Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0015672 (fatigue)
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An early phase II clinical study of S-1 in patients with advanced or recurrent breast cancer was undertaken by a cooperative study group (Breast Cancer Working Group) of 14 institutes in Japan. S-1 was administered twice daily at 75 or 50 mg (dose FT)/body for 28 consecutive days with 14 days rest (one course). Twenty-eight patients were enrolled, 27 were eligible for the study, and 25 were evaluable for efficacy. Four complete responses and seven partial responses were obtained, and the response rate was 40.7% (11/27) [ninety percent confidence interval for this response was 26.7-56.4%]. The major adverse reactions observed were myelosuppression represented by leukopenia 44.4% (12/27), neutropenia 40.7% (11/27), RBC decreased 37.0% (10/27), hemoglobin decreased 29.6% (8/27), anorexia 55.6% (15/27), nausea/vomiting 48.1% (13/27), and fatigue 33.3% (13/27). The results suggested that the efficacy and safety of S-1 were effective against advanced or recurrent breast cancer. The objective of study judged should be investigated in a late phase II clinical study.
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PMID:[An early phase II clinical study of S-1 in patients with breast cancer. S-1 Cooperative Study Group (Breast Cancer Working Group)]. 964 19

We gave miproxifene phosphate to six patients with recurrent breast cancer and to one patient with advanced breast cancer. This drug was orally administered at a daily dose of 20 mg in the morning, and serial blood samples were obtained just before the drug administration. Treatment was discontinued in 16 days in the patient with advanced breast cancer. Tumor response was 2 PR and 4 NC (3MR) with an efficacy rate of 29%. Adverse effects of grade 2, such as anorexia, nausea or vomiting and fatigue with grade 3 flushing and chilling were observed in the one patient with advanced breast cancer. This climacteric syndrome disappeared after cessation of administration. In one of the patients with recurrent breast cancer, a calf muscle cramp was observed. Steady plasma levels were observed in one week or two for miproxifene and in 2 to 8 weeks for desmethyl miproxifene, which were active metabolites of miproxifene phosphate. The half lives of these metabolites for disappearance were calculated in three patients. That of miproxifene was 27 to 36 hours and that of desmethyl miproxifene was 156 to 202 hours. Miproxifene phosphate is a promising drug for breast cancer, and the results of pharmacokinetics of active metabolites will suggest the time to obtain maximum efficacy and for it to disappear.
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PMID:[Steady state and disappearance of the metabolites of miproxifene phosphate in the treatment of breast cancer]. 972 50

Cancer patients are now more often long-term survivors and their needs for returning to social and productive activities have become a primary focus of intervention. The purpose of the present study was to propose an objective evaluation test for predicting endurance capacity in breast cancer patients after surgery, in order to optimize return to work or previous daily activities, and for monitoring changes during rehabilitation. Twenty female patients (mean age: 44 +/- 5), who underwent radical breast surgery 2 months before being referred to our Unit, participated in the study. In addition to the measures of the circumferences in the arm-forearm and manual muscle strength test, we performed the following functional evaluations: 0-100 Constant scale for shoulder function; instrumental evaluation of daily/occupational upper limb activities (Lido WorkSET). We monitored the mechanical parameters, the perception of effort, pain or discomfort, and the range of movement while performing a 3-minute steady daily/occupational task chosen by the subject. Patients were asked to perform the 3-minute test at three different intensities ("moderate", "somewhat hard", "hard") until the perception of fatigue, pain or discomfort was rated > 3 on the 10 point Borg's scale. The 'power-duration' product (Watt x min) defined by the three tests (see Fig. 1) represented the individual tolerable work load, since subjective indicators of pain/discomfort remained within tolerable limits during the exertion. On this basis, patients were encouraged to return to levels of daily physical activities compatible with the individual tolerable work load. The second evaluation, although no statistical analysis was performed, confirmed that the "guided" daily activity in a 2-month period increased patients' capacities and "trust" in their physical capacity.
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PMID:Work capacity of the upper limbs after mastectomy. 977 11

The cost of managing anemia with prophylactic epoetin alfa therapy versus blood transfusions in breast cancer patients receiving combination chemotherapy was studied. A retrospective study of anemia in breast cancer patients treated with four cycles of cyclophosphamide and doxorubicin with fluorouracil (CAF) or without fluorouracil (CA) was conducted. For each cycle of chemotherapy, patients were assessed for fatigue, subsequent blood transfusions administered, and potential response to and adverse effects of blood transfusions. Transfusions were given at the prescriber's discretion rather than in accordance with standard guidelines. The lowest hemoglobin concentration and hematocrit of each patient per cycle were reported. Data on these patients, along with data from published studies of prophylactic use of epoetin alfa, were used in a decision analysis of the costs associated with using epoetin alfa versus red blood cell transfusions to manage anemia. The charts of 50 patients were reviewed. In the study group, the percentage of patients with anemia and the frequency of fatigue rose with each chemotherapy cycle. In general, blood transfusions were not used. The cost of using epoetin alfa prophylactically for all four cycles was estimated at $6483 per patient for the literature-based group versus $169 for the study group. The cost of managing anemia in breast cancer patients was substantially lower when blood transfusions were used than when epoetin alfa was given prophylactically throughout four cycles of therapy with CAF or CA; the absence of standard guidelines for transfusion might have exaggerated the difference in costs.
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PMID:Cost of managing anemia with and without prophylactic epoetin alfa therapy in breast cancer patients receiving combination chemotherapy. 978 69

In Germany and the United States cancer patients are admitted to rehabilitation programmes after anti-cancer treatment. Such programmes do not exist in the Netherlands. This leads to the question of whether in the Dutch health care situation certain problems (impairments-disabilities-handicaps) exist in (ex)cancer patients that can be dealt with by a rehabilitation programme. Using theories on the development of health care needs of chronic patients and the WHO approach of Impairment, Disability and Handicap, a framework for a questionnaire was developed. This questionnaire used quality of life items, functional health items and items mainly from specific cancer-orientated instruments. One hundred and forty seven patients participated in the study. After the results of this phase were clear, a focus group approach combined with in-depth interviews was used to present patients with possible rehabilitation programmes. Questions were formulated verifying the nature of prior results, inquiring about specific elements and desired outcomes and about practical aspects concerning post-cancer rehabilitation. The population consisted mostly of breast cancer (69.4%) and bowel cancer patients (23.8%). Quality of life scored averagely moderate, not indicating large problems. About 26% of all respondents wanted to receive professional help; this was largely determined by perceived quality of life and level of social support. The desire for professional help concentrated significantly on role performance, cognition, control, family relations, psychologic and somatic aspects. The focus group discussion and interviews revealed that patients would prefer a rehabilitation programme focusing on reducing fatigue, reinforcing loadability, coping with social aspects, dietary aspects and finding new life targets. Quality of life seemed to be relatively high and only 26% of post-cancer patients indicated the need of rehabilitation. Related to a significantly lower quality of life score, improved physical loadability and psychosocial functioning (coping) should be the main outcomes of such a programme. Specific elements such as dietary advice and finding new life targets should, from the patients' perspective, be included.
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PMID:Assessment of rehabilitation needs in cancer patients. 981 54

Retinoids have been shown to be potent inhibitors of epithelial carcinogenesis. Recent evidence has demonstrated that retinoid actions are mediated through nuclear receptors, which are proteins encoded by the retinoic acid receptor and retinoid X receptor gene families. These receptors are activated by binding to specific retinoids; of the known naturally occurring retinoids, 9-cis retinoic acid is unique in its ability to bind to both receptor families. Because of its unique receptor-binding characteristics, 9-cis retinoic acid may have biological activity not possible with other retinoids. For this reason, we conducted a Phase I trial of 9-cis retinoic acid in adult patients with solid tumors. Twenty-two patients were treated twice daily with p.o. 9-cis retinoic acid at doses ranging from 20 mg/m2/day to 150 mg/m2/day. The patients had non-small cell lung cancer (n = 8), breast cancer (n = 5), colorectal cancer (n = 3), head and neck cancer (n = 2), nonmelanoma skin cancer (n = 2), or ovarian cancer (n = 2). The dose-limiting (WHO grade III) toxic effects, which occurred at the 150-mg/m2/day dose level, were headaches and diarrhea. Less severe (grades I and II) toxic effects included cheilitis, dry skin, conjunctivitis, fatigue, hypertriglyceridemia, alkaline phosphatase elevation, myalgia/arthralgia, and hypercalcemia. Of the 15 patients evaluable for tumor response, no objective responses were observed. Pharmacokinetic analysis revealed a reduction in peak 9-cis retinoic acid plasma levels with chronic administration. Based on this study, the recommended Phase II dose of 9-cis retinoic acid in adult patients with solid tumors is 100 mg/m2/day administered in a divided dose twice daily.
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PMID:Phase I trial of 9-cis retinoic acid in adults with solid tumors. 981 71

This study aimed to assess the proportion of patients with advanced breast cancer who report benefit from first-line palliative chemotherapy using a simple global measure of wellbeing and to identify factors predicting benefit. A consecutive series of women with advanced breast cancer undergoing first-line palliative chemotherapy was evaluated. The main outcome measure was patient report of overall wellbeing assessed at post-treatment interview. Physical, psychological and functional status were assessed using the Rotterdam Symptom Checklist (RSCL) on three occasions (pretreatment, at the start of the third cycle and post treatment). It was planned that treatment would be discontinued after six cycles (i.e. 18-24 weeks). One hundred and sixty patients started treatment, of whom 155 were assessable for quality of life. After treatment, 41 (26%) patients reported they felt better, 29 (19%) felt the same and 34 (22%) felt worse than they did before treatment. The other 51 (33%) patients either died or stopped attending the hospital before the post-treatment interview and were assigned as treatment 'failures'. Patients who reported feeling better after treatment had improvements in psychological distress (P < 0.0001), pain (P = 0.01), lack of energy (P = 0.02) and tiredness (P = 0.02), as well as improvement in functional status (P = 0.07). Feeling better was also correlated with disease response (P = 0.03). Feeling worse after treatment or treatment 'failure' was predicted by the pretreatment presence of a dry mouth (P = 0.003) and high levels of psychological distress (P = 0.03). Pretreatment lack of energy (P = 0.01), dry mouth (P = 0.02), presence of liver metastases (P = 0.03) and breathlessness (P = 0.03) predicted treatment 'failures'. The results of this study suggest that first-line palliative chemotherapy for advanced breast cancer confers benefit on a substantial proportion of patients, with about one-quarter feeling better after treatment and nearly a half feeling better or the same some 4-6 months after the start of treatment. Factors identified in this study may assist clinicians in deciding which patients should not be offered treatment, because of high risk of feeling worse or treatment 'failure'. This work now needs to be validated on a further cohort of women receiving chemotherapy for advanced breast cancer.
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PMID:Do patients with advanced breast cancer benefit from chemotherapy? 983 82

Cancer patients (n = 913) who received treatment within the previous 2 years were interviewed to quantify reports of symptoms associated with cancer, measure the impact of symptoms on lifestyles, document experiences with accessing information and treatment for cancer and its symptoms, and record attitudes about the level of care received. Cancer patients were primarily recruited through newspaper ads placed throughout Canada and asked to complete a self-report questionnaire. Patients called a toll-free number and were interviewed to ensure eligibility. Most respondents were female (66%) with breast cancer (64%). Prostate cancer (40%) was the most common diagnosis among males. Almost all respondents (94%) reported experiencing one or more symptoms. Fatigue and anxiety were the most frequently reported symptoms (78% and 77%, respectively). Fatigue was most likely to be self-rated as moderate to severe and was most likely to interfere in normal daily activities. Respondents who experienced fatigue reported a more frequent use of healthcare services (including complementary therapies) than those who did not experience fatigue. Half of the respondents reported trying to find information on fatigue, but only half of these said they had obtained information. The most helpful sources of information were nurses, specialists, and other cancer patients. Respondents were more likely to be dissatisfied with their treatments for their symptoms than for their cancer. This survey indicates that most cancer patients experience symptoms related to the disease and its treatment. The most prevalent symptoms are fatigue and anxiety; fatigue is the most debilitating.
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PMID:A Canadian survey of cancer patients' experiences: are their needs being met? 984 24

1. Women with breast cancer are at high risk for fatigue as a side effect of treatment with surgery, radiation, and chemotherapy. The risk is compounded by the multiple roles of women who return to work during treatment. 2. The fatigue experience includes a physical component of decreased functional status, an affective component of emotional distress, and a cognitive component of difficulty concentrating. These characteristics of fatigue may present significant challenges for employees. 3. The Family Medical Leave Act provides 12 weeks of unpaid leave to receive medical treatment and/or recover from treatment for breast cancer. 4. The nurse in the workplace can assess and monitor the effects of fatigue and teach employees to manage fatigue through energy conservation, effective use of energy, and health promotion activities to restore energy levels.
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PMID:Breast cancer and fatigue: issues for the workplace. 992 3

To investigate the safety of rapid infusion of alendronate, we used alendronate therapy for 11 breast cancer patients with bone metastasis. Of the 11 patients, only 1 had hypercalcemia and the remaining 10 normocalcemia. Rapid infusion of alendronate consisted of an administration of alendronate 10 mg diluted in 100 ml saline in 30 minutes, and was repeated every two weeks. Each patient underwent 1 to 9 alendronate treatments. During alendronate therapy, only one patient complained of general fatigue, and the remaining 10 showed no alendronate-induced clinical symptoms. Rapid infusion of alendronate caused an increase in BUN level in two patients receiving intravenous hyperalimentation (IVH), a mild increase of GOT level in one, and a decrease of serum phosphorus level in two receiving IVH. However, no increase was found in serum creatinine and GOT levels. In addition, no patients showed alendronate-induced hypocalcemia. In conclusion, rapid infusion of alendronate brings about no major adverse effects, and makes it easier for many patients with bone metastasis to receive alendronate therapy on an outpatient basis.
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PMID:[A study of the safety of rapid infusion of alendronate]. 1006 98


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