5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment.

BACKGROUND: Cancer-related fatigue (CRF) is still undertreated in most patients, as evidence for pharmacological treatments is limited and conflicting. Also, the efficacy of the pharmacological agents relative to each other is still unclear. Therefore, medications that may potentially contribute to improving CRF will be investigated in this head-to-head trial. Our main objective is to compare the efficacy of methylphenidate vs. bupropion vs. ginseng vs. amantadine vs. placebo in patients with advanced cancer. METHODS: The 5-EPIFAT study is a 5-arm, randomized, multi-blind, placebo-controlled, multicenter trial that will use a parallel-group design with an equal allocation ratio comparing the efficacy and safety of four medications (Methylphenidate vs. Bupropion vs. Ginseng vs. Amantadine) versus placebo for management of CRF. We will recruit 255 adult patients with advanced cancer who experience fatigue intensity ≥ 4 based on a 0-10 scale. The study period includes a 4-week intervention and a 4-week follow-up with repeated measurements over time. The primary outcome is the cancer-related fatigue level over time, which will be measured by the functional assessment of chronic illness therapy-fatigue (FACIT-F) scale. To evaluate safety, the secondary outcome is the symptomatic adverse events, which will be assessed using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events in cancer clinical trials (PRO-CTCAE). Also, a subgroup analysis based on a decision tree-based machine learning algorithm will be employed for the clinical prediction of different agents in homogeneous subgroups. DISCUSSION: The findings of the 5-EPIFAT trial could be helpful to guide clinical decision-making, personalization treatment approach, design of future trials, as well as the development of CRF management guidelines. TRIAL REGISTRATION: IRCT.ir IRCT20150302021307N6. Registered on 13 May 2023.

Rhabdomyosarcoma mimicking lymphoma.

Background: Rhabdomyosarcoma (RMS) is a malignant soft tissue tumor that accounts for approximately one-half of soft tissue sarcomas in childhood age groups. Metastatic RMS is a rare condition that occurs in less than 25% of patients at diagnosis and can have variable clinical presentations. Case presentation: Here we report a 17-year-old boy with history of weight loss, fever and generalized bone pain admitted for severe hypercalcemia. The definite diagnosis of RMS was performed with immune-phenotyping of the metastatic lymph-node biopsy. The primary tumor site was not found. His bone scan showed diffuse bone metastasis and significant soft tissue technetium uptake due to extra-osseous calcification. Conclusion: Metastatic RMS can mimic lymphoproliferative disorders at presentation. Clinicians must be aware of this diagnosis especially in young adults.

Reversible Acute Lung Injury due to Bleomycin.

Bleomycin is a unique antibiotic agent with cytotoxic activity and is used successfully in various malignant diseases, such as Hodgkin lymphoma and germ cell tumors. Drug-induced lung injury (DILI) is one of the major limitations of bleomycin administration in particular clinical settings. The incidence varies among patients and depends on a variety of risk factors, such as cumulative drug dose, underlying malignant disease, and concurrent radiation. The clinical presentations are non-specific for bleomycin-induced lung injury (BILI), depending on the onset and severity of symptoms. There is no established guideline for the best treatment of DILI and the treatment is based on the time and severity of pulmonary symptoms. It is important to consider BILI in any patient with pulmonary clinical manifestations who has been treated with bleomycin. Here, we report a 19-year-old woman who is a known case of Hodgkin lymphoma. She was treated with a bleomycin-containing chemotherapy regimen. On the 5th month of therapy, she was admitted to hospital with severe acute pulmonary symptoms and decreased oxygen saturation. She was treated successfully with high-dose corticosteroid without any significant sequelae.

Disseminated tuberculosis with myelofibrosis presentation: a case report.

BACKGROUND: Primary myelofibrosis is a rare myeloproliferative disorder in middle-aged and old adults and should be distinguished from secondary and reactive causes of bone marrow fibrosis because, in reactive fibrosis, treatment approaches depend on the underlying etiology. CASE PRESENTATION: Here we report the case of a middle-aged Iranian man who was diagnosed and treated as primary myelofibrosis at presentation, and whose final diagnosis was disseminated tuberculosis with reactive bone marrow fibrosis. CONCLUSIONS: It is prudent to evaluate the potential causes of myelofibrosis in any patient with the diagnosis primary myelofibrosis. Tuberculosis can be an important etiology of bone marrow fibrosis, especially in endemic areas.

The Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial.

BACKGROUND: Patients undergoing bronchoscopy can experience problems such as anxiety and cough, requiring various doses of sedatives and analgesics. The purposes of this study were to investigate the effect of premedication with dextromethorphan on patients' cough and anxiety, and the use of analgesics/sedatives during flexible bronchoscopy (FB). METHODS: A randomized, double-blind, placebo-controlled, prospective study was performed to assess the effect of dextromethorphan premedication on patients who underwent diagnostic bronchoscopy. Seventy patients included in this study were randomly allocated into 2 groups: group A consisted of 35 patients who received dextromethorphan before FB; and group B consisted of 35 patients who received a placebo. A questionnaire was given to the patients and bronchoscopist about perception of cough, anxiety, and discomfort. The amount of sedative medication and lidocaine use during the procedure and the procedure time were recorded. RESULTS: The group that was premedicated with dextromethorphan had lower complaint scores, significantly less coughing, significantly less stress assessed by the patient and the physician evaluation, shorter total procedure time, and fewer midazolam requirements during FB (P-value <0.05). CONCLUSION: Considering its safety profile, dextromethorphan premedication is an effective approach to facilitate the performance of FB for the physician, and could improve patient comfort.

Advanced Cardiac Life Support Training by Problem-Based Method: Effect on the Trainee's Skills, Knowledge and Evaluation of Trainers.

BACKGROUND: Cardiopulmonary-cerebral resuscitation (CPCR) training is essential for all hospital workers, especially junior residents who might become the manager of the resuscitation team. In our center, the traditional CPCR knowledge training curriculum for junior residents up to 5 years ago was lecture-based and had some faults. This study aimed to evaluate the effect of a problem-based method on residents' CPCR knowledge and skills as well as their evaluation of their CPCR trainers. METHODS: This study, conducted at Tehran University of Medical Sciences, included 290 first-year residents in 2009-2010 - who were trained via a problem-based method (the problem-based group) - and 160 first-year residents in 2003-2004 - who were trained via a lecture-based method (the lecture-based group). Other educational techniques and facilities were similar. The participants self-evaluated their own CPCR knowledge and skills pre and post workshop and also assessed their trainers' efficacy post workshop by completing special questionnaires. RESULTS: The problem-based group, trained via the problem-based method, had higher self-assessment scores of CPCR knowledge and skills post workshop: the difference as regards the mean scores between the problem-based and lecture-based groups was 32.36 ± 19.23 vs. 22.33 ± 20.35 for knowledge (p value = 0.003) and 10.13 ± 7.17 vs. 8.19 ± 8.45 for skills (p value = 0.043). The residents' evaluation of their trainers was similar between the two study groups (p value = 0.193), with the mean scores being 15.90 ± 2.59 and 15.46 ± 2.90 in the problem-based and lecture-based groups - respectively. CONCLUSION: The problem-based method increased our residents' self-evaluation score of their own CPCR knowledge and skills.