A randomized double-blind placebo-controlled cross-over trial of the impact on quality of life of continuing dexamethasone beyond 24 h following adjuvant chemotherapy for breast cancer

2012 ◽  
Vol 136 (1) ◽  
pp. 143-151 ◽  
Author(s):  
J. Vardy ◽  
G. Pond ◽  
A. Dodd ◽  
D. Warr ◽  
B. Seruga ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Chemotherapy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Impact

scholarly journals 0199 The impact of adjuvant chemotherapy on quality of life in women with early breast cancer

The Breast ◽  
2009 ◽  
Vol 18 ◽  
pp. S69
Author(s):  
G. Bulotiene ◽  
V. Ostapenko
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
The Impact

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women- The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical rating scale of pain (ENS NRS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS NRS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show approximately 30% relative risk reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion Ropivacaine is a promising candidate drug, inexpensive, easy to administer, and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

scholarly journals The Effect of CoQ10 Supplementation on Quality of Life in Women with Breast Cancer Undergoing Tamoxifen Therapy: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial

2020 ◽  
Vol Volume 13 ◽  
pp. 151-159
Author(s):  
Seyed Ahmad Hosseini ◽  
Nazanin Zahrooni ◽  
Ahmad Ahmadzadeh ◽  
Kambiz Ahmadi angali ◽  
Mohammad Ali Assarehzadegan
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Tamoxifen Therapy ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Coq10 Supplementation

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair - The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already showed the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and quality of life at mid- and long-term before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical scale of pain (ENS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show a 30% reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. Ropivacaine was a promising candidate drug, inexpensive, easy to administer, and easy to add on the routine management of deliveries in labor ward.

The Impact of Age on Quality of Life in Breast Cancer Patients Receiving Adjuvant Chemotherapy: A Comparative Analysis From the Prospective Multicenter Randomized ADEBAR trial

2017 ◽  
Vol 17 (2) ◽  
pp. 100-106 ◽  
Author(s):  
Elena Leinert ◽  
Susanne Singer ◽  
Wolfgang Janni ◽  
Nadia Harbeck ◽  
Tobias Weissenbacher ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Comparative Analysis ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
The Impact

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair - The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial

2019 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already showed the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and quality of life at mid- and long-term before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical scale of pain (ENS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show a 30% reduction in the incidence of perineal pain at day 7, from 70.0% to 50.0%. Discussion This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy. Ropivacaine was a promising candidate drug, inexpensive, easy to administer, and easy to add on the routine management of deliveries in labor ward.

ASTER 70s: Benefit of adjuvant chemotherapy for estrogen receptor-positive HER2-negative breast cancer in women over 70 according to genomic grade—A French GERICO/UCBG UNICANCER multicenter phase III trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS667-TPS667
Author(s):  
Etienne Brain ◽  
Veronique Girre ◽  
Florence Rollot ◽  
Franck Bonnetain ◽  
Marc Debled ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Adjuvant Chemotherapy ◽  
Competing Risks ◽  
Pegylated Liposomal Doxorubicin ◽  
Hormonal Treatment ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
The Impact

TPS667 Background: The benefit of adjuvant chemotherapy (CT) is highly controversial for elderly breast cancer (BC) women presenting with an oestrogen receptor-positive (ER+) HER2-negative (HER2-) phenotype. Conversely to hormonal treatment (HT) that remains the cornerstone of adjuvant treatment for such luminal tumours, CT may severely decompensate comorbidities and alter quality of life in elderly patients. As disappointing as it is in drug development, elderly have been constantly excluded from trials evaluating new modern prognosis classifiers. This prospective multicentre trial funded by a French national grant (PHRC 2011) is the first phase III trial to investigate the impact on overall survival (OS) of adjuvant CT in elderly ER+ HER2- BC patients selected with a modern prognosis classifier and taking into account competing risks for mortality (EudraCT 2011-004744-22). Methods: Following surgery, 2,000 women 70+ with ER+ HER2- BC (any pT/pN), will have a genomic grade (GG, derived from frozen MapQuantDx™, Ipsogen) centrally assessed on formalin-fixed paraffin-embedded samples. Only those with a high GG (estimation~700) will be randomized between HT alone vs CT followed by HT. CT regimen is left to the choice of investigators amongst 3 regimen of same duration [4 q3w cycles, docetaxel+cyclophosphamide, doxorubicin or non pegylated liposomal doxorubicin (Myocet)+cyclophosphamide, all with G-CSF], as well as HT (aromatase inhibitor±tamoxifen). Those with low GG or not included for other reasons (estimation~1,300) will be followed as an observational parallel cohort with HT alone. Sample size is based on 4-year OS as primary endpoint (87.5 vs 80%), bilateral α=0.05, β=0.20 and HR= 0.60. Secondary endpoints include assessment of competing risks for mortality, cost-effectiveness and Q-TWiST analysis, geriatric items (e.g. Lee’s 4-year mortality score and G8 screening tool), acceptability, quality of life (QLQ-C30 and specific elderly scale ELD15), and translational research on ageing/prognostic biomarkers and pharmacogenetic. The trial has been just opened to inclusion in February 2012.

scholarly journals Ropivacaine 75mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair - The ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trial.

2020 ◽  
Author(s):  
Claire CARDAILLAC ◽  
Stéphane Ploteau ◽  
Aurélie Le Thuaut ◽  
Vincent Dochez ◽  
Norbert Winer ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Perineal Pain ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Mediolateral Episiotomy ◽  
The Impact

Abstract Background Perineal pain due to episiotomy is commonly reported and can be severe enough to disturb the mother-infant dyad during the postpartum period. Its incidence at day 7 postpartum varies from 63% to 74%. Recent studies have already showed-investigated the analgesic efficacy of perineal infiltration of ropivacaine after episiotomy, but have only focused on the immediate postpartum period (at 24 and 48 hours after birth). Large, adequately powered, multicenter, randomized controlled trials are required to evaluate the impact of ropivacaine infiltration on perineal pain and quality of life at mid- and long-term quality of life before the widespread use of ropivacaine to prevent perineal pain after episiotomy can be recommended. Methods The ROPISIO study is a two-center, randomized, double-blind, placebo-controlled trial in La Roche sur Yon and Nantes, France. It will involve 272 women with vaginal singleton delivery and mediolateral episiotomy at term (≥ 37 weeks). Perineal infiltration (ropivacaine 75mg or placebo) will be administrated just after vaginal birth and before episiotomy repair. The primary outcome will be the analgesic efficacy at day 7 postpartum (mid-term), defined by the numerical scale of pain (ENS) strictly superior to 3/10 on the perineal repair area. Secondary outcomes will be the analgesic efficacy (ENS), the impact of pain on daily behavior, on the quality of life (36-Item Short Form Health Survey), on the occurrence of symptoms of postpartum depression (Edinburgh Postnatal Depression Scale) and on sexuality (Female Sexual Function Index) at 3 and 6 months (long-term) using validated online questionnaires. This study will have 90% power to show a approximately 30% relative risk reduction in the incidence of perineal pain at day 7 from 70.0% to 50.0%. Discussion Ropivacaine was is a promising candidate drug, inexpensive, easy to administer, and easy to add on and would be suitable to include in the routine management of deliveries in labor ward. This study will investigate if perineal ropivacaine infiltration just after birth can reduce mid- and long-term postpartum pain and increase quality of life in women with mediolateral episiotomy.

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