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PubMed1997

Palliative care: knowledge and attitudes of general practitioners: the results of a questionnaire after training.

A questionnaire about attitudes and knowledge in palliative care treatment was sent to 185 general practitioners who participated such a seminar some months before. The response rate was low (69/185). Pain is the most frequent symptom. All the responding doctors assume they can treat pain adequately. However, none of them can answer the knowledge questions correctly. They appreciate the palliative care organizations for the help in symptom control or for difficulties in psychological symptoms. A multifactorial etiology might explain the difficult control of asthenia. This survey agrees with other studies that knowledge in symptom control and palliative care should be improved.

Analgesics, Opioid↗
PubMed2004

A phase II evaluation of weekly paclitaxel plus carboplatin in advanced urothelial cancer.

This Phase II trial was designed to evaluate the overall objective response rate, complete response rate, efficacy, and safety of weekly paclitaxel (Taxol) and carboplatin (Paraplatin) in the treatment of advanced urothelial carcinoma. Thirty-three patients with measurable, unresectable, stage III-IV carcinoma of the urothelium were enrolled. Paclitaxel (135 mg/m2) and carboplatin (AUC=2) were given by intravenous (IV) infusion weekly x 6 followed by two weeks rest. Patients were premedicated with oral dexamethasone, diphenhydramine, and cimetadine (or equivalent). Patient characteristics included an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 (36%), one (36%), two (28%); median age 70 years (37-83); 29 (88%) male, four (12%) female; 16 (48%) patients had prior chemotherapy [eight postoperative (adjuvant), five neoadjuvant, three for metastatic disease] and eight (24%) had prior radiation therapy. Eight patients (24%) achieved objective responses, three complete responses (CR) and five partial responses (PR); one patient was not evaluable (patient died prior to first dose). The median duration of response was 13 months (range, 2-29). Nine patients (27%) had stable disease (SD) and 15 patients (45%) had progressive disease (PD). Median time to progression was 3.6 months (range, < 1-29) and median survival was 10.3 months (range, < 1-33). Grade 3 and 4 toxicities included: asthenia (46%), neutropenia (36%), leukopenia (15%), thromboembolism (12%), diarrhea (9%), nausea and vomiting (9%), hyperglycemia (7%), and neuropathy (6%). Two patients died of sepsis, one death was treatment-related. Weekly paclitaxel plus carboplatin shows promising activity; however in the current study, efficacy may have been limited by the toxicities associated with this dose-intensive regimen in an elderly, pretreated patient population with poor performance status. This regimen warrants further study, perhaps as a three out of four week regimen or at reduced doses.

Adult↗
PubMed1989

Urinary output of urodiolenone in essential hypertension.

Increased amounts of urodiolenone, an isomer of a phytoalexin, were found in the urine of 34% of patients with essential hypertension. Urodiolenone was also excreted in 70% of patients with neurocirculatory asthenia (hyperkinetic syndrome) and labile hypertension; very small quantities were found in normal subjects. When grapefruit juice, which is rich in urodiolenone, was offered to hypertensive subjects, urodiolenone excretion was much higher than the amount ingested, indicating that output was not due to precursors present in the diet.

Adolescent↗
PubMed2004

Phase I study of PKC412 (N-benzoyl-staurosporine), a novel oral protein kinase C inhibitor, combined with gemcitabine and cisplatin in patients with non-small-cell lung cancer.

BACKGROUND: PKC412 (N-benzoyl-staurosporine), an oral inhibitor of protein kinase C, is capable of cell cycle inhibition and is endowed with anti-angiogenic properties. This dose-finding phase I study was designed to establish the maximum tolerated dose (MTD) of PKC412 when combined with cisplatin-gemcitabine. PATIENTS AND METHODS: Escalating doses of PKC412 were given every day of a 4 week cycle with cisplatin 100 mg/m2 on day 2 and gemcitabine 1000 mg/m2 on days 1, 8 and 15 in patients with non-small-cell lung cancer. Dose escalation was based on a modified continuous reassessment method. RESULTS: Twenty-three patients, assigned to four cohorts receiving PKC412 at a dose ranging from 25 to 150 mg/day were evaluable. Grade 3 diarrhea occurring in 3/4 patients at cycle 1 led us to define 150 mg/day as the MTD. The MTD based on multiple cycles was redefined as 100 mg/day, since prolonged grade 2-3 nausea/vomiting leading to treatment discontinuation occurred in 3/7 patients after repeated cycles. The next lower dose tested of 50 mg/day was therefore considered as the recommended dose for phase II trials. Among 33 cycles in eight patients, toxicity consisted of grade 1-2 diarrhea (12.5%) and asthenia (50%) with only one patient experiencing grade 3 headache at this dose level. A partial response was observed in three patients. CONCLUSIONS: The results of the present study indicate that PKC412 at a dose of 50 mg/day can be safely added to cisplatin and gemcitabine in patients with advanced non-small-cell lung cancer.

Administration, Oral↗
PubMed2001

Efficacy and safety of haemodialysis treatment with the Hemocontrol biofeedback system: a prospective medium-term study.

BACKGROUND: Hypovolaemia has been implicated as a major causal factor of morbidity during haemodialysis (HD). A model biofeedback control system for intra-HD blood volume (BV) changes modelling has been developed (Hemocontrol), Hospal Italy) to prevent destabilizing hypovolaemia. It is based on an adaptive controller incorporated in a HD machine (Integra), Hospal Italy). The Hemocontrol biofeedback system (HBS) monitors BV contraction during HD with an optical device. HBS modulates BV contraction rates by adjusting the ultrafiltration rate (UFR) and the refilling rate by adjusting dialysate conductivity (DC) in order to obtain the desired pre-determined BV trajectories. METHODS: Nineteen hypotension-prone uraemic patients (seven males, 12 females; mean age 64.5+/-3.0 SEM years; on maintenance HD for 80.5+/-13.2 months) volunteered for the present prospective study that compared the efficacy and safety of bicarbonate HD treatment equipped with HBS, as a whole, with the gold-standard bicarbonate treatment equipped with a constant UFR and DC (BD). The study included three phases: Medium-term studies started with one period of 6 months of BD and always had a follow-up period of HBS treatment ranging from 14 to 30 months (mean 24.0+/-1.6); short-term studies started in September 1999, when all patients went back to BD treatment for a wash-out period of 4 weeks and a short-term study period of a further 3 weeks (phase A). Afterwards, they once again started HBS treatment for a wash-out period of 4 weeks and a short-term study period of a further 3 weeks (phase B). Every patient underwent acute studies during a single HD run, once during phase A and once in phase B. Resistance (R) and reactance (Xc) measurements were obtained utilizing a single-frequency (50 kHz) tetrapolar bioimpedance analysis (BIA). Extracellular fluid volume (ECV) was calculated from R, Xc, and height and body weight measurements using the conventional BIA regression equations. RESULTS: The overall occurrence of symptomatic hypotension and muscle cramps was significantly less in HBS treatment in both medium- and short-term studies. Self-evaluation of intra- and inter-HD symptoms (worst score=0, best score=10) revealed a statistically significant difference, as far as post-HD asthenia was concerned (6.2+/-0.2 in HBS treatment vs 4.3+/-0.1 in BD treatment, P<0.0001). No difference was observed between the two treatments when comparing pre- and post-HD lying blood pressure, heart rate, body weights and body weight changes in medium- and short-term studies. The residual BV%/ Delta ECV% ratio, expression of the vascular refilling, was significantly higher during HBS treatment in acute studies. CONCLUSIONS: HBS treatment is effective in lowering hypovolaemia-associated morbidity compared with BD treatment; this could be related to a greater ECV stability. Furthermore, HBS is a safe treatment in the medium-term because these results are not achieved through potentially harmful changes in blood pressure, body weight, and serum sodium concentration.

Aged↗
PubMed1994

Docetaxel (Taxotere): an active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group.

BACKGROUND: Docetaxel (Taxotere) is a new cytotoxic agent acting as a promoter of tubulin polymerisation with broad spectrum antitumor activity in preclinical testing. Phase I clinical trials have shown promising activity of docetaxel in patients with breast, ovarian and lung carcinomas. The objective of this open multicentre phase II study was to determine the efficacy and tolerability of this agent in patients with head and neck cancer. PATIENTS AND METHODS: Patients with proven advanced and/or recurrent squamous cell carcinoma of the head and neck without prior chemotherapy for advanced disease were eligible for this trial. Docetaxel was given at a dose of 100 mg/m2 as a 1 hour infusion every 3 weeks. Dose reductions were performed according to hematological and non-hematological toxicities. No pre-medication was given to prevent hypersensitivity reactions. RESULTS: Fourty-three patients entered this trial: 39 patients were evaluable for toxicity and 37 patients were evaluable for response. Sixty-five percent of the patients had locoregional disease, 28% had metastatic disease, and 7% had both. Twenty-five percent of the patients had previously received neo-adjuvant cisplatin-based chemotherapy. A total of 166 docetaxel courses were administered. The most frequent side-effects associated with docetaxel were alopecia (90% of the patients), asthenia (69% of the patients) and short lasting neutropenia (grade 3-4 neutropenia in 61% of the courses). Fifty-four percent of the patients experienced skin toxicity, 23% experienced hypersensitivity reaction, and 31% developed peripheral edema. Ten partial and 2 complete responses were observed, yielding a response rate of 32% (95% confidence interval 17%-47%). CONCLUSION: Docetaxel is an active drug in patients with advanced squamous cell carcinoma of the head and neck.

Adult↗
PubMed1996

Phase II study of ZD1694 in patients with advanced gastric cancer.

ZD1694 (Tomudex), a quinazoline folate analogue, is a potent and selective thymidylate synthase inhibitor. A phase II trial was undertaken to determine the efficacy and toxicity of ZD1694 in patients with advanced, measurable gastric adenocarcinoma. ZD1694, 3.0 mg/m2, was administered as a 15 min intravenous infusion every three weeks. Tumor measurements were obtained for response assessment every six weeks. Clinical examinations, adverse event assessments, and clinical laboratory tests were performed every three weeks. Thirty-three patients were enrolled. There were no objective responses to ZD1694. In general, treatment was well-tolerated. Grade 3 and 4 toxicities were infrequent, and included mucositis, nausea and vomiting, leukopenia, thrombocytopenia, and elevations of liver enzymes. Mild to moderate asthenia was common. Toxicities with ZD1694 were reversible and manageable. In conclusion, ZD1694 has an acceptable toxicity profile but shows no antitumor activity in patients with advanced gastric cancer.

Adenocarcinoma↗
PubMed2002

Cryoglobulinemia vasculitis.

Cryoglobulins are immunogloblulins that persist in the serum, precipitate with cold temperature, and resolubilize when rewarmed. Mixed cryoglobulins, composed of different immunoglobulins, with a monoclonal component in type II and only polyclonal immunoglobulins in type III, are associated with connective tissue, malignant hematologic, or obvious infectious diseases. The syndrome of mixed cryoglobulinemia represents the consequence of an immune complex-type vasculitis. It is characterized by the clinical triad of purpura, arthralgia, and asthenia, and may involve numerous organs, particularly the peripheral nervous system and the kidneys. Mixed cryoglobulinemia frequently is associated with clinical and biologic evidence of liver disease. It seems fairly clear that mixed cryoglobulinemia is often a manifestation of underlying chronic active or persistent hepatitis. In the last 10 years, many studies have demonstrated that infection with hepatitis C virus is involved in the pathogenesis of most mixed cryoglobulinemia vasculitis. This review analyzes the main published data of hepatitis C virus-mixed cryoglobulinemia, the role of liver alterations, the predictive factors associated with mixed cryoglobulin production in hepatitis C virus patients and whether its character is symptomatic, and the different types of vasculitis associated with hepatitis C virus chronic infection and their treatments.

Antiviral Agents↗
PubMed1986

Occult respiratory and autonomic dysfunction in craniovertebral anomalies and upper cervical spinal disease.

Sudden unexplained death may be seen with treatment of craniovertebral anomalies and surgery of the upper cervical spine. Death is due to sleep-induced apnea, premonitored by periods of confusion, lethargy, and asthenia. There may be associated hypotension, bradycardia, hyponatremia, hypothermia, inappropriate antidiuretic hormone secretion, and difficulty in micturition. The potential for respiratory failure may be predicted if a CO2 response test demonstrates an attenuated or abnormal response. Apnea during sleep may be reversed by arousal or may require ventilatory support for a period of time. The condition is self-limiting, but remains the major life-threatening complication. Both apnea and autonomic dysfunction are treatable and curable with appropriate diagnosis and management.

Asthenia↗
PubMed2006

Clinical safety of HIV lipopeptides used as vaccines in healthy volunteers and HIV-infected adults.

BACKGROUND: HIV-1 lipopeptides have been developed by the French National Agency for AIDS Research (ANRS) for use as candidate vaccine against HIV since 1994. Between 1996 and 2005, four different lipopeptide constructs were tested alone or in combination with recombinant canarypox HIV vaccines in 10 trials conducted in France. The aim of this study was to review clinical safety of HIV lipopeptides. METHODS: A meta-analysis based on individual subject data examined clinical safety data collected in eight preventive trials and two therapeutic trials enrolling 200 HIV-1-uninfected healthy volunteers and 48 HIV-1-infected patients. RESULTS: Of 248 trial participants, eight (3.2%) did not complete follow-up: seven among the 200 healthy volunteers, and one among the 48 HIV-1 infected patients. During the 354 person-years of follow-up, 860 lipopeptides injections were administered. Local reactions were common. However, in trials where lipopeptides were tested without adjuvant and appropriate diluents, none of the vaccinees experienced severe local response. Systemic reactions were generally mild and transient. No grade 4 reaction was reported; 18 subjects experienced grade 3 systemic events related to the vaccination, mainly asthenia, fever, headache and arthralgia. Multivariate analysis showed that female sex, number of injections and diluent (more reactions in 5% glucose alone than in combination with Tris-HCl buffer) significantly increased systemic reactions related to the vaccination. CONCLUSION: These data demonstrate that reactogenicity and systemic safety of HIV lipopeptides vaccine are acceptable both in healthy volunteers and HIV-infected adults.

AIDS Vaccines↗
PubMed2005

Hepatic plasmacytosis as a manifestation of relapse in multiple myeloma treated with thalidomide.

Thalidomide and its analogs have been extensively studied in patients with multiple myeloma. We present the case of a 58-year-old female patient with immunoglobulin GA-kappa multiple myeloma who was receiving thalidomide after failing an autologous transplant. She presented with profound asthenia and several space-occupying hepatic lesions, one of which was shown by a CT-guided percutaneous biopsy to be plasmacytoma. The patient then received bortezomib and had a transient response. Because thalidomide may also increase the expression of cytoadhesion molecules in myeloma cells and in the bone marrow microenvironment, it is possible that some patients with multiple myeloma who relapse on thalidomide may present with extramedullary plasmacytomas, as seen in this case. Therefore, whenever symptoms arise in patients with multiple myeloma who are receiving thalidomide, extramedullary plasmacytomas should be considered.

Antineoplastic Agents↗
PubMed1978

Mild phosphate diabetes in adults.

Phosphate diabetes has been considered as rare and to occur almost exclusively in children. Upon examination of adult patients with rheumatic or kidney diseases it has, however, been found that the combination of hypophosphataemia and hyperphosphaturia is not so rare. This paper deals with 24 adult patients of this type, whom we have found during 6 months. Their mean serum phosphorus concentration was 0.7 mmol/l (range 0.5--0.8). Mean phosphate clearance was 31 ml/min/1.73 m2 (range 16--51). The diagnoses were myalgia, dorsalgia (n = 7), papillitis calcificans (n = 5), prostatitis or prostate accretions (n = 4), dizziness (n = 2), kidney stones, tubular defect, interstitial nephritis, medullary sponge kidney (1 case each), two patients had transplanted kidneys. Asthenia was a common additional diagnosis. The patients' complaints have been pain in the muscles, joints, bones (18 cases), tiredness (10 cases), dizziness (8 cases), shakyness, numbness, burning sensation (7 cases), tenderness in the muscles and bones ("the princess-on-the-pea syndrome") (7 cases). The most common findings upon examination were bone tenderness (13 cases), reduced manual power (8 cases), positive Romberg test (3 cases), slight muscle atrophy (2 cases), waddling gait (2 cases). The most common findings encountered in the laboratory, besides hypophosphataemia and hyperphosphaturia, were high pH in the urine, hyperaminoaciduria, and phosphate crystals in dried urine.

Adult↗
PubMed1996

Therapeutic advances: riluzole for the treatment of motor neurone disease.

Amyotrophic laterial sclerosis is a fatal neurogenerative disorder, for which only symptomatic treatment was previously available. Riluzole was recently launched in the U.S.A. and Europe. This is the first drug to produce a modest increase in survival (approximately 3 months) in patients with this disease. Unfortunately, treatment causes a number of side-effects of which asthenia is particularly troublesome. Between 10 and 20 per cent of patients can be expected to withdraw from treatment due to these adverse effects. Data on the real time survival advantage and quality of life that can be expected whilst on treatment are needed to identify the place of riluzole in the management of this distressing disease.

Amyotrophic Lateral Sclerosis↗
PubMed2007

Clinical and pathological findings in a HERDA-affected foal for 1.5 years of life.

A Quarter horse filly bred from two horses affected with HERDA (hereditary equine regional dermal asthenia) was observed clinically and its skin histologically for the 1.5 years of its life. Severe signs of the disease did not manifest until 1.5 years of age, and were not temporally related to saddling. Histological comparison to an age-, breed- and sex-matched control did not show any consistent diagnostic features. Monitoring of the proband substantiated previous reports of (i) the autosomal recessive nature of the disease, (ii) mares affected with HERDA being able to foal without damage to the skin or reproductive tract, (iii) HERDA foals appearing phenotypically normal throughout the first year of life, and (iv) demonstrated that histological interpretation of skin specimens from grossly normal skin may be insufficient to differentiate HERDA-affected horses from controls.

Animals↗
PubMed1999

Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study.

PURPOSE: To evaluate the tolerability and safety of gabapentin (GBP) as add-on therapy for seizure control. METHODS: Conducted in an outpatient setting and reflecting usual practice, this study compared tolerability of GBP dosages < or = 1,800 versus >1,800 mg/day, when these doses were required to achieve the most effective seizure control. Two analyses of adverse events are presented: tolerability and safety. In the tolerability analysis, each patient served as his or her own control to compare the occurrence of adverse events at GBP < or =1,800 versus >1,800 mg/day. The safety analysis required patients to receive at least one dose of GBP and have a follow-up contact. RESULTS: A total of 2,216 patients enrolled in this open-label, 16-week study and were evaluable for safety. Of these, 74.0% completed the 16-week study, and 281 met the tolerability criteria. Within these 281 patients, two mutually exclusive groups were compared (a) those reporting adverse events at only < or =1,800 mg/day (low dose); and (b) those reporting adverse events at only >1,800 mg/day (high dose). Three adverse events (asthenia, headache, and dizziness) were observed in a statistically significantly larger number of patients at only the low dose than in the group reporting these same adverse events at only the high dose, suggesting that patients who tolerated GBP at < or = 1,800 mg/day did not experience a significant increase in adverse events with dosages >1,800 mg/day. Overall, 10.6% of the 2,216 patients in the safety population prematurely withdrew because of adverse events, and 3.5% discontinued because of lack of efficacy. Safety and tolerability of GBP was rated as excellent or good for 78.5% of all patients. CONCLUSIONS: Gabapentin doses >1,800 mg/day were as well tolerated as doses < or =1,800 mg/day and were not associated with more adverse events.

Acetates↗
PubMed1997

Potential side effects of dental amalgam restorations. (II). No relation between mercury levels in the body and mental disorders.

A group of 50 consecutive patients, referred for self-reported complaints which they related to dental amalgam restorations, was compared with control patients matched by age, sex and postal zip code. All patients were subjected to a psychiatric examination and a set of rating scales and questionnaires, and the symptoms were related to the mercury levels in blood, urine and hair. A psychiatric diagnosis was established in 70% of the patients in the index group versus 14% in the control group. The prevailing symptoms were anxiety, asthenia and depression. Mercury levels in blood, urine and hair were similar among index cases and controls, and were far below critical levels of mercury intoxication. There was no correlation between mercury levels and the severity of the reported symptoms. Therefore, mercury was not a likely cause of the complaints. Instead, the reported symptoms were part of a broad spectrum of mental disorders.

Affect↗
PubMed1987

Chronic fatigue and myalgia syndrome: mitochondrial and glycolytic studies in skeletal muscle.

Clinical and biochemical findings in skeletal muscle in 11 patients with chronic fatigue myalgia syndromes of unknown aetiology are reported. All patients had severe asthenia for from one to 10 years with greatly limited exercise capacity and protracted exhaustion after minor exercise. Diffuse myalgia was prominent and was exacerbated for hours to days after exercise. Assay of skeletal muscle carnitine, phosphorylase, all glycolytic enzymes and the mitochondrial marker enzymes monoamine oxidase, isocitrate dehydrogenase and cytochrome oxidase were normal. These findings lend no support to the presence of a major defect in muscle intermediary energy pathways in this syndrome.

Adult↗
PubMed2005

First-line treatment with irinotecan and raltitrexed in metastatic colorectal cancer. Mature results of a multicenter phase II study.

OBJECTIVES: The combination of irinotecan and raltitrexed is safe and active in 5-fluorouracil-refractory, metastatic colorectal cancer (CRC), with the advantage of its convenient three-weekly schedule. The aim of this multicenter phase II study was to assess its efficacy and toxicity in first-line treatment. METHODS: Between May 2000 and March 2001, 62 previously untreated patients received irinotecan (350 mg/m(2)) plus raltitrexed (3 mg/m(2)), with courses repeated every 21 days. Objective response was assessed every three courses, and treatment maintained until tumor progression or unacceptable toxicity. RESULTS: A total of 331 cycles were administered, with a median of five cycles per patient (range, 1-16). Seventeen patients achieved a partial response and 2 a complete response, for an overall intention-to-treat response rate of 30% (95% confidence interval, 18-44%). The incidence of grade 3-4 toxicity per patient was diarrhea (27%), emesis (13%), anemia (12%), neutropenia (9%), and asthenia (7%). Three patients (5%) died from treatment-related adverse events (diarrhea plus neutropenia). The median potential follow-up is now 37 months. Median survival was 12.2 months, and median time to progression was 6.3 months. CONCLUSIONS: The combination of irinotecan plus raltitrexed is an easy comfortable schedule for patients with metastatic CRC, but both efficacy and toxicity results seem suboptimal for first-line treatment.

Adult↗