Reduction of Cancer-Related Fatigue With Dexamethasone: A Double-Blind, Randomized, Placebo-Controlled Trial in Patients With Advanced Cancer

2013 ◽  
Vol 31 (25) ◽  
pp. 3076-3082 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
J. Lynn Palmer ◽  
Marvin O. Delgado-Guay ◽  
Janet Bull ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Symptom Distress ◽  
Controlled Study ◽  
Total Quality ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Dexamethasone Group ◽  
Edmonton Symptom Assessment Scale

Purpose Cancer-related fatigue (CRF) is the most common symptom in patients with advanced cancer. The primary objective of this prospective, randomized, double-blind, placebo-controlled study was to compare the effect of dexamethasone and placebo on CRF. Patients and Methods Patients with advanced cancer with ≥ three CRF-related symptoms (ie, fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance) ≥ 4 of 10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible. Patients were randomly assigned to either dexamethasone 4 mg or placebo orally twice per day for 14 days. The primary end point was change in the Functional Assessment of Chronic Illness–Fatigue (FACIT-F) subscale from baseline to day 15. Secondary outcomes included anorexia, anxiety, depression, and symptom distress scores. Results A total of 84 patients were evaluable (dexamethasone, 43; placebo, 41). Mean (± standard deviation) improvement in the FACIT-F subscale at day 15 was significantly higher in the dexamethasone than in the placebo group (9 [± 10.3] v 3.1 [± 9.59]; P = .008). The improvement in FACIT-F total quality-of-life scores was also significantly better for the dexamethasone group at day 15 (P = .03). The mean differences in the ESAS physical distress scores at day 15 were significantly better for the dexamethasone group (P = .013, respectively). No differences were observed for ESAS overall symptom distress (P = .22) or psychological distress score (P = .76). Frequency of adverse effects was not significantly different between groups (41 of 62 v 44 of 58; P = .14). Conclusion Dexamethasone is more effective than placebo in improving CRF and quality of life in patients with advanced cancer.

scholarly journals Effects of Melatonin on Appetite and Other Symptoms in Patients With Advanced Cancer and Cachexia: A Double-Blind Placebo-Controlled Trial

2013 ◽  
Vol 31 (10) ◽  
pp. 1271-1276 ◽  
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Null Hypothesis ◽  
Controlled Trial ◽  
Double Blind ◽  
Patients With Cancer ◽  
Edmonton Symptom Assessment Scale

Purpose Prior studies have suggested that melatonin, a frequently used integrative medicine, can attenuate weight loss, anorexia, and fatigue in patients with cancer. These studies were limited by a lack of blinding and absence of placebo controls. The primary purpose of this study was to compare melatonin with placebo for appetite improvement in patients with cancer cachexia. Patients and Methods We performed a randomized, double-blind, 28-day trial of melatonin 20 mg versus placebo in patients with advanced lung or GI cancer, appetite scores ≥ 4 on a 0 to 10 scale (10 = worst appetite), and history of weight loss ≥ 5%. Assessments included weight, symptoms by the Edmonton Symptom Assessment Scale, and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire. Differences between groups from baseline to day 28 were analyzed using one-sided, two-sample t tests or Wilcoxon two-sample tests. Interim analysis halfway through the trial had a Lan-DeMets monitoring boundary with an O'Brien-Fleming stopping rule. Decision boundaries were to accept the null hypothesis of futility if the test statistic z < 0.39 (P ≥ .348) and reject the null hypothesis if z > 2.54 (P ≤ .0056). Results After interim analysis of 48 patients, the study was closed for futility. There were no significant differences between groups for appetite (P = .78) or other symptoms, weight (P = .17), FAACT score (P = .95), toxicity, or survival from baseline to day 28. Conclusion In cachectic patients with advanced cancer, oral melatonin 20 mg at night did not improve appetite, weight, or quality of life compared with placebo.

Dexamethasone (DM) for cancer-related fatigue: A double-blinded, randomized, placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9002-9002 ◽  
Author(s):  
Sriram Yennurajalingam ◽  
Susan Frisbee-Hume ◽  
Marvin Omar Delgado-Guay ◽  
Janet Bull ◽  
Alexandria T. Phan ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Symptom Assessment ◽  
Primary Objective ◽  
Controlled Study ◽  
Advanced Cancer Patients ◽  
Double Blind ◽  
Cancer Related Fatigue ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

9002 Background: Cancer-related-fatigue (CRF) is the most common and distressing symptoms in patients with advanced cancer. Currently, there is no standard treatment for CRF. Although corticosteroids have been used in the treatment of CRF, there are no well-powered placebo-controlled trials that used a validated CRF outcome measure. The primary objective of this prospective, randomized, double-blind, placebo-controlled study is to compare the effect of DM versus placebo on CRF. Methods: Advanced cancer patients with fatigue ≥ 4/10 on the Edmonton Symptom Assessment Scale (ESAS) and at least 2 other CRF-related symptoms (pain, nausea, appetite, depression, anxiety or sleep disturbance ≥ 4/10), normal cognition, no infections and hemoglobin ≥ 9 g/L were eligible for enrollment. Patients were randomized to either receive dexamethasone 4 mg orally twice a day for 15 days (primary end point) or matching placebo. The primary outcome was the day 15 change in Functional Assessment of Chronic Illness-Fatigue (FACIT-F) subscale scores. Differences in the group means (normal distribution) were analyzed using the two-sample t-test. Results: In 83 evaluable patients (43 DM and 40 placebo), median age was 60 years, 61% were white, and 53% were female. There was no difference in the demographics and fatigue (FACIT-F subscale) between DM and placebo groups except for sex (p=0.02). The mean (SD) FACIT-F subscores at baseline and at day 15 for DM were 18 (11) and 27 (11) (p<0.001) and for placebo were 21 (9) and 24 (12) (p=0.06), respectively. Mean improvement in FACIT-F subscale was significantly higher in the DM group compared to placebo (9.6 (11) vs. 3.1 (9.7), p=0.005). We found a significant difference in ESAS physical distress (p=0.02), but no differences in ESAS overall symptom distress (p=0.11) and ESAS psychological distress (P=0.88) between DM and placebo. There were insignificantly higher numbers of grade ≥3 toxicities in patients who received DM than in patients who received placebo (20/42 vs. 18/47, p=0.37). Conclusions: Dexamethasone was more effective than placebo in reducing CRF in patients with advanced cancer. Long-term safety studies are needed.

The effect of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A double-blind placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 9062-9062
Author(s):  
Egidio Del Fabbro ◽  
Rony Dev ◽  
David Hui ◽  
J. Lynn Palmer ◽  
Eduardo Bruera
Keyword(s):  
Quality Of Life ◽  
Weight Loss ◽  
Advanced Cancer ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Well Being ◽  
Test Statistic ◽  
Double Blind ◽  
Edmonton Symptom Assessment Scale

9062 Background: Patients with advanced cancer experience anorexia and weight loss which impairs their quality of life. Prior studies suggest melatonin, a frequently used integrative medicine may attenuate weight loss, anorexia, fatigue, and depression. These studies were limited by a lack of blinding and absence of placebo controls. The primary objective of this study was to compare melatonin to placebo for appetite in patients with cachexia. Methods: A randomized, double-blind, 28 day trial of melatonin 20mg vs. placebo in patients with advanced lung or gastrointestinal cancer, appetite scores >3 on a 0 to 10 scale (10 = worst appetite) and a history of weight loss ≥ 5% within 6 months. Patients unable to maintain oral intake, thyroid or adrenal dysfunction, or with a karnofsky <40 were excluded from the study. The assessments included weight, symptom severity by Edmonton Symptom Assessment Scale (ESAS) and quality of life by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT).Differences between groups from baseline to day 28 were analyzed using one-sided two sample t tests (appetite, pain and well-being) or Wilcoxon two-sample tests for the other variables. Interim analysis at half point had a Lan-DeMets monitoring boundary with an O’Brien-Fleming stopping rule. The decision boundaries for the interim test was to accept the null hypothesis of no treatment difference (futility) if the test statistic Z < 0.39 (p ≥ 0.348). Results: After interim analysis of 48 patients, the study was closed by the Data Safety Monitoring Board for futility. There were no significant differences between groups in appetite (p=0.78), weight (p= 0.17), FAACT score (p=0.95), insomnia (p=0.62) or other symptoms measured by the ESAS from baseline to day 28.No significant toxicities were observed. Conclusions: In cachectic patients with advanced cancer, 20mg oral Melatonin at night does not improve appetite, weight or quality of life compared to placebo.

Testosterone replacement for fatigue in male hypogonadic patients with advanced cancer: A preliminary double-blind placebo-controlled trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e19643-e19643
Author(s):  
Kalyan Pulivarthi ◽  
Rony Dev ◽  
Jose Garcia ◽  
J. Lynn Palmer ◽  
Eduardo Bruera ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Controlled Trial ◽  
Depression Scale ◽  
T Test ◽  
Testosterone Replacement ◽  
Double Blind ◽  
Significant Difference ◽  
Edmonton Symptom Assessment Scale

e19643 Background: Hypogonadism affects two thirds of men with advanced cancer. Uncontrolled studies show fatigue, anorexia, depression,and insomnia are associated with low testosterone in men with cancer. Testosterone replacement improves quality of life and diminishes fatigue in patients with non-cancer conditions. The primary goal of this study was to evaluate the effect of testosterone replacement on fatigue in hypogonadal males with advanced cancer, by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)at day 29. Methods: Randomized, double-blinded placebo controlled at two centers. Clinic outpatients with advanced cancer, bioavailable testosterone (BT) <70ng/dL, hemoglobin>9g/dL, and moderate to severe fatigue assessed by a score >3/10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.Contraindications to testosterone therapy or other causes of fatigue such as hypothyroidism, hypercalcemia, or chronic kidney disease excluded subjects. Weight-based intra-muscular testosterone or a sesame seed oil placebo administered every 14 days to achieve a BT level 70-270ng/dL. Initial sample size was for fifty evaluable patients per group. One-sided t test was used to analyze differences in FACIT scores between arms. Results: Accrual was slower than anticipated with a final total of 43 eligible males randomized to testosterone(19) or placebo(24). Neither age nor site was statistically significant (<0.05) between arms. 14 placebo and 12 testosterone treated patients were evaluable for the primary outcome.No statistically significant difference was found for FACIT-F total scores between arms, with a trend for testosterone to improve scores (-5.5±19 for placebo, 3.9±14 for testosterone, p=0.09) using a one-sided t test. Adverse events were similar between groups. There were no significant differences in secondary outcomes of ESAS scores, Hospital Anxiety and Depression Scale, hand-grip or 6 minute walk. Conclusions: Testosterone replacement in hypogonadal male patients with advanced cancer had a trend to improve fatigue and quality of life in this preliminary trial.

ISA247: Quality of Life Results from a Phase II, Randomized, Placebo-Controlled Study

2008 ◽  
Vol 12 (6) ◽  
pp. 268-275 ◽  
Author(s):  
Aditya K. Gupta ◽  
Richard G. Langley ◽  
Charles Lynde ◽  
Kirk Barber ◽  
Wayne Gulliver ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Phase Ii ◽  
Life Quality ◽  
Skin Condition ◽  
Controlled Study ◽  
Double Blind ◽  
Plaque Type ◽  
Psoriasis Disability Index ◽  
Stable Plaque

Background: Psoriasis is a chronic skin condition that can negatively affect a patient's quality of life (QoL), often hindering social functioning. ISA247, a novel psoriatic agent, has shown clinical efficacy in moderate to severe psoriasis sufferers, but its effect on QoL is currently not reported. Objective: The objective of this study was to assess the effect of ISA247 on the QoL in patients with stable, plaque-type psoriasis. Methods: A phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study assessed the effects of ISA247 doses of 0.5 mg/kg/d ( n = 77) or 1.5 mg/kg/d ( n = 83) compared with placebo ( n = 41) for 12 weeks. QoL was assessed using the Dermatology Life Quality Index (DLQI) and Psoriasis Disability Index (PDI) scales. Results: ISA247 treatment (pooled groups) significantly improved QoL scores as assessed by both the DLQI and the PDI compared with those receiving placebo ( p < .05). Treatment with the higher dose of 1.5 mg/kg/d demonstrated a significantly greater response to many of the QoL scales compared with the 0.5 mg/kg/d group ( p < .05). Conclusions: ISA247 appears to improve the QoL while also providing effective treatment for chronic, moderate to severe, plaque-type psoriasis.

scholarly journals Efficacy of Lactobacillus paracasei HA-196 and Bifidobacterium longum R0175 in Alleviating Symptoms of Irritable Bowel Syndrome (IBS): A Randomized, Placebo-Controlled Study

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1159 ◽  
Author(s):  
Erin D. Lewis ◽  
Joseph M. Antony ◽  
David C. Crowley ◽  
Amanda Piano ◽  
Renu Bhardwaj ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Bifidobacterium Longum ◽  
Well Being ◽  
Lactobacillus Paracasei ◽  
Controlled Study ◽  
Double Blind ◽  
Gi Symptoms ◽  
Irritable Bowel

Specific probiotic strains can alleviate the gastrointestinal (GI) symptoms and psychiatric comorbidities of irritable bowel syndrome (IBS). In this randomized, double-blind, placebo-controlled study, the efficacy of Lactobacillus paracasei HA-196 (L. paracasei) and Bifidobacterium longum R0175 (B. longum) in reducing the GI and psychological symptoms of IBS was evaluated in 251 adults with either constipation (IBS-C), diarrhea (IBS-D), or mixed-pattern (IBS-M). Following a 2-week run-in period, participants were randomized to one of three interventions: L. paracasei (n = 84), B. longum (n = 83) or placebo (n = 81). IBS symptoms, stool frequency and consistency and quality of life were assessed by questionnaires. The differences from baseline in the severity of IBS symptoms at 4 and 8 weeks were similar between groups. Participants in this study were classified, after randomization, into subtypes according to Rome III. Within the L. paracasei group, complete spontaneous and spontaneous bowel movement frequency increased in participants with IBS-C (n = 10) after 8 weeks of supplementation (both p < 0.05) and decreased in participants with IBS-D (n = 10, p = 0.013). Both L. paracasei and B. longum supplementation improved the quality of life in emotional well-being and social functioning compared with baseline (all p < 0.05). In conclusion, L. paracasei and B. longum may reduce GI symptom severity and improve the psychological well-being of individuals with certain IBS subtypes.

scholarly journals Evaluation of efficacy and safety of montelukast and levocetirizine FDC tablet compared to montelukast and levocetirizine tablet in patients with seasonal allergic rhinitis: a randomized, double blind, multicentre, phase III trial

2020 ◽  
Vol 7 (1) ◽  
pp. 83
Author(s):  
Sagar Panchal ◽  
Saiprasad Patil ◽  
Hanmant Barkate
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Seasonal Allergic Rhinitis ◽  
Phase Iii ◽  
Fixed Dose ◽  
Controlled Study ◽  
Global Evaluation ◽  
Double Blind ◽  
Nasal Symptoms

<p class="abstract"><strong>Background:</strong> To evaluate efficacy, safety and tolerability of Montelukast 10 mg+levocetirizine 5 mg  FDC compared to either montelukast 10 mg or levocetirizine 5 mg given alone in seasonal allergic rhinitis (SAR) patients.</p><p class="abstract"><strong>Methods:</strong> Phase III, multicentre, randomized, double blind, parallel group, active controlled study was conducted in 279 SAR patients at 16 sites across India. Efficacy was assessed using daytime nasal symptoms score (Primary efficacy outcome), night-time symptoms score, daytime eye symptom score, patient's global evaluation, physician's global evaluation, rhino-conjunctivitis quality-of-life score.  </p><p class="abstract"><strong>Results:</strong> At end of treatment there was statistically significant evidence from the per protocol analysis that patients on FDC had a greater improvement in change from baseline in daytime nasal symptoms score than patients who received Montelukast (p=0.0266) or Levocetirizine (p=0.0409). These results were consistent with the Intent to treat analysis. Analysis of the secondary efficacy endpoints provided numerically greater improvement in the nighttime symptoms score, daytime eye symptoms score, and rhinoconjunctivitis quality-of-life scores in the FDC group as compared to the Montelukast group or Levocetirizine group. The FDC of Montelukast and Levocetirizine was found to be safe and generally well tolerated. The majority of adverse events were mild in severity, resolved without treatment and were unrelated to study medication.</p><p class="abstract"><strong>Conclusions:</strong> Fixed dose combination of Montelukast and Levocetirizine was safe, generally well tolerated and superior on efficacy compared to Montelukast or Levocetirizine in patients of seasonal allergic rhinitis.</p>

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