A phase 2 randomized controlled trial of oral resistant starch supplements in the prevention of acute radiation proctitis in patients treated for cervical cancer.

BACKGROUND: Radiation induced proctitis is frequently encountered during the radiation therapy of cervical and prostate cancers that causes pain and occasionally with bleeding and may affect the continuity of radiation therapy. AIMS AND OBJECTIVES: The purpose of the study is to look at the benefit of administration of an oral prebiotic amylase resistant starch in reducing the incidence of acute radiation proctitis, a distressing symptom in patients receiving radiation therapy for cancer of the cervix. MATERIAL AND METHODS: The study was conducted between 2011 and 2014 in 104 patients receiving radical chemo-radiotherapy for carcinoma cervix. Patients were randomized in to two arms, one receiving 30 gm of resistant starch and the other digestible starch on a daily basis throughout the course of the external radiotherapy. All patients received standard 4-field box radiation portals, 50 Gy in 25 fractions with 4 cycles of weekly concurrent Cisplatin. At completion of external beam radiotherapy, all patients underwent LDR/HDR brachytherapy. The study was double blinded and allocation was concealed from the investigators. The investigator recorded the radiotherapy related toxicity of the patients according to CTC V 3.0. The incidence and severity of grade 2-4 diarrhoea and proctitis were documented on a weekly basis and compared across the two groups and analyzed. Stool short chain fatty acid concentrations were measured at baseline at 2nd and 4th week and after 6 weeks of completion of radiotherapy in both study placebo arms and reported. The pattern of microbiota in the stool were also estimated in all patients at 4 time points. Two patients who progressed during therapy were not included in the analyses and two patients discontinued the intervention. A per protocol analyses was done. RESULTS: At analysis there were 50 patients in each arm. The severity of clinical proctitis was found to be similar in both groups of patients with 12.2 % of patients experiencing toxicity of grade 2 and above in digestible starch group versus 14.6% in the resistant starch group. Functional proctitis was similarly graded and it was found that 16.3 % patients in digestible starch group experienced toxicity against 10.2 % patients in the resistant starch group. This difference was seen at 4th week and continued in the subsequent weeks till the end of radiation. Both groups had similar reported toxicity at 6 weeks post intervention and similar incidence of grade 2 and above diarrhea. The resistant starch group was found to have 8% incidence as compared to 2% in the other group at the 5th and 6th week. The short chain fatty acid concentrations were not significantly different in the groups at any point. CONCLUSION: The study did not demonstrate a significant benefit in administering resistant starch over and above normal diet to patients receiving pelvic radiotherapy. The reasons may be attributed to concurrent use of chemotherapy and decrease in intestinal probiotics. The use of digestible starch in the control arm may have contributed to lower incidence of the toxicity endpoints as well.

High index of clinical suspicion with optimal surgical techniques and adjuvant radiotherapy is critical to reduce locoregional disease progression in parathyroid carcinoma.

AIMS: We have analyzed the risk factors and the impact of external beam radiotherapy (EBRT) in reducing the locoregional recurrence of parathyroid carcinoma (PTC). METHODS: Various parameters such as clinical presentation, intraoperative findings, surgical methods, and usage of parafibromin were analyzed. Selected endpoints were locoregional progression-free survival and overall survival. RESULTS: Three patients had local recurrence. Two of them received EBRT after the first recurrence but continued to have local recurrence. One patient was lost to follow-up. Six patients with EBRT remain asymptomatic with a locoregional progression-free survival and overall survival of 42 months. The presence of a palpable nodule in the neck, serum calcium >14 mg/dL, and intraoperative substrap adhesion (OR=9.3, 95% confidence interval, 1.76-56.1; P<0.05) should raise suspicion. Four of 5 patients showed a predominantly negative staining with parafibromin. CONCLUSIONS: PTC should be suspected in the preoperative and intraoperative period. EBRT may reduce local recurrence by 65%. Parafibromin staining with no more than 0 to 1+ intensity in 80% to 100% of cells can predict carcinoma with specificity up to 100%.

Influence of deep breathing exercise on spontaneous respiratory rate and heart rate variability: a randomised controlled trial in healthy subjects.

Studies show that yogic type of breathing exercises reduces the spontaneous respiratory rate. However, there are no conclusive studies on the effects of breathing exercise on heart rate variability. We investigated the effects of non-yogic breathing exercise on respiratory rate and heart rate variability. Healthy subjects (21-33 years, both genders) were randomized into the intervention group (n=18), which performed daily deep breathing exercise at 6 breaths/min (0.1 Hz) for one month, and a control group (n=18) which did not perform any breathing exercise. Baseline respiratory rate and short-term heart rate variability indices were assessed in both groups. Reassessment was done after one month and the change in the parameters from baseline was computed for each group. Comparison of the absolute changes [median (inter-quartile ranges)] of the parameters between the intervention and control group showed a significant difference in the spontaneous respiratory rate [intervention group -2.50 (-4.00, -1.00), control group 0.00 (-1.00, 1.00), cycles/min, P<0.001], mean arterial pressure [intervention group -0.67 (-6.67, 1.33), control group 0.67 (0.00, 6.67), mmHg, (P<0.05)], high frequency power [intervention group 278.50 (17.00, 496.00), control group -1.00 (-341.00, 196.00), ms2 P<0.05] and sum of low and high frequency powers [intervention group 512.00 (-73.00, 999.00), control group 51.00 (-449.00, 324.00), ms2, P<0.05]. Neither the mean of the RR intervals nor the parameters reflecting sympatho-vagal balance were significantly different across the groups. In conclusion, the changes produced by simple deep slow breathing exercise in the respiratory rate and cardiac autonomic modulation of the intervention group were significant, when compared to the changes in the control group. Thus practice of deep slow breathing exercise improves heart rate variability in healthy subjects, without altering their cardiac autonomic balance. These findings have implications in the use of deep breathing exercises to improve cardiac autonomic control in subjects known to have reduced heart rate variability.

The effects of 'on-call/out of hours' physical therapy in acute exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial.

OBJECTIVE: To assess the effectiveness of an on-call physical therapy programme in the management of acute exacerbations of chronic obstructive pulmonary diseases. DESIGN: Randomized controlled trial. SETTING: Secondary care level, rural hospital. SUBJECTS: Thirty-eight patients with acute exacerbations of chronic obstructive pulmonary disease. INTERVENTIONS: Regular physical therapy and on-call physical therapy was given to two groups of patients with 19 in each arm. On-call physical therapy included providing respiratory physical therapy as required by the patient out of business hours. MAIN MEASURES: Peak expiratory flow rate, sustained maximal inspiration, six-minute walk distance and rating of perceived exertion post six-minute walk test. RESULTS: In the group receiving on-call physical therapy, peak expiratory flow rate and six-minute walk test showed a significant difference (52.1 L/min and 98.16 m, respectively) when compared with the control group (211.57 +/- 51.12 L/min and 159.47 +/- 67.78 L/min; P =0.01 and 387.89 +/- 110.1 m and 289.73 +/- 103.2 m; P=0.004 respectively). The difference in peak expiratory flow rate (Delta peak expiratory flow rate) was seen to be more in the on-call group (120 L/min) when compared to the control group (50 L/min), P =0.002. Improvements in sustained maximal inspiration and Borg's rating of perceived exertion after the six-minute walk test were also observed (P>0.05). CONCLUSION: On-call physical therapy brings about a significant increase in peak expiratory flow rates, six-minute walk distance and sustained maximal inspiration.

Comparison of group counseling with individual counseling in the comprehension of informed consent: a randomized controlled trial.

BACKGROUND: Studies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent. METHODS: Parents of children participating in a trial of nutritional supplementation were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents. RESULTS: A total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm. CONCLUSIONS: The results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.