What is the appropriate skin cleaning method for nasopharyngeal cancer radiotherapy patients? A randomized controlled trial

Purpose The contribution of adjuvant chemotherapy after chemoradiation therapy (CRT) in nasopharyngeal cancer (NPC) remains controversial. Plasma Epstein-Barr virus (EBV) DNA is a potential biomarker of subclinical residual disease in NPC. In this prospective, multicenter, randomized controlled trial, we used plasma EBV DNA to identify patients with NPC at a higher risk of relapse for adjuvant chemotherapy. Patients and Methods Eligible patients with histologically confirmed NPC of Union for International Cancer Control stage IIB to IVB, adequate organ function, and no locoregional disease or distant metastasis were screened by plasma EBV DNA at 6 to 8 weeks after radiotherapy (RT). Patients with undetectable plasma EBV DNA underwent standard surveillance. Patients with detectable plasma EBV DNA were randomly assigned to either adjuvant chemotherapy with cisplatin and gemcitabine for six cycles (arm 1) or observation (arm 2). Patients were stratified for primary treatment (RT v CRT) and stage (II/III v IV). The primary end point was relapse-free survival (RFS). Results Seven hundred eighty-nine patients underwent EBV DNA screening. Plasma EBV DNA was undetectable in 573 (72.6%) and detectable in 216 (27.4%); 104 (13.2%) with detectable EBV DNA were randomly assigned to arms 1 (n = 52) and 2 (n = 52). After a median follow-up of 6.6 years, no significant difference was found in 5-year RFS rate between arms 1 and 2 (49.3% v 54.7%; P = .75; hazard ratio for relapse or death, 1.09; 95% CI, 0.63 to 1.89). The level of post-RT plasma EBV DNA correlated significantly with the hazards of locoregional failure, distant metastasis, and death. Conclusion In patients with NPC with detectable post-RT plasma EBV DNA, adjuvant chemotherapy with cisplatin and gemcitabine did not improve RFS. Post-RT plasma EBV DNA level should be incorporated as the selection factor in future clinical trials of adjuvant therapy in NPC.

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Biomarker analysis of randomized controlled trial (RCT) of adjuvant chemotherapy (CT) using plasma EBV DNA to identify patients (pts) at higher risk of relapse after radiotherapy (RT) or chemoradiation (CRT) in nasopharyngeal cancer (NPC)

Annals of Oncology ◽

10.1093/annonc/mdx665 ◽

2017 ◽

Vol 28 ◽

pp. x100

Author(s):

E.P. Hui ◽

A.T.C. Chan ◽

R.K.C. Ngan ◽

S.Y. Tung ◽

A.C.K. Cheng ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Adjuvant Chemotherapy ◽

Controlled Trial ◽

Nasopharyngeal Cancer ◽

Randomized Controlled ◽

Biomarker Analysis ◽

Ebv Dna ◽

Risk Of Relapse

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Effects of a dietary intervention on gastrointestinal symptoms after prostate cancer radiotherapy: Long-term results from a randomized controlled trial

Radiotherapy and Oncology ◽

10.1016/j.radonc.2014.11.025 ◽

2014 ◽

Vol 113 (2) ◽

pp. 240-247 ◽

Cited By ~ 11

Author(s):

Anna Pettersson ◽

Peter Nygren ◽

Christina Persson ◽

Anders Berglund ◽

Ingela Turesson ◽

...

Keyword(s):

Prostate Cancer ◽

Randomized Controlled Trial ◽

Dietary Intervention ◽

Controlled Trial ◽

Gastrointestinal Symptoms ◽

Long Term Results ◽

Cancer Radiotherapy ◽

Randomized Controlled ◽

Prostate Cancer Radiotherapy

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Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

American Journal of Speech-Language Pathology ◽

10.1044/2019_ajslp-cac48-18-0227 ◽

2020 ◽

Vol 29 (1S) ◽

pp. 412-424

Author(s):

Elissa L. Conlon ◽

Emily J. Braun ◽

Edna M. Babbitt ◽

Leora R. Cherney

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Treatment Protocol ◽

Treatment Fidelity ◽

Protocol Adherence ◽

Study Condition ◽

Randomized Controlled ◽

Aphasia Therapy ◽

Percent Accuracy ◽

Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

Journal of Speech Language and Hearing Research ◽

10.1044/2019_jslhr-l-18-0257 ◽

2019 ◽

Vol 62 (12) ◽

pp. 4464-4482 ◽

Cited By ~ 9

Author(s):

Diane L. Kendall ◽

Megan Oelke Moldestad ◽

Wesley Allen ◽

Janaki Torrence ◽

Stephen E. Nadeau

Keyword(s):

Randomized Controlled Trial ◽

Response Latency ◽

Controlled Trial ◽

Semantic Knowledge ◽

Semantic Feature ◽

Feature Analysis ◽

Group Differences ◽

Randomized Controlled ◽

Confrontation Naming ◽

Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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