03 - EFFECTIVENESS OF A TAILORED MOISTURIZER ON CHEMOTHERAPY-INDUCED SKIN DRYNESS AMONG BREAST CANCER PATIENTS : DOUBLE-BLIND CONTROLLED CLINICAL TRIAL

Abstract Purpose To evaluate the effectiveness of photobiomodulation (PBMT) in preventing dysgeusia in breast cancer patients treated with doxorubicin-cyclophosphamide (AC). Methods This is a phase II, randomized, triple-blind, placebo-controlled clinical trial involving 112 breast cancer patients treated with AC. The patients were divided equally into two groups: a test group treated with 2 J red laser and 3 J infrared laser on 21 points that were symmetrically distributed on the tongue on day 0 of four cycles of AC, and an equal placebo group treated with simulated PBMT to blind the patient, evaluator, and statistician. The clinicopathological and sociodemographic data, results of the hematological tests, taste test, and subjective taste analysis, and the QoL, ECOG performance status, body mass index, and other side effects were recorded. The data were analyzed using ANOVA-RM/Bonferroni, Friedman/Dunn, and chi-square/Fisher's exact tests. Results PBMT patients showed less objective and subjective taste loss (p < 0.05). On the other hand, the placebo group showed a higher ECOG status (p = 0.037) and more significant weight loss (p < 0.001) after four cycles of AC. The QoL was significantly higherin the PBMT group (p < 0.05) at all assessment periods, and PBMT treatment also reduced the incidence of cachexia (p = 0.020), anorexia (p < 0.001), diarrhea (p = 0.040), oral mucositis (p = 0.020), and vomiting (p = 0.008). Conclusion PBMT reduced the taste loss and improved the overall health status and QoL of patients with breast cancer treated with AC. Trial registration : Brazilian Clinical Trials Registry (www.ensaiosclinicos.gov.br) approval numberRBR-9qnm34y, registered on 01/05/2021

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

The Breast Journal ◽

10.1111/tbj.13979 ◽

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

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Effects of a self-management program on antiemetic-induced constipation during chemotherapy among breast cancer patients: a randomized controlled clinical trial

Breast Cancer Research and Treatment ◽

10.1007/s10549-015-3652-4 ◽

2015 ◽

Vol 155 (1) ◽

pp. 99-107 ◽

Cited By ~ 8

Author(s):

Akiko Hanai ◽

Hiroshi Ishiguro ◽

Takashi Sozu ◽

Moe Tsuda ◽

Hidenori Arai ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Cancer Patients ◽

Management Program ◽

Self Management ◽

Controlled Clinical Trial ◽

Breast Cancer Patients ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled

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

Trials ◽

10.1186/s13063-021-05800-w ◽

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.

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