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Gillian M Duchesne - One of the best experts on this subject based on the ideXlab platform.

  • RESEARCH Open Access Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy
    2013
    Co-Authors: Suki Gill, Jessica Thomas, Chris Fox, Tomas Kron, Aldo Rolfo, Mary Leahy, Scott Williams, Keen Hun Tai, Gillian M Duchesne
    Abstract:

    Background: Image-guided radiotherapy (IGRT) increases the accuracy of treatment delivery through daily target localisation. We report on toxicity symptoms experienced during radiotherapy treatment, with and without IGRT in prostate cancer patients treated radically. Methods: Between 2006 and 2009, acute toxicity data for ten symptoms were collected prospectively onto standardized assessment forms. Toxicity was scored during radiotherapy, according to the Common Terminology Criteria Adverse Events V3.0, for 275 prostate cancer patients before and after the implementation of a fiducial marker IGRT program and dose escalation from 74Gy in 37 fractions, to 78Gy in 39 fractions. Margins and planning constraints were maintained the same during the study period. The symptoms scored were urinary frequency, cystitis, bladder spasm, urinary incontinence, urinary retention, diarrhoea, haemorrhoids, proctitis, anal Skin Discomfort and fatigue. Analysis was conducted for the maximum grade of toxicity and the median number of days from the onset of that toxicity to the end of treatment. Results: In the IGRT group, 14228 toxicity scores were analysed from 249 patients. In the non-IGRT group, 1893 toxicity scores were analysed from 26 patients. Urinary frequency ≥G3 affected 23 % and 7 % in the non-IGRT and IGRT group respectively (p = 0.0188). Diarrhoea ≥G2 affected 15 % and 3 % of patients in the non-IGRT and IGR

  • acute toxicity in prostate cancer patients treated with and without image guided radiotherapy
    Radiation Oncology, 2011
    Co-Authors: Suki Gill, Jessica Thomas, Tomas Kron, Aldo Rolfo, Mary Leahy, Scott Williams, Gillian M Duchesne, Sarat Chander
    Abstract:

    Background: Image-guided radiotherapy (IGRT) increases the accuracy of treatment delivery through daily target localisation. We report on toxicity symptoms experienced during radiotherapy treatment, with and without IGRT in prostate cancer patients treated radically. Methods: Between 2006 and 2009, acute toxicity data for ten symptoms were collected prospectively onto standardized assessment forms. Toxicity was scored during radiotherapy, according to the Common Terminology Criteria Adverse Events V3.0, for 275 prostate cancer patients before and after the implementation of a fiducial marker IGRT program and dose escalation from 74Gy in 37 fractions, to 78Gy in 39 fractions. Margins and planning constraints were maintained the same during the study period. The symptoms scored were urinary frequency, cystitis, bladder spasm, urinary incontinence, urinary retention, diarrhoea, haemorrhoids, proctitis, anal Skin Discomfort and fatigue. Analysis was conducted for the maximum grade of toxicity and the median number of days from the onset of that toxicity to the end of treatment. Results: In the IGRT group, 14228 toxicity scores were analysed from 249 patients. In the non-IGRT group, 1893 toxicity scores were analysed from 26 patients. Urinary frequency ≥G3 affected 23% and 7% in the non-IGRT and IGRT group respectively (p = 0.0188). Diarrhoea ≥G2 affected 15% and 3% of patients in the non-IGRT and IGRT groups (p = 0.0174). Fatigue ≥G2 affected 23% and 8% of patients in the non-IGRT and IGRT groups (p = 0.0271). The median number of days with a toxicity was higher for ≥G2 (p = 0.0179) and ≥G3 frequency (p = 0.0027), ≥G2 diarrhoea (p = 0.0033) and ≥G2 fatigue (p = 0.0088) in the non-IGRT group compared to the IGRT group. Other toxicities were not of significant statistical difference. Conclusions: In this study, prostate cancer patients treated radically with IGRT had less severe urinary frequency, diarrhoea and fatigue during treatment compared to patients treated with non-IGRT. Onset of these symptoms was earlier in the non-IGRT group. IGRT results in less acute toxicity during radiotherapy in prostate cancer.

Nikos Evangelou - One of the best experts on this subject based on the ideXlab platform.

  • hookworm treatment for relapsing multiple sclerosis a randomized double blinded placebo controlled trial
    JAMA Neurology, 2020
    Co-Authors: Radu Tanasescu, Christopher R Tench, Cris S Constantinescu, Gary Telford, Sonika Singh, Nanci Frakich, David Onion, Dorothee P Auer, Bruno Gran, Nikos Evangelou
    Abstract:

    Importance Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). To our knowledge, there are no controlled treatment trials with helminth in MS. Objective To determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS. Design, Setting, and Participants This 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen’s Medical Centre, a single tertiary referral center. Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined). Interventions Patients were randomized (1:1) to receive either 25Necator americanuslarvae transcutaneously or placebo. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment. Main Outcomes and Measures The primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood. Results Patients (mean [SD] age, 45 [9.5] years; 50 women [71%]) were randomized to receive hookworm (35 [49.3%]) or placebo (36 [50.7%]). Sixty-six patients (93.0%) completed the trial. The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-WhitneyUtests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 [51.4%] vs 10/36 [27.8%] in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%];P = .01). No patients withdrew because of adverse effects. There were no differences in adverse events between groups except more application-site Skin Discomfort in the hookworm group (82% vs 28%). There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo. Conclusions and Relevance Treatment with hookworm was safe and well tolerated. The primary outcome did not reach significance, likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity. Trial Registration ClinicalTrials.gov Identifier:NCT01470521

Falah Yasser - One of the best experts on this subject based on the ideXlab platform.

  • Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial
    'American Medical Association (AMA)', 2020
    Co-Authors: Tanasescu Radu, Tench, Christopher R, Constantinescu, Cris S, Telford Gary, Frakich Nanci, Onion David, Auer, Dorothee P, Gran Bruno, Evangelou Nikos, Falah Yasser
    Abstract:

    © 2020 American Medical Association. All rights reserved. Importance: Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). To our knowledge, there are no controlled treatment trials with helminth in MS. Objective: To determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS. Design, Setting, and Participants: This 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center. Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined). Interventions: Patients were randomized (1:1) to receive either 25 Necator americanus larvae transcutaneously or placebo. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment. Main Outcomes and Measures: The primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood. Results: Patients (mean [SD] age, 45 [9.5] years; 50 women [71%]) were randomized to receive hookworm (35 [49.3%]) or placebo (36 [50.7%]). Sixty-six patients (93.0%) completed the trial. The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-Whitney U tests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 [51.4%] vs 10/36 [27.8%] in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P =.01). No patients withdrew because of adverse effects. There were no differences in adverse events between groups except more application-site Skin Discomfort in the hookworm group (82% vs 28%). There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo. Conclusions and Relevance: Treatment with hookworm was safe and well tolerated. The primary outcome did not reach significance, likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity. Trial Registration: ClinicalTrials.gov Identifier: NCT01470521

Tanasescu Radu - One of the best experts on this subject based on the ideXlab platform.

  • Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial.
    'Organisation for Economic Co-Operation and Development (OECD)', 2020
    Co-Authors: Tanasescu Radu, Tench, Christopher R, Constantinescu, Cris S, Telford Gary, Singh Sonika, Frakich Nanci, Onion David, Auer, Dorothee P, Gran Bruno, Evangelou Nikos
    Abstract:

    IMPORTANCE: Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). There are no controlled treatment trials with helminth in MS. OBJECTIVE: To determine whether hookworm treatment has effects on MRI activity and T regulatory cells in relapsing MS. DESIGN: 9-month double-blind, randomised, placebo-controlled trial conducted between 2012-2016; analysis as per 06.2018. SETTING: University of Nottingham, Queen’s Medical Centre. Single tertiary referral center. PARTICIPANTS: Patients aged 18-61 with relapsing MS without disease-modifying-treatment were recruited from the MS Clinic. 73 patients were screened, 71 were recruited (2 ineligible/declined). INTERVENTION: Patients were randomised (1:1) to either 25 Necator americanus larvae transcutaneously or placebo. MRI scans were performed monthly during months 3-9, and 3-months post-treatment. MAIN OUTCOMES AND MEASURES: The primary endpoint was the cumulative number of new/enlarging T2/new enhancing-T1 lesions at month 9. The secondary endpoint was the percentage of CD4+CD25highCD127negT regulatory cells in peripheral blood. RESULTS: Patients (mean age:45;71%-female) were randomized to hookworm (35) or placebo (36). 66 patients completed the trial. Median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups, by pre-planned Mann-Whitney which loses power with tied data (high number of zero activity MRIs in the hookworm group, 18/35 vs. 10/36 in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (p=0.013; hookworm:4.4;n=32; placebo:3.9;n=34). No patients withdrew because of adverse effects. There were no differences in adverse events between groups, except more application-site Skin Discomfort in the hookworm group (82% vs. 28%). There were 5 relapses in the hookworm group vs. 11 on placebo. CONCLUSIONS AND RELEVANCE: Treatment with hookworm was safe and well-tolerated. The primary outcome did not reach significance, in part likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may impact MS disease activity. TRIAL REGISTRATION: ClinicalTrials.govNCT0147052

  • Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial
    'American Medical Association (AMA)', 2020
    Co-Authors: Tanasescu Radu, Tench, Christopher R, Constantinescu, Cris S, Telford Gary, Frakich Nanci, Onion David, Auer, Dorothee P, Gran Bruno, Evangelou Nikos, Falah Yasser
    Abstract:

    © 2020 American Medical Association. All rights reserved. Importance: Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). To our knowledge, there are no controlled treatment trials with helminth in MS. Objective: To determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS. Design, Setting, and Participants: This 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center. Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined). Interventions: Patients were randomized (1:1) to receive either 25 Necator americanus larvae transcutaneously or placebo. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment. Main Outcomes and Measures: The primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood. Results: Patients (mean [SD] age, 45 [9.5] years; 50 women [71%]) were randomized to receive hookworm (35 [49.3%]) or placebo (36 [50.7%]). Sixty-six patients (93.0%) completed the trial. The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-Whitney U tests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 [51.4%] vs 10/36 [27.8%] in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P =.01). No patients withdrew because of adverse effects. There were no differences in adverse events between groups except more application-site Skin Discomfort in the hookworm group (82% vs 28%). There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo. Conclusions and Relevance: Treatment with hookworm was safe and well tolerated. The primary outcome did not reach significance, likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity. Trial Registration: ClinicalTrials.gov Identifier: NCT01470521

Evangelou Nikos - One of the best experts on this subject based on the ideXlab platform.

  • Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial.
    'Organisation for Economic Co-Operation and Development (OECD)', 2020
    Co-Authors: Tanasescu Radu, Tench, Christopher R, Constantinescu, Cris S, Telford Gary, Singh Sonika, Frakich Nanci, Onion David, Auer, Dorothee P, Gran Bruno, Evangelou Nikos
    Abstract:

    IMPORTANCE: Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). There are no controlled treatment trials with helminth in MS. OBJECTIVE: To determine whether hookworm treatment has effects on MRI activity and T regulatory cells in relapsing MS. DESIGN: 9-month double-blind, randomised, placebo-controlled trial conducted between 2012-2016; analysis as per 06.2018. SETTING: University of Nottingham, Queen’s Medical Centre. Single tertiary referral center. PARTICIPANTS: Patients aged 18-61 with relapsing MS without disease-modifying-treatment were recruited from the MS Clinic. 73 patients were screened, 71 were recruited (2 ineligible/declined). INTERVENTION: Patients were randomised (1:1) to either 25 Necator americanus larvae transcutaneously or placebo. MRI scans were performed monthly during months 3-9, and 3-months post-treatment. MAIN OUTCOMES AND MEASURES: The primary endpoint was the cumulative number of new/enlarging T2/new enhancing-T1 lesions at month 9. The secondary endpoint was the percentage of CD4+CD25highCD127negT regulatory cells in peripheral blood. RESULTS: Patients (mean age:45;71%-female) were randomized to hookworm (35) or placebo (36). 66 patients completed the trial. Median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups, by pre-planned Mann-Whitney which loses power with tied data (high number of zero activity MRIs in the hookworm group, 18/35 vs. 10/36 in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (p=0.013; hookworm:4.4;n=32; placebo:3.9;n=34). No patients withdrew because of adverse effects. There were no differences in adverse events between groups, except more application-site Skin Discomfort in the hookworm group (82% vs. 28%). There were 5 relapses in the hookworm group vs. 11 on placebo. CONCLUSIONS AND RELEVANCE: Treatment with hookworm was safe and well-tolerated. The primary outcome did not reach significance, in part likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may impact MS disease activity. TRIAL REGISTRATION: ClinicalTrials.govNCT0147052

  • Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial
    'American Medical Association (AMA)', 2020
    Co-Authors: Tanasescu Radu, Tench, Christopher R, Constantinescu, Cris S, Telford Gary, Frakich Nanci, Onion David, Auer, Dorothee P, Gran Bruno, Evangelou Nikos, Falah Yasser
    Abstract:

    © 2020 American Medical Association. All rights reserved. Importance: Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS). To our knowledge, there are no controlled treatment trials with helminth in MS. Objective: To determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS. Design, Setting, and Participants: This 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen's Medical Centre, a single tertiary referral center. Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Seventy-three patients were screened; of these, 71 were recruited (2 ineligible/declined). Interventions: Patients were randomized (1:1) to receive either 25 Necator americanus larvae transcutaneously or placebo. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment. Main Outcomes and Measures: The primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25highCD127negT regulatory cells in peripheral blood. Results: Patients (mean [SD] age, 45 [9.5] years; 50 women [71%]) were randomized to receive hookworm (35 [49.3%]) or placebo (36 [50.7%]). Sixty-six patients (93.0%) completed the trial. The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-Whitney U tests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 [51.4%] vs 10/36 [27.8%] in the placebo group). The percentage of CD4+CD25highCD127negT cells increased at month 9 in the hookworm group (hookworm, 32 [4.4%]; placebo, 34 [3.9%]; P =.01). No patients withdrew because of adverse effects. There were no differences in adverse events between groups except more application-site Skin Discomfort in the hookworm group (82% vs 28%). There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo. Conclusions and Relevance: Treatment with hookworm was safe and well tolerated. The primary outcome did not reach significance, likely because of a low level of disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity. Trial Registration: ClinicalTrials.gov Identifier: NCT01470521