy postmenopausal women.

OBJECTIVE: To determine the degree of dietary adherence or change in eating patterns, and demographic, psychosocial and study characteristics associated with adherence, in the Comparing Healthy Options in Cooking and Eating (CHOICE) Study. DESIGN: Randomized controlled trial where women were randomized to one of three eating patterns: (i) Whole Foods, plant-based, macrobiotic-style (n 22); and Moderate Fat with (ii), and without (iii), 10 g of ground flaxseed added daily, which were combined (n 49). SETTING: A year-long intervention based on social cognitive theory, consisting of twenty-four class sessions involving hands-on cooking classes and behavioural sessions. Monthly 24 h food recalls were obtained and a psychosocial questionnaire was administered at baseline, 6 and 12 months. SUBJECTS: Healthy, free-living, postmenopausal women. RESULTS: A non-adherence score measuring all food servings out-of-compliance with eating pattern recommendations was specifically designed for the present study. Non-adherence scores decreased significantly (P < 0·05) in both groups to about 65 % during the adoption phase (first 4 months) and remained so during the 8-month maintenance period. Class attendance of the Moderate Fat group showed a trend towards significance as a predictor of adherence (P = 0·063). None of the other predictors (e.g. demographic and psychosocial factors) in a longitudinal regression model were significant. CONCLUSIONS: Postmenopausal women were able to adopt and maintain significant changes in their eating patterns, including those on a demanding, near-vegetarian eating plan, suggesting that behavioural interventions with a healthy free-living population can be effective. The non-adherence score developed for the study provides an example of a means for evaluating eating pattern adherence to a dietary intervention.

Acupuncture in the treatment of upper-limb lymphedema: results of a pilot study.

BACKGROUND: Current treatments for lymphedema after breast cancer treatment are expensive and require ongoing intervention. Clinical experience and our preliminary published results suggest that acupuncture is safe and potentially useful. This study evaluates the safety and potential efficacy of acupuncture on upper-limb circumference in women with lymphedema. METHODS: Women with a clinical diagnosis of breast cancer-related lymphedema (BCRL) for 0.5-5 years and with affected arm circumference ≥2 cm larger than unaffected arm received acupuncture treatment twice weekly for 4 weeks. Affected and unaffected arm circumferences were measured before and after each acupuncture treatment. Response, defined as ≥30% reduction in circumference difference between affected/unaffected arms, was assessed. Monthly follow-up calls for 6 months thereafter were made to document any complications and self-reported lymphedema status. RESULTS: Among 37 enrolled patients, 33 were evaluated; 4 discontinued due to time constraints. Mean reduction in arm circumference difference was 0.90 cm (95% CI, 0.72-1.07; P < .0005). Eleven patients (33%) exhibited a reduction of ≥30% after acupuncture treatment. Seventy-six percent of patients received all treatments; 21% missed 1 treatment, and another patient missed 2 treatments. During the treatment period, 14 of the 33 patients reported minor complaints, including mild local bruising or pain/tingling. There were no serious adverse events and no infections or severe exacerbations after 255 treatment sessions and 6 months of follow-up interviews. CONCLUSIONS: Acupuncture for BCRL appears safe and may reduce arm circumference. Although these results await confirmation in a randomized trial, acupuncture can be considered for women with no other options for sustained arm circumference reduction.

A phase II, randomized, controlled trial of acupuncture for reduction of Postcolectomy Ileus.

PURPOSE: Postoperative ileus (POI) prolongs hospital stay and increases risk of postoperative complications. We conducted a randomized, sham-controlled trial to evaluate whether acupuncture reduces POI more effectively than sham acupuncture. METHODS: Colon cancer patients undergoing elective colectomy were randomized to receive 30 min of true or sham acupuncture twice daily during their first 3 postoperative days. GI-3 (the later of the following two events: time that the patient first tolerated solid food, AND time that the patient first passed flatus OR a bowel movement) and GI-2 (the later of the following two events: time patient first tolerated solid food AND time patient first passed a bowel movement) were determined. Pain, nausea, vomiting, and use of pain medications were evaluated daily for the first 3 postoperative days. RESULTS: Ninety patients were randomized. Eighty-one received the allocated intervention: 39 in the true acupuncture group and 42 in the sham acupuncture group, all evaluated for the primary endpoint. The mean time to GI-3 was 149 h [standard deviation (SD) 71 h] and 146 (SD 62 h) after surgery for the acupuncture group and the sham acupuncture group (difference between means -2 h; 95 % confidence interval -31, 26; p = 0.9). No significant differences were found between groups for secondary endpoints. CONCLUSIONS: True acupuncture as provided in this study did not reduce POI more significantly than sham acupuncture. The study was limited by a standard deviation much larger than expected, suggesting that a study with a larger sample size might be required.

A safety and efficacy pilot study of acupuncture for the treatment of chronic lymphoedema.

BACKGROUND: Lymphoedema is a distressing problem affecting many women after breast cancer surgery. There is no cure and existing treatments are marginally beneficial, rarely reducing arm swelling in any meaningful way. Needling and even lifting of objects using the affected arm has been prohibited, but our clinical experience and that of others suggested that acupuncture was safe and that it might be a useful treatment for lymphoedema. OBJECTIVE: We sought to conduct a pilot study of the safety and effectiveness of acupuncture in women diagnosed with chronic lymphoedema for at least 6 months and less than 5 years. METHODS: Women with chronic lymphoedema (affected arm with >2 cm circumference than unaffected arm) after breast cancer surgery received acupuncture twice a week for 4 weeks. Response was defined as at least a 30% reduction in the difference in size between the affected and unaffected arms. Monthly follow-up calls for 6 months following treatment were made to obtain information about side effects. RESULTS: Study goals were met after nine subjects were treated: four women showed at least a 30% reduction in the extent of lymphoedema at 4 weeks when compared with their respective baseline values. No serious adverse events occurred during or after 73 treatment sessions. Limitations This pilot study requires a larger, randomised follow-up investigation plus enquiries into possible mechanisms. Both are in development by our group. CONCLUSION: Acupuncture appears safe and may reduce lymphoedema associated with breast cancer surgery.

Safety and pharmacokinetic trial of docetaxel plus an Astragalus-based herbal formula for non-small cell lung cancer patients.

PURPOSE: To study a commonly used Astragalus-based herbal formula previously found effective in non-small cell lung cancer (NSCLC) on the pharmacokinetics of docetaxel in patients with NSCLC. METHODS: Patients with advanced NSCLC who progressed after prior platinum-containing chemotherapy were accrued and received docetaxel at 35 mg/m(2) for 3 weeks followed by 1 week of rest. At 4 days prior to the second dosing, Jinfukang was given orally. Pharmacokinetic studies of initial-dose docetaxel (in the absence of Jinfukang) and the third dose (in the presence of Jinfukang) were compared. RESULTS: Of the 24 patients enrolled, 21 started Jinfukang and docetaxel. Jinfukang had no significant impact on the pharmacokinetics of docetaxel. Median time to progression or withdrawal from treatment was 7 weeks. Twelve patients were removed from study for progression of disease; nine patients withdrew. CONCLUSIONS: Jinfukang did not alter the pharmacokinetics of docetaxel nor appear to affect survival in this study.