scholarly journals Acute pain and side effects after tramadol in breast cancer patients: results of a prospective double-blind randomized study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Nikola Besic ◽  
Jaka Smrekar ◽  
Branka Strazisar
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Acute Pain ◽  
Randomized Study ◽  
Double Blind Study ◽  
Breast Cancer Patients ◽  
Dose Frequency ◽  
Double Blind ◽  
Axillary Lymphadenectomy

Abstract The objective of this study was to evaluate the severity of acute pain and side effects in breast cancer patients postoperatively treated with two regimens of tramadol with paracetamol in a prospective double-blind study. Altogether 117 breast cancer patients who had axillary lymphadenectomy were randomized into two analgesic study groups and the analgesic treatment lasted 4 weeks. Stronger analgesia group received every 8 h 75/650 mg of tramadol with paracetamol, while weaker analgesia group received every 8 h 37.5/325 mg of tramadol with paracetamol. Patients with the higher dose of tramadol had less pain during the 1st and 4th week than patients with the lower dose. Frequency of nausea, vomiting, lymphedema or range of shoulder movement was not significantly different between the two groups of patients. Constipation was significantly more common in the group with stronger analgesia during the 2nd week in comparison to patients with weaker analgesia. The patients who were on 75/650 mg of tramadol with paracetamol had less pain in comparison to patients who were on 37.5/325 mg. Side effects were mild, but common in both groups of patients.

scholarly journals EFFICACY AND SAFETY OF STANDARDIZED CINNAMON BARK EXTRACT FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED WEIGHT LOSS AND ALOPECIA IN PATIENTS WITH BREAST CANCER: A RANDOMIZED, DOUBLE-BLIND, AND PLACEBO-CONTROLLED STUDY

2019 ◽  
pp. 163-168
Author(s):  
AJAY MEHTA ◽  
SUCHITRA MEHTA ◽  
PRASAD THAKURDESAI
Keyword(s):  
Breast Cancer ◽  
Weight Loss ◽  
Side Effects ◽  
Cancer Patients ◽  
Outcome Measures ◽  
Bark Extract ◽  
Efficacy And Safety ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Cinnamon Bark

Objective: The objective of the study was to evaluate the effects of IND02 (standardized Cinnamon bark extract) supplementation for the prevention of side effects of cancer chemotherapy in female patients with breast cancer. Methods: The study was conducted using double-blind, placebo-controlled design in 34 female breast cancer patients during the first 4 consecutive 21-day cycles of the standard chemotherapy regimen. The active treatment (IND02 capsules, 400 mg, one capsule, and thrice a day) or matching placebo was orally administrated in randomized (1:1 ratio) patients. The efficacy outcome measures were reduction in chemotherapy-induced weight loss, alopecia (hair fall), and other side effects. The safety outcome measures were hematology, ECG, vital signs, adverse event monitoring, and laboratory safety measurements. Results: The patients on the treatment with IND02 had shown significant protection from chemotherapy-induced severe weight loss (cachexia) and alopecia (reduced hair density and % hairs in the anagen phase, and increased % hairs in telogen phase) which was seen in the placebo group. IND02 treatment was found safe and well-tolerated during the study. Conclusion: Concomitant use of IND02 in breast cancer patients during breast cancer chemotherapy showed a clinical promise regarding efficacy and safety in preventing chemotherapy-induced weight loss and alopecia.

A double-blind, randomized cross-over trial of venlafaxine versus clonidine to treat hot flashes in breast cancer patients

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9083-9083
Author(s):  
C. Mom ◽  
C. Buijs ◽  
P. H. Willemse ◽  
H. Boezen ◽  
J. Maurer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Cancer Patients ◽  
Hot Flashes ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Hot Flash ◽  
History Of ◽  
Loss Of Appetite ◽  
To Receive

9083 Background: Breast cancer patients who become postmenopausal due to their treatment can experience more frequent and severe hot flashes than healthy postmenopausal women. Estrogens are considered to be contra-indicated. Venlafaxine and clonidine are both used to alleviate hot flashes, with different side effects. This study compared side effects, efficacy and patient preference. Methods: In a double-blind, cross-over study women <60 years, with a history of breast cancer, and experiencing at least 14 hot flashes/week were randomized to receive venlafaxine 75 mg od (and placebo bid) for 8 weeks, followed by a 2 week wash-out period, and 8 weeks of clonidine 0.025 mg bid (and placebo od) or vice versa. Hot flash frequency and hot flash score (frequency × severity) were recorded in a diary and side effects were scored using a questionnaire during the 2nd and 8th week of both treatment periods, and these were compared to a baseline week. Results: Sixty patients were randomized to start with venlafaxine (n=30) and clonidine (n=30), 40 completed both treatment periods. Premature treatment discontinuation occurred in 15/59 patients during venlafaxine and in 5/53 during clonidine due to side effects (p<0.05). The main side effects of venlafaxine were nausea and headache, and of clonidine dry mouth. In the 8th week of treatment women reported more loss of appetite (24% vs 4%; p=0.03) and improved sleeping (55% vs 75%; p=0.03) with venlafaxine. A =50% reduction in hot flash score was found in 21 (49%) and 26 (55%) of the patients with venlafaxine and clonidine respectively (ns). The decrease in hot flash score was most marked in the first treatment period. At study completion 20 (33%) of the patients chose to continue clonidine, and 17 (29%) preferred venlafaxine (ns), whereas 23 (38%) declined further treatment. Conclusions: Venlafaxine and clonidine are both moderately and equally effective in the reduction of hot flashes. Side effects are the main reason for discontinuation, occurring more often during treatment with venlafaxine. No significant financial relationships to disclose.

Chronic adverse effects after axillary lymphadenectomy in breast cancer patients after weaker and stronger postoperative analgesia: Results of a prospective double-blind randomized study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23066-e23066
Author(s):  
Nikola Besic ◽  
Jaka Smrekar ◽  
Branka Strazisar
Keyword(s):  
Breast Cancer ◽  
Chronic Pain ◽  
Neuropathic Pain ◽  
Adverse Effects ◽  
Cancer Patients ◽  
Postoperative Analgesia ◽  
Randomized Study ◽  
Breast Cancer Patients ◽  
Axillary Lymphadenectomy ◽  
One Year

e23066 Background: Tramadol is commonly used for pain treatment, but it is not known if stronger postoperative analgesia has an effect on chronic adverse effects in breast cancer patients. The aim of this study was to compare the rate of chronic adverse effects after weaker and stronger postoperative analgesia. Methods: A prospective double-blind randomized study included 118 breast cancer patients receiving tramadol for pain relief after axillary lymphadenectomy from 2015 to 2018 (Study EUDRA CT: 2015-000992-28). All patients used one of two analgesic regimens for 4 weeks after lymphadenectomy. Patients with larger dose received 75/650 mg of tramadol with paracetamol every 8 hours and a group with lower dose received 37.5/325 mg of tramadol with paracetamol every 8 hours. All patients received for four weeks twice daily naproxen sodium 550 mg and once a day pantoprazole 20 mg. One year after surgery patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema. The association between dose of tramadol and chronic postoperative adverse effects was evaluated using asymptotic z-test and chi-square test. Results: Neuropathic pain was more common one year in comparison to one month after lymphadenectomy (p = 0.0001). There was a trend for lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.058). Chronic pain was present in 18% of patients one year after lymphadenectomy. There was no difference in rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after stronger analgesia than after weaker analgesia (p = 0.02). Furthermore, there was a trend for lower rate of lymphedema of forearm after stronger analgesia than after lower analgesia (p = 0.078). Conclusions: The patients who received stronger postoperative analgesia had a statistical trend for less often neuropathic pain in comparison to patients who received weaker analgesia. The patients who received stronger postoperative analgesia had less arm symptoms and better quality of life in comparison to patients who received weaker analgesia. Clinical trial information: EudraCT 2015-000992-28.

Aprepitant (AP) versus dexamethasone (D) for preventing delayed emesis induced by anthracyclines plus cyclophosphamide (A+C) chemotherapy (CT) in breast cancer patients (pts): A double-blind, multicenter, randomized study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9614-9614 ◽  
Author(s):  
Fausto Roila ◽  
Enzo Ballatori ◽  
Alessandra Fabi ◽  
Sonia Fatigoni ◽  
Silvana Chiara ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Randomized Study ◽  
Complete Response ◽  
Similar Efficacy ◽  
Double Blind Study ◽  
Delayed Emesis ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Acute Emesis ◽  
Antiemetic Prophylaxis

9614 Background: A combination of AP + a 5-HT3 receptor antagonist + D and AP alone is recommended, respectively, for the prophylaxis of acute and delayed emesis induced by A+C CT in breast cancer pts. In the registrative study the role of AP in delayed emesis was not defined because prophylaxis of acute emesis was different between the two arms, and the superiority of AP on delayed emesis could be the consequence of a dependent effect on the different results achieved in acute phase. Aim of this study was to compare the efficacy of AP versus D in preventing delayed emesis in pts receiving the same prophylaxis of acute emesis. Methods: A randomized double-blind study comparing AP versus D was completed in naive breast cancer pts treated with A+C. Before CT, all pts were treated with intravenous palonosetron 0.25 mg and D 8 mg, and oral AP 125 mg. On days 2 and 3 pts randomly received D 4 mg bid or AP 80 mg qd. Primary endpoint was rate of complete response (no vomiting, no rescue treatment) from days 2 - 5 after CT. Results: From September 2009 to July 2012, 580 pts were enrolled; 551 were fully evaluated, 273 in arm D and 278 in arm AP. Day 1 complete response rates were similar: 239/273 (87.6%) in D arm and 236/278 (84.9%) in AP arm. From day 2-5, complete response was the same with both antiemetic prophylaxes (79.5%), and all secondary endpoints (complete protection, total control, no vomiting, no nausea, score of FLIE) assumed similar values. During the delayed phase, incidence of insomnia (2.9% vs. 0.4%) and heartburn (8.1% vs. 3.6%) was significantly superior in D arm. Conclusions: In breast cancer pts submitted to A+C CT and receiving the same antiemetic prophylaxis for acute emesis, D and AP present similar efficacy and toxicity. Clinical trial information: NCT 00869973.

scholarly journals Venlafaxine is superior to clonidine as treatment of hot flashes in breast cancer patients—a double-blind, randomized study

2007 ◽  
Vol 18 (4) ◽  
pp. 689-693 ◽  
Author(s):  
S. Loibl ◽  
K. Schwedler ◽  
G. von Minckwitz ◽  
R. Strohmeier ◽  
K.M. Mehta ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Randomized Study ◽  
Hot Flashes ◽  
Breast Cancer Patients ◽  
Double Blind

scholarly journals Attention Dysregulation in Breast Cancer Patients Following a Complementary Alternative Treatment Routine: A Double-Blind Randomized Trial

2021 ◽  
Vol 20 ◽  
pp. 153473542110194
Author(s):  
Talya Dolev ◽  
Merav Ben-David ◽  
Ilanit Shahadi ◽  
Yaakov Freed ◽  
Salman Zubedat ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Breast Cancer Survivors ◽  
Treatment Plan ◽  
Randomized Study ◽  
Well Being ◽  
Complementary Alternative Medicine ◽  
Breast Cancer Patients ◽  
Unilateral Breast Cancer ◽  
Double Blind

Introduction: Breast cancer patients and survivors frequently report fatigue, emotional, and cognitive disturbances, which reduce performance at all levels of occupation and make life quality issues a considerable clinical concern. The aim of this study is to evaluate attention and emotion regulation across radiotherapy period and the possible effects of complementary alternative medicine (CAM). Methods: Fifty-seven patients with unilateral breast cancer underwent surgery and systemic chemotherapy before participating in this double-blind randomized study. Two thirds were given CAM (n = 38) while the rest received placebo (carrier only, n = 19). Patients’ attention and anxiety were physiologically tested at baseline, 2 and 4 weeks during the radiation period as well as 1-month after the end of radiation session. Results: Both groups showed similar levels of anxiety with no significant differences at baseline nor post-radiotherapy. Long-term significant recovery of attention performance was observed in the CAM patients, accompanied by a similar tendency in anxiety level, measured by the eye-blink probability. Conclusions: This study physiologically validates the attention impairment reported among breast cancer survivors; also, it depicted a beneficial late-effect of a routine CAM on attention dysregulation. The suggested non-invasive physiological measures can physiologically monitor patients’ psychological and cognitive well-being as well as evaluate the beneficial effect of CAM in breast cancer patients by assessing their coping ability to support the treatment plan. Thus, the results have potential clinical implications on patients’ and survivors’ quality of life. Trial Registration: NIH, NCT02890316. Registered July 2016, http://www.ClinicalTrials.gov

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