scholarly journals Comparison of the Effect of Alpha and Hydrocortisone Ointments on Prevention of Acute Skin Complications Due to Radiotherapy in Breast Cancer Patients

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Mansour Rezaei ◽  
Ahmad Khoshay ◽  
Nasrin Amirifard ◽  
Ali Goli ◽  
Alireza Abdi
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Informed Consent ◽  
Side Effects ◽  
Cancer Patients ◽  
Breast Cancer Patients ◽  
The Third ◽  
Patient Complaints

Background. Radiotherapy in breast cancer patients is associated with acute and delayed side effects. This study aimed to compare the effect of alpha and hydrocortisone 1% (H1%) ointments on prevention of acute skin complications due to radiotherapy in breast cancer patients. Methods. This clinical trial was conducted on 86 patients with breast cancer in the radiotherapy center of Imam Reza Hospital of Kermanshah, Iran. Using the records, the patients were selected and randomly divided into alpha and H1% groups after obtaining informed consent. The severity of dermatitis, complications, and patient complaints during treatment were evaluated weekly for up to 6 weeks by RTOG criteria. Data were analyzed using SPSS-16 software. Results. At the end of the third, fourth, fifth, and sixth weeks, 10 (11.7%), 25 (29.1%), 53 (61.6%), and 28 (32.6%) patients had skin complications, respectively. In weeks 5 and 6 in the H1 group, the incidence of complications was higher ( P  = 0.001). The frequency of pain and burning complaints at the end of the third, fourth, fifth, and sixth weeks was 15 (17.4%), 37 (43.0%), 52 (60.5%), and 1(1.2%), respectively. Pain and burning intensity in the fourth and fifth weeks in the H1 group was lower than alpha ( P  = 0010). Complaints of skin itching at the end of the third, fourth, and fifth weeks were 16 (18.6%), 25 (29.1%), and 28 (32.6), respectively. This complication was lower in the H1% group during these weeks ( P  < 0.05). Conclusion. Alpha ointment is more effective than H1% in relieving pain and burning, preventing complications except itching. It seems using an alpha ointment or combining it with H1% is an appropriate strategy to reduce the rate of injuries and skin complications of radiotherapy.

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 Comparing the Efficacy and Side Effects of PDLASTA® (Peg-Filgrastim) with PDGRASTIM® (Filgrastim) in Breast Cancer Patients; A Non-inferiority Randomized Clinical Trial

2020 ◽  
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 to evaluate the efficacy and safety of a single dose (Peg-Filgrastim 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 recruited and allocated randomly in two equal arms. In one group, a single subcutaneous dose of 6 mg of PDL was injected the day after receiving a chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of 300 micrograms per day for six consecutive days in each course of treatment. Side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight courses of chemotherapy.Results: hematologic parameters showed no significant difference in each course of treatment between two groups of study. The comparison of the 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 eight courses of treatment identified no statistically significant difference between two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs.Conclusion: Regarding our results, PDL is completely non- inferior in efficacy and also less toxic compared to PDG. Prescribing in single-dose and lower expenses of PDL introduces it as a cost-effective drug in the treatment of chemotherapy-induced neutropenia. Trial registration number, date of registration: IRCT20190504043465N1, May 2019https://www.irct.ir/search/result?query=IRCT20190504043465N1

scholarly journals The impact of hyperbaric oxygen therapy on late radiation toxicity and quality of life in breast cancer patients

2021 ◽  
Author(s):  
Marilot C. T. Batenburg ◽  
Wies Maarse ◽  
Femke van der Leij ◽  
Inge O. Baas ◽  
Onno Boonstra ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Side Effects ◽  
Cancer Patients ◽  
Oxygen Therapy ◽  
Radiation Toxicity ◽  
Breast Pain ◽  
Breast Cancer Patients

Abstract Purpose To evaluate symptoms of late radiation toxicity, side effects, and quality of life in breast cancer patients treated with hyperbaric oxygen therapy (HBOT). Methods For this cohort study breast cancer patients treated with HBOT in 5 Dutch facilities were eligible for inclusion. Breast cancer patients with late radiation toxicity treated with ≥ 20 HBOT sessions from 2015 to 2019 were included. Breast and arm symptoms, pain, and quality of life were assessed by means of the EORTC QLQ-C30 and -BR23 before, immediately after, and 3 months after HBOT on a scale of 0–100. Determinants associated with persistent breast pain after HBOT were assessed. Results 1005/1280 patients were included for analysis. Pain scores decreased significantly from 43.4 before HBOT to 29.7 after 3 months (p < 0.001). Breast symptoms decreased significantly from 44.6 at baseline to 28.9 at 3 months follow-up (p < 0.001) and arm symptoms decreased significantly from 38.2 at baseline to 27.4 at 3 months follow-up (p < 0.001). All quality of life domains improved at the end of HBOT and after 3 months follow-up in comparison to baseline scores. Most prevalent side effects of HBOT were myopia (any grade, n = 576, 57.3%) and mild barotrauma (n = 179, 17.8%). Moderate/severe side effects were reported in 3.2% (n = 32) of the patients. Active smoking during HBOT and shorter time (i.e., median 17.5 vs. 22.0 months) since radiotherapy were associated with persistent breast pain after HBOT. Conclusion Breast cancer patients with late radiation toxicity reported reduced pain, breast and arm symptoms, and improved quality of life following treatment with HBOT.

Time to Progression in Metastatic Breast Cancer Patients Treated With Epirubicin Is Not Improved by the Addition of Either Cisplatin or Lonidamine: Final Results of a Phase III Study With a Factorial Design

2002 ◽  
Vol 20 (20) ◽  
pp. 4150-4159 ◽  
Author(s):  
Alfredo Berruti ◽  
Raffaella Bitossi ◽  
Gabriella Gorzegno ◽  
Alberto Bottini ◽  
Palmiro Alquati ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Side Effects ◽  
Factorial Design ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Time To Progression ◽  
Phase Iii Study

PURPOSE: To investigate the value of the addition of either cisplatin (CDDP) or lonidamine (LND) to epirubicin (EPI) in the first-line treatment of advanced breast cancer. PATIENTS AND METHODS: Three hundred seventy-one metastatic breast cancer patients with no prior systemic chemotherapy for advanced disease were randomized to receive either EPI alone (60 mg/m2 on days 1 and 2 every 21 days), EPI and CDDP (30 mg/m2 on days 1 and 2 every 21 days), EPI and LND (450 mg orally daily, given continuously), or EPI, CDDP, and LND. Time to progression, response rates, side effects, and survival were compared according to the 2 × 2 factorial design of this study. RESULTS: The groups were well balanced with respect to prognostic factors. Time to progression did not differ in the comparison between CDDP arms and non-CDDP arms (median, 10.9 months v 9.4 months, respectively; P = .10) or between that of LND arms and non-LND arms (median, 10.8 months v 9.9 months, respectively; P = .47), nor did overall survival. The response rate did not significantly differ in the comparison between LND arms and non-LND arms (62.9% v 54.0%, P = .08). No difference in treatment activity was observed between CDDP arms and non-CDDP arms. Toxicity was significantly higher in the CDDP arms, leading to CDDP dose adjustment in 40% of cases. The most frequent side effects were of a hematologic and gastrointestinal nature. The addition of LND produced more myalgias and fatigue. CONCLUSION: Neither CDDP nor LND was able to significantly improve the time to progression obtained by EPI. CDDP, however, significantly worsened the drug’s tolerability.

Reduction of Chemotherapy–Induced Side Effects by Complementary Medicine in Breast Cancer Patients

2021 ◽  
Vol 8 (2) ◽  
Author(s):  
Beuth J ◽  
◽  
Böwe R ◽  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Complementary Medicine ◽  
Sodium Selenite ◽  
Lens Culinaris ◽  
Proteolytic Enzymes ◽  
Clinical Investigation ◽  
Breast Cancer Patients ◽  
Complementary Treatment

This clinical investigation was performed to evaluate the benefit of Complementary Medicine (CM) in breast cancer patients undergoing adjuvant Chemotherapy (ChT). Patients and Methods: The patients (n=668) were treated according to international guidelines with adjuvant ChT. As to reduce the side effects, the patients were complementarily treated with a combination of sodium selenite, proteolytic plant enzymes (bromelaine and papain) and Lens culinaris lectin. On Case Report Formulas (CRFs) assessment of side effects of ChT was documented at defined times during adjuvant ChT and additional complementary treatment. Validation was carried out by scoring from 1 (no side-effects/optimal tolerability) to 6 (extreme side-effects/extremely bad tolerability), however, only patients suffering from severe side effects (symptom scores 4 and higher) were enrolled into this investigation. Results: The severity of side-effects of ChT was significantly reduced by complementary treatment. Mean scores of symptoms declined for sleep disorder, fatigue, lack of drive (p<0.05) and for arthralgia, hot flushes, mucosal dryness, nausea, vomiting, diarrhea, loss of appetite, pain of tumour (p<0.001). Conclusion: This investigation confirms benefits of indication-based complementary treatment with the combination of sodium selenite, proteolytic enzymes and Lens culinaris lectin in breast cancer patients, e.g. reduction of side-effects of adjuvant ChT.

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