Rate of complete chemotherapy as planned with comprehensive geriatric assessment guided intervention among vulnerable elderly cancer patients: A randomized-open-label study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24021-e24021
Author(s):  
Manupol Maikami ◽  
Napa Parinyanitikul ◽  
Nattaya Poovorawan
Keyword(s):  
Usual Care ◽  
Cancer Patients ◽  
Comprehensive Geriatric Assessment ◽  
Intervention Group ◽  
Control Group ◽  
Open Label ◽  
Elderly Cancer Patients ◽  
Open Label Study ◽  
Label Study ◽  
Significant Difference

e24021 Background: The Geriatric 8 (G8) is a simplified screening tool to select the appropriate elderly patients for chemotherapy. Vulnerable patients with impaired G8 score might need additional comprehensive geriatric assessment (CGA) with intervention for individual problem. However, the impact of CGA and therapeutic intervention on rate of complete chemotherapy among these patients is rarely addressed. This study aims to evaluate the benefit of CGA guided intervention. Methods: A single center, randomized, open-label study which included newly diagnosed elderly cancer patients (age ≥ 65) with impaired G8 score (≤ 14) who were designated for chemotherapy. After the enrollment, patients were randomized to 1:1 ratio to receive CGA guided intervention (intervention group) or usual care (control group). The primary end point was the rate of complete chemotherapy at 90-day. Associated factors for complete chemotherapy were evaluated. Results: Between June 2019 and December 2019, 52 patients were randomized (26 patients for intervention group and 26 patients for control group). Mean age was 72 years, 59.6% was female, 40.4% had breast cancer and 51.9% had early stage cancer. With G8 assessment, 55.8% had intermediate (score 11-14) and 44.2% had low (score < 11) impaired G8 score. All baseline characteristics were balanced. Using per protocol analysis, there was no significant difference in rate of complete chemotherapy between groups (61.9% vs 50%, OR 1.63; 95%Cl 0.51-5.23; p = 0.42). Considering subgroup analysis in the intermediate G8 score patients, the intervention group had a significant higher rate of complete chemotherapy than control group (81.8% vs 66.7%, OR 2.71; p = 0.02), but no significant difference in low G8 score group (40% vs 27.3%, OR 1.78; p = 0.58). In univariate analysis, age below 75 years, BMI > 20 kg/m2 and intermediate G8 score showed significant factors for improving rate of complete chemotherapy. Conclusions: This is the first study in south-east Asia using CGA and intervention to improve rate of completion in chemotherapy. Although the CGA and intervention had no significant difference but had tendency to be better in completion rate of chemotherapy than usual care. The intermediate-impaired G8 score subgroup is more likely to benefit from CGA guided intervention for complete chemotherapy as planned.

Effect of personalized wrist orthosis for wrist pain with three-dimensional scanning and printing technique: A preliminary, randomized, controlled, open-label study

2018 ◽  
Vol 42 (6) ◽  
pp. 636-643 ◽  
Author(s):  
Sang Jun Kim ◽  
Sung Jae Kim ◽  
Yong Ho Cha ◽  
Keun Ho Lee ◽  
Jeong-Yi Kwon
Keyword(s):  
Hand Function ◽  
Three Dimensional ◽  
Wrist Pain ◽  
Control Group ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
High Satisfaction ◽  
Significant Difference ◽  
Experimental Group

Background: Three-dimensional printer technology can produce the personalized orthosis in various forms. Objective: To develop a personalized wrist orthosis using a three-dimensional scanner and three-dimensional printer for patients with wrist pain. Study design: A preliminary, prospective, randomized, open-label study. Methods: A total of 22 patients with wrist pain were randomly assigned to the control and experimental groups. The control group wore a cock-up orthosis and the experimental group wore a three-dimensional-printed wrist orthosis for 1 week. The Patient-Rated Wrist Evaluation, Jebsen Hand Function Test, and Orthotics and Prosthetics Users’ Survey were checked before and 1 week after the application. Results: The Patient-Rated Wrist Evaluation showed significant pain relief in both groups. Two items of the 28 Orthotics and Prosthetics Users’ Survey questions, “Put toothpaste on brush and brush teeth” and “Dial a touch tone phone,” showed high satisfaction scores, with statistically significant difference in the experimental group ( p = 0.036 and 0.004). Conclusion: The three-dimensional-printed wrist orthosis was superior to the cock-up orthosis for two items of the Orthotics and Prosthetics Users’ Survey. Wrist pain was reduced in the group wearing the three-dimensional-printed wrist orthosis as well as the group wearing the cock-up orthosis, so the three-dimensional-printed wrist orthosis could possibly play the same role as the cock-up orthosis. Clinical relevance A three-dimensional-printed wrist orthosis can be a substitute for a conventional ready-made wrist orthosis for patients with wrist pain with more satisfaction.

A phase I, open-label study of the safety, tolerability and pharmacokinetics of lapatinib (GW572016) in combination with letrozole in cancer patients

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 3001-3001 ◽  
Author(s):  
Q. Chu ◽  
L. Goldstein ◽  
N. Murray ◽  
E. Rowinsky ◽  
M. Cianfrocca ◽  
...  
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

An open-label study to evaluate dose and cycle dependence of the pharmacokinetics (PK) of pegylated liposomal doxorubicin (PLD)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 2012-2012 ◽  
Author(s):  
A. Gabizon ◽  
R. Isacson ◽  
O. Rosengarten ◽  
D. Tzemach ◽  
H. Shmeeda ◽  
...  
Keyword(s):  
Dose Range ◽  
Pegylated Liposomal Doxorubicin ◽  
Skin Toxicity ◽  
Significant Inhibition ◽  
Open Label ◽  
Cycle Number ◽  
Open Label Study ◽  
Label Study ◽  
Mean Values ◽  
Significant Difference

2012 Background: There are no definitive data in humans on the dose dependency and/or cycle dependency of the pharmacokinetics of PLD. The skin toxicity of PLD tends to worsen after several treatment cycles. Therefore, it is important to characterize the PK of PLD after 2 or more cycles. Methods: Fifteen patients with various solid tumors were randomized to two arms of treatment in an open-label study. Arm A received PLD at doses of 60, 30, and 45 mg/m2 in 3 successive cycles every 4 weeks (q4w). Arm B received PLD at doses of 30, 60, and 45 mg/m2 in 3 successive cycles q4w. Twelve patients, 6 on each arm, completed all three cycles and were fully evaluable. Plasma levels of doxorubicin were analyzed by HPLC and fluorimetry following a previously published method (J Chromatogr B, 779:259–69, 2002) with minor modifications. PK analysis was done by non-compartmental method. The following parameters were obtained: Cmax, AUC∞, terminal half-life (T1/2), and Clearance (CL). The paired t test was used for statistical analysis. Results: There was no significant difference in the parameters examined when the dose was increased from 30 to 60 mg/m2. However, when we analyzed the effect of cycle number on the PK, we found a gradual and significant inhibition of CL when patients advance from the 1st through the 3rd cycle of PLD (p=0.0003), with a mean increase of 44% in AUC/mg dose (p=0.0011). Cmax and T1/2 mean values increased by 17% and 18% respectively between the 1st and 3rd cycles, but only the increase in T1/2 was statistically significant (p=0.0127). Conclusion: While the PK of PLD is not dose-dependent within the dose range of 30 to 60mg/m2, there is evidence of a cycle-dependent effect that results in inhibition of CL when patients receive successive cycles of PLD. This effect may account for the delayed skin toxicity of PLD. These results suggest the need for dose adjustments of PLD to minimize the risk of toxicity, such as an initial high loading dose followed by reduced maintenance doses from the 2nd or 3rd cycle onwards. [Table: see text] [Table: see text]

Tapentadol in neuropathic pain cancer patients: a prospective open label study

2017 ◽  
Vol 38 (10) ◽  
pp. 1747-1752 ◽  
Author(s):  
Edvina Galiè ◽  
Veronica Villani ◽  
Irene Terrenato ◽  
Andrea Pace
Keyword(s):  
Neuropathic Pain ◽  
Cancer Patients ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Low-dose levomepromazine in refractory emesis in advanced cancer patients: an open-label study

2005 ◽  
Vol 19 (1) ◽  
pp. 71-75 ◽  
Author(s):  
Jorge H Eisenchlas ◽  
Nicolás Garrigue ◽  
Marta Junin ◽  
Gustavo G De Simone
Keyword(s):  
Cancer Patients ◽  
Advanced Cancer ◽  
Low Dose ◽  
Advanced Cancer Patients ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Refractory Emesis

scholarly journals A study of effect of topical anaesthetics on injection pain during immunization in infants

2020 ◽  
Vol 7 (7) ◽  
pp. 1463
Author(s):  
Magesh Kumar ◽  
V. Venkateshwar
Keyword(s):  
Intervention Group ◽  
Injection Pain ◽  
Control Group ◽  
P Value ◽  
Open Label ◽  
Topical Anesthetic ◽  
Vaccine Injection ◽  
Pain Scores ◽  
Significant Difference ◽  
Group B

Background: Immunization is a necessary aspect of health care of children and injections are there for unavoidable. Many factors affect injection pain during immunization in infants. This study aims to see the effect of use of local anesthetics delivered by various modes for attenuation of vaccine related injection pain in infants and to compare them.Methods: An Open Label Four-Arm Randomized Control Trial of 300 healthy infants of age group 6 weeks to 6 months reported to immunization clinic for immunization with DPT-HiB-Hepatitis B combination vaccine were taken for study. The enrolled subjects were allocated into control group and intervention group (who were applied some form of local anesthesia).Results: Among the four groups of the patients studied we observed a statistical difference in the mean pain scores of the patients recorded at 15 second, 60 second and 5 min after vaccine injection (p value 0.0024 - 0.000). Group A (Infants with topical occlusive LA cream) showed minimum pain scores values at 15 second, 60 second and 5 min after vaccine injection, followed by Group C (Infants with topical LA spray with vapocoolant) whereas Control group (Infants not received any local anaesthesia) and Group B (Infants with topical LA spray without vapocoolant) exhibited the maximum pain scores.Conclusions: Topical occlusive local anesthetic cream and topical LA spray with vapocoolent, were found to be better than topical LA spray without vapocoolant or no topical anesthetic. Use of topical occlusive LA cream led to a lowest pain score. There was no significant difference in the profile of side effects following injection in the four group.

scholarly journals A randomised controlled trial to evaluate a medication monitoring system for TB treatment

2022 ◽  
Vol 26 (1) ◽  
pp. 44-49
Author(s):  
J. Acosta ◽  
P. Flores ◽  
M. Alarcón ◽  
M. Grande-Ortiz ◽  
L. Moreno-Exebio ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Treatment Success ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Second Phase ◽  
Open Label ◽  
Pulmonary Tb ◽  
Tb Treatment ◽  
Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

scholarly journals EFEKTIVITAS LATIHAN PERNAFASAN RELAKSASI TERHADAP KELELAHAN PADA PASIEN KANKER YANG MENJALANI KEMOTERAPI

2020 ◽  
Vol 8 (01) ◽  
pp. 144-158
Author(s):  
Vervando Janter Sumilat ◽  
Prabawati Prabawati ◽  
Sudibyo Supardi
Keyword(s):  
Cancer Patients ◽  
Intervention Group ◽  
Sampling Technique ◽  
Wilcoxon Test ◽  
Control Group ◽  
P Value ◽  
Breathing Exercise ◽  
Chemotherapy Drugs ◽  
Breathing Exercises ◽  
Significant Difference

Abstract Background: Cancer patients with chemotherapy experience fatigue as cancer effects and cell destruction due to the toxicity of chemotherapy drugs. Objective: Determine the effectiveness of relaxation breathing exercises to fatigue cancer patients who undergoing chemotherapy. Methode: This research used quasi experiment pretest and posttest method. There were 92 respondents who examined using purposive sampling technique and divided into 46 respondents as intervention group and 46 respondents as control group. Relaxation breathing exercise was given four weeks for intervention group on April-July 2018 in Siloam Hospital Manado. Result: The majority of cancer patients were age 45-65 years 69,9%, 54,3% were diagnosed cancer ≤1 year and 79,3% received combination chemotherapy. The result of Wilcoxon test revealed there was significant difference before and after intervention to fatigue (p value = 0,00), with mean rank of reduction 21,97% on fatigue. The result of Mann Whitney test revealed that there was significant difference in fatigue between intervention and control groups (p value = 0,00). Multivariate logistic regression revealed that there was an effect of relaxation breathing exercise on fatigue (p value = 0,00) and relaxation breathing exercise may reduce 60,46 times of fatigue on patients who undergoing chemotherapy. Conclusion: Relaxation Breathing Exercise can reduce fatigue in cancer patients who undergoing chemotherapy in Siloam Hospital Manado. It is recommended to perform relaxation breathing exercise as a routine exercise for cancer patients during chemotherapy to minimize fatigue. Keywords: Relaxation Breathing Exercise, Fatigue, Chemotherapy, Cancer

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