Modafinil for the Treatment of Fatigue in Lung Cancer: Results of a Placebo-Controlled, Double-Blind, Randomized Trial

2014 ◽  
Vol 32 (18) ◽  
pp. 1882-1888 ◽  
Author(s):  
Anna Spathis ◽  
Kate Fife ◽  
Fiona Blackhall ◽  
Susan Dutton ◽  
Ronja Bahadori ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Performance Status ◽  
Evidence Base ◽  
Double Blind ◽  
Fatigue Score ◽  
Intention To Treat ◽  
Cancer Related Fatigue ◽  
Patient Reported ◽  
Secondary Outcomes ◽  
And Performance

Purpose Fatigue is a distressing symptom occurring in more than 60% of patients with cancer. The CNS stimulants modafinil and methylphenidate are recommended for the treatment of cancer-related fatigue, despite a limited evidence base. We aimed to evaluate the efficacy and tolerability of modafinil in the management of fatigue in patients with non–small-cell lung cancer (NSCLC). Patients and Methods Adults with advanced NSCLC and performance status of 0 to 2, who were not treated with chemotherapy or radiotherapy within the last 4 weeks, were randomly assigned to daily modafinil (100 mg on days 1 to 14; 200 mg on days 15 to 28) or matched placebo. The primary outcome was change in Functional Assessment of Chronic Illness Therapy (FACIT) –Fatigue score from baseline to 28 days, adjusted for baseline fatigue and performance status. Secondary outcomes included safety and patient-reported measures of depression, daytime sleepiness, and quality of life. Results A total of 208 patients were randomly assigned, and 160 patients (modafinil, n = 75; placebo, n = 85) completed questionnaires at both baseline and day 28 and were included in the modified intention-to-treat analysis. FACIT-Fatigue scores improved from baseline to day 28 (mean score change: modafinil, 5.29; 95% CI, 2.57 to 8.02; placebo, 5.09; 95% CI, 2.54 to 7.65), but there was no difference between treatments (0.20; 95% CI, −3.56 to 3.97). There was also no difference between treatments for the secondary outcomes; 47% of the modafinil group and 23% of the placebo group stated that the intervention was not helpful. Conclusion Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting. Its use was associated with a clinically significant placebo effect.

Patient-reported symptom burden and quality of life in advanced lung cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16570-e16570
Author(s):  
Shrividya Iyer ◽  
Alex Rider ◽  
Gavin Taylor-Stokes ◽  
Adam Roughley
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Performance Status ◽  
Symptom Burden ◽  
Shortness Of Breath ◽  
Patient Reported ◽  
And Performance ◽  
Loss Of Appetite ◽  
Nsclc Patients

e16570 Background: The main objective of our study was to assess patient reported symptom burden and impact on quality of life in advanced non small cell lung cancer (NSCLC) patients in the United States. Methods: Patients with advanced (stage IIIB/IV) NSCLC (N=450) were recruited with informed consent in a nationwide (US) lung cancer study from Oct-Dec 2011. Patient reported symptoms were assessed using the Lung Cancer Symptom Scale (LCSS) on a 0-100 visual analogue scale and included six symptoms: fatigue, appetite loss, shortness of breath, cough, pain and blood in sputum. An average symptom burden index was calculated. Quality of life was assessed using the Functional Assessment of Cancer Therapy- Lung (FACT-L).Higher scores indicate higher symptom severity on the LCSS and better quality of life on the FACT-L. Correlation between the total FACT-L score and LCSS symptom burden index was assessed. A multivariate regression analysis was performed with FACT-L total score as the dependent variable and LCSS symptom scores as predictors controlling for age, gender, stage and performance status. Results: Majority of the patients were male (59%), Caucasian (74%), smokers/ex-smokers (78%) with an average age of 64 years. Proportion of patients reporting each lung cancer symptom was: Fatigue (100%), loss of appetite (97%), shortness of breath (95%), cough (93%), pain (92%) and blood in sputum (63%). The average (SD) symptom burden index was 42.3 (21.5).The mean± SD severity scores on symptoms were: fatigue (53.2±24.7), loss of appetite (48.1±25.8), cough (48.4±29.9), shortness of breath (44.7± 27), pain (39.7± 28.1) and blood in sputum (18.4±23.6). The average (SD) FACT-L score was 71.7 (25.3). A significant negative correlation was found between the LCSS symptom burden index and FACT-L scores (ρ= -0.82; p<0.001). Loss of appetite (β=-0.204; p<0.001), cough (β= -0.145; p<0.01), pain (β=-0.265; p<0.001), shortness of breath (β = -0.145; p<0.01), age (β= 0.217; p<0.05) and performance status (β = 0.283; p<0.001) were found to be significant predictors of quality of life. Conclusions: Cough, pain, shortness of breath and loss of appetite contribute to symptom burden and have a significant negative impact on quality of life in advanced NSCLC patients.

Patient-Centered Palliative Care for Patients With Advanced Lung Cancer

2022 ◽  
Author(s):  
Jennifer S. Temel ◽  
Laura A. Petrillo ◽  
Joseph A. Greer
Keyword(s):  
Lung Cancer ◽  
Palliative Care ◽  
Checkpoint Inhibitors ◽  
Care Delivery ◽  
Cancer Therapeutics ◽  
Evidence Base ◽  
Advanced Lung Cancer ◽  
Care Needs ◽  
Patient Centered ◽  
Patient Reported

The evidence base demonstrating the benefits of an early focus on palliative care for patients with serious cancers, including advanced lung cancer, is substantial. Early involvement of specialty-trained palliative care clinicians in the care of patients with advanced lung cancer improves patient-reported outcomes, such as quality of life, and health care delivery, including hospice utilization. Since the time that many of these palliative care trials were conducted, the paradigm of cancer care for many cancers, including lung cancer, has changed dramatically. The majority of patients with advanced lung cancer are now treated with immune checkpoint inhibitors or targeted therapies, both of which have had a significant impact on patient's experience and outcomes. With this changing landscape of lung cancer therapeutics, patients are facing new and different challenges, including dealing with novel side effect profiles and coping with greater uncertainty regarding their prognosis. Patients who are living longer with their advanced cancer also struggle with how to address survivorship issues, such as sexual health and exercise, and decision making about end-of-life care. Although palliative care clinicians remain well-suited to address these care needs, they may need to learn new skills to support patients treated with novel therapies. Additionally, as the experience of patients with advanced lung cancer is becoming more varied and individualized, palliative care research interventions and clinical programs should also be delivered in a patient-centered manner to best meet patient's needs and improve their outcomes. Tailored and technology-based palliative care interventions are promising strategies for delivering patient-centered palliative care.

Predictors of early hospice or death in patients with inoperable lung cancer treated with curative intent.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20525-e20525
Author(s):  
Anna Mary Brown Laucis ◽  
Kimberly A. Hochstedler ◽  
Thomas Pence Boike ◽  
Benjamin Movsas ◽  
Craig William Stevens ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Logistic Regression ◽  
Predictive Model ◽  
Performance Status ◽  
Ecog Performance Status ◽  
Curative Intent ◽  
Heart Dose ◽  
Patient Reported ◽  
Mean Heart Dose ◽  
Nsclc Patients

e20525 Background: Treatment for inoperable stage II-III non-small cell lung cancer (NSCLC) involves aggressive chemo-radiotherapy (CRT). While outcomes have improved with immunotherapy, some patients transition to hospice or die early in their treatment course. To help identify these patients, we developed a predictive model for early poor outcomes in NSCLC patients treated with curative intent. Methods: In a statewide consortium involving 27 sites, information was collected prospectively on stage II-III NSCLC patients who received curative CRT from April 2012 to November 2019. We defined an early poor outcome as termination of treatment due to hospice enrollment or death within 5 months of initiating radiation therapy. Potential predictors included clinical characteristics and patient reported outcomes (PROs) from validated questionnaires. Logistic regression models were used to assess potential predictors and build predictive models. Multiple imputation was used to handle missing data. We used Lasso regularized logistic regression to build a predictive model with multiple predictor variables. Results: Of the total of 2267 included patients, 128 patients discontinued treatment early due to hospice enrollment or death. The mean age of the 128 patients was 71 years old (range 48-91) and 59% received concurrent chemotherapy. Significant uni-variable predictors of early hospice or death were advanced age, worse ECOG performance status, high PTV volume, short distance to normal tissue critical structures, high mean heart dose, uninsured status, lower scores on the Functional and Physical Well-Being scale and the Lung Cancer Symptoms sub-scale of the FACT-L quality of life instrument, as well as higher levels of patient-reported lack of energy, cough, and shortness of breath. The best predictive model included age, ECOG performance status, PTV volume, mean heart dose, patient insurance status, and patient-reported lack of energy and cough. The pooled estimate of area under the curve (AUC) for this multivariable model was 0.71, with a negative predictive value of 95%, specificity of 97%, positive predictive value of 23%, and sensitivity of 16% at a predicted risk threshold of 20%. Conclusions: Our models identified a combination of clinical variables and PROs that may help identify individuals with inoperable NSCLC undergoing curative intent chemo-radiotherapy who are at a high risk of early hospice enrollment or death. These preliminary results are encouraging and warrant further evaluation in a larger cohort of patients.

Assessment of cancer-related fatigue among Jordanian patients: a cross-sectional survey

2020 ◽  
Vol 29 (2) ◽  
pp. 111-117
Author(s):  
Osama Mohammad Abu-Taha ◽  
Mohammad Ibrahim Al Qadire ◽  
Mahmoud Maharmeh ◽  
Mansour Saleh Alyami
Keyword(s):  
Lung Cancer ◽  
Survey Design ◽  
Healthcare Providers ◽  
Pharmacological Interventions ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Fatigue Score ◽  
Factors Associated ◽  
Cancer Related Fatigue ◽  
Several Variables

Background: Cancer-related fatigue (CRF) is considered to be one of the most common symptoms reported by cancer patients. However, little information is available regarding the variables associated with CRF among Jordanian patients. Aims: To assess the prevalence of CRF and explore its predictors among Jordanian patients. Methods: A cross-sectional survey design was used. Findings: Of the 240 patients surveyed, 210 (87.5%) had fatigue at the time of the survey. The total mean fatigue score was 6.2 (SD=1.7) out of a maximum possible score of 10. The results also showed that being unemployed, with longer hospitalisation, low haemoglobin, and having lung cancer seem to predict higher levels of CRF. Conclusion: Several variables and factors associated with CRF were identified. In response to these results, healthcare providers should pay more attention to CRF, which needs to be assessed on a regular basis and to be managed with the available pharmacological and non-pharmacological interventions.

scholarly journals Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Zhaoqin Wang ◽  
Shanshan Li ◽  
Luyi Wu ◽  
Qin Qi ◽  
Huirong Liu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Primary Outcome ◽  
Acupuncture Treatment ◽  
Acupuncture Group ◽  
Randomized Controlled ◽  
Link Type ◽  
Cancer Related Fatigue ◽  
Secondary Outcomes

Abstract Background Fatigue is one of the primary symptoms in lung cancer, with a prevalence of 88.0% in survivors of cancer, and an even higher prevalence post resection surgery. Effective fatigue control after lung cancer surgery is important for patient recovery and quality of life. Some studies have shown that acupuncture might be effective in treating cancer-related fatigue; however, randomized controlled trials (RCTs) of suitable sample size are limited. Method/design This is a multi-center, patient-blinded RCT. A total of 320 eligible patients will be recruited in four centers and randomly assigned to either the acupuncture group or the sham acupuncture group in a 1:1 ratio. Treatment will be given twice per week for 12 sessions. Treatment will be given at acupoints GV20, GV29, CV12, CV6, CV4, and bilateral LI4, LR3, SP6, ST36. The primary outcome will be assessed using the Chinese version of The Brief Fatigue Inventory. The secondary outcomes will be measured using The European Organization for Research and The Treatment of Cancer Quality of Life Questionnaire, and the Hamilton Rating Scale for Depression. The primary outcome will be assessed at all main points (baseline, the 3rd week, the 6th week, and at follow up time points) and the secondary outcomes will be assessed at baseline and the 6th week. Intention-to-treat analysis will be used in this RCT. Discussion This trial protocol provides an example of the clinical application acupuncture treatment in the management of lung cancer-related fatigue. If the acupuncture treatment protocol confirms that acupuncture is an effective and safe option for lung cancer-related fatigue, it can be adopted as a standardized treatment. Trial registration Chinese Clinical Trial Registry, ChiCTR1900022831. Registered on 27 April 2019. URL: http://www.chictr.org.cn/showproj.aspx?proj=37823

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