scholarly journals Lithium and preventing chemotherapy-induced peripheral neuropathy in breast cancer patients: a placebo-controlled randomized clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
S. Najafi ◽  
Z. Heidarali ◽  
M. Rajabi ◽  
Z. Omidi ◽  
F. Zayeri ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Peripheral Neuropathy ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Common Adverse Effect ◽  
Signs And Symptoms ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Study Results

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of some chemotherapy regimens. Lithium has been suggested for CIPN in some animal studies. We aimed to study lithium’s preventive effect on CIPN in breast cancer patients treated with taxanes and platinum-based medications. Method A double-blind placebo-controlled randomized clinical trial (RCT) was implemented on 36 breast cancer patients in two equal-size groups by block randomization. Participants in both groups consumed daily tablets, either placebo or lithium (300 mg), for 5 days in each course of chemotherapy. The tablets were prescribed 1 day before the start of chemotherapy. The electromyography (EMG) and nerve-conduction-velocity (NCV) tests were achieved before the first chemotherapy, 3 and 9 months after the treatment. The changes and signs or symptoms of CIPN, such as numbness, tingling, freezing, sensitivity to touch, muscle weakness, fibrillation, and knee and elbow reflex disorders, were recorded by examination. The trend of outcome changes was compared between two groups during the 9 months of study. Results In both groups, neurologic signs and symptoms were exacerbated during the first 3 months and improved up to the ninth month of study. Results showed significant changes of all EMG-NCV variables during the 9 months of research in each group (P < 0.001), but the interaction of time and group effect was not significant in none of those indices. All symptoms changed significantly over the study time (P < 0.001) without significant statistical difference between the two groups (P=0.352). No side effect was found during the study. Conclusion The study showed that 300 mg lithium prescription once daily for 5 days might not effectively prevent CIPN in breast cancer patients. Evaluation of lithium effect on CIPN on different cancers in future studies is suggested. Trial registration Iranian Registry of Clinical Trials IRCT20160813029327N10.  Registration date: May 16, 2018.

Study of pregabalin effect on postsurgical pain in breast cancer patients: A double‐blind randomized clinical trial using placebo

2020 ◽  
Vol 26 (11) ◽  
pp. 2286-2288
Author(s):  
Ali Mir ◽  
Niayesh Mohebbi ◽  
Ramesh Omranipour ◽  
Mojtaba Sedaghat ◽  
Marzieh Lashkari ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Postsurgical Pain

scholarly journals Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Safa Najafi ◽  
Maryam Ansari ◽  
Vahid Kaveh ◽  
Shahpar Haghighat
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Single Dose ◽  
Side Effects ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Injection Site Reaction ◽  
Study Groups ◽  
Breast Cancer Patients ◽  
Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

scholarly journals Curcumin for Radiation Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Thirty Breast Cancer Patients

2013 ◽  
Vol 180 (1) ◽  
pp. 34-43 ◽  
Author(s):  
Julie L. Ryan ◽  
Charles E. Heckler ◽  
Marilyn Ling ◽  
Alan Katz ◽  
Jacqueline P. Williams ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Cancer Patients ◽  
Radiation Dermatitis ◽  
Controlled Clinical Trial ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals Citalopram and group psychotherapy in breast cancer patients: A randomized clinical trial

2018 ◽  
Vol 32 (1) ◽  
pp. 394-399
Author(s):  
Novin Nikbakhsh ◽  
Sussan Moudi ◽  
Sara Alvarzandi ◽  
Maede Niazifar ◽  
Nazila Farnoush ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Group Psychotherapy ◽  
Breast Cancer Patients

scholarly journals Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial

2020 ◽  
Vol 19 ◽  
pp. 153473542093843
Author(s):  
Talita Uchoa Lima ◽  
Ed Carlos Rey Moura ◽  
Caio Márcio Barros de Oliveira ◽  
Rachel Jorge Dino Cossetti Leal ◽  
João Nogueira Neto ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Adverse Events ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
Music Intervention ◽  
Subjective Impression

Background: Music can influence human behavior and may be used as a complementary therapy in health care. Objectives: To assess the effect of music interventions on symptoms, adverse events, and quality of life (QoL) of breast cancer patients undergoing chemotherapy (CT). Design: Nonblinded, randomized clinical trial. Women with breast cancer undergoing adjuvant CT were randomized into 2 groups—Group Music (GM) or Group Control (GC)—and followed during the first 3 cycles of treatment. Measurements: Sociodemographic data, WHOQOL-BREF, BDI-II, BAI, and Chemotherapy Toxicity Scale were assessed. Patients were evaluated after each session of the first 3 CT cycles. GM underwent a 30-minute musical intervention before CT. There was no intervention in the GC. Continuous data were analyzed by Student’s t test, and χ2 test was used to compare qualitative variables. Results: Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT. Depression ( P < .001) and anxiety scores ( P < .001) and vomiting ( P < .01) incidence were lower for the GM in the third session of CT. All the participants in the GM reported positive changes in life in the Subjective Impression of the Subject questionnaire, as well as improvement in fatigue and reduced stress levels. Conclusions: Improvements in QoL, anxiety, depression, and incidence of vomiting were associated with the music intervention, suggesting a positive effect of the music intervention on adverse events of cancer CT.

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