Research code: 3125
Ethics code: IR.IUMS.FMD.REC.1400.077
, heidari_raaz1988@yahoo.com
Abstract: (439 Views)
Background: Chemotherapy-induced peripheral neuropathy is one of the most common side effects of chemotherapy that can cause many problems for patients. Some chemotherapy drugs, such as taxanes and oxaloplatin, can cause acute neuropathy in addition to chemotherapy-induced neuropathy. Acute oxaloplatin-induced acute neurotoxicity has the same range of sensory and motor symptoms and occurs in the first hours and days after drug infusion. Some of these symptoms include sensitivity to the touch of cold objects, discomfort in drinking cold liquids, discomfort in the throat and muscle cramps. Patients with more severe neuropathy are at greater risk for chronic peripheral neuropathy. Acute neuropathy caused by paclitaxel occurs as acute pain syndrome. This pain presents as a combination of arthralgia and myalgia, which develops about 1-3 days after paclitaxel injection and usually resolves after a week. This syndrome occurs in most patients but is more severe in patients who have received higher doses of paclitaxel. The different compounds of SGLT2s have differences in terms of structure, efficacy and safety, and the preference of any of these compounds over others is not yet clear (10). Comparing the compounds of this drug group, it should be noted that the degree of glycosuria depends on the patient's glycemia and GFR, as well as the time of initiation of treatment (2). Preliminary data from patients with diabetes confirm that inhibition of SGLT2 in patients with moderate or severe renal impairment results in relatively lower glycosuria than in individuals with normal renal function. This finding confirms that low GFR in patients with diabetes is associated with a significant reduction in tubular absorption capacity, which is the predicted outcome of nephron loss. The aim of this study was to determine the effectiveness of vitamin E and placebo in improving chronic neurotoxicity induced by chemotherapy in cancer patients.
Methods: The study was performed as a clinical trial in cancer patients undergoing outpatient chemotherapy or hospitalized in Rasoul Akram Hospital. Sampling was performed randomly and easily and all patients who met the inclusion criteria were selected. Sampling was continued until the number of samples considered was completed. Chemotherapy-induced neuropathy has been defined as the frequency of different neurotoxicity intensities throughout the treatment period, the severity of which was determined based on the NCI-CTCAE_ver3 criterion. The admitted patients were divided into two groups based on Balanced Balance Randomization. The first group was treated with vitamin E and the second group was treated with placebo. The therapeutic dose of vitamin E was 400 mg daily. The treatment will last until the patient recovers and up to 6 months. The first group was treated with vitamin E and the second group was treated with placebo. The dose of vitamin E is 400 mg daily. Vitamin E and placebo were started from the beginning of treatment and continued for up to 6 months. The different intensities of the patient's neuropathy were measured in all months after treatment and the study was completed after 6 months. After treatment, the side effects of vitamin E were identified and recorded. After completing the checklists, their information was entered into spss21 software. In descriptive analysis, central indices such as mean and dispersion indices such as standard deviation (SD) were used. Independent t-test or man-whitney test was used to compare quantitative variables, chi-square or fisher exact test was used to compare qualitative variables, and correlation test was used to determine the relationship between quantitative data. Repeated Measures test was used to assess changes over time. Significance level less than 0.05 was considered.
Results: In this study, 80 patients (46 in the vitamin E group and 34 in the placebo group) were studied. Out of 80 patients, 41 (51.2%) were female and 39 (48.8%) were male. The mean age of patients was 54.52 ± 8.62 years (36-72 years). The mean age of patients in the vitamin E group was 53.24 years and in the placebo group was 56.62 years. There was no significant difference between the two groups in terms of age and gender. The severity of neuropathy was not significantly reduced in the vitamin E group compared to the placebo group. There was no significant difference between the two groups in terms of drug side effects (p = 0.207). The incidence of neuropathy was 80.4% in the vitamin E group and 82.4% in the placebo group. There was no statistically significant difference between the two groups in terms of neuropathy (p = 0.828). In the vitamin E group, 39.1% had diarrhea and in the dolaxtin group, 85.7% had drowsiness. There was no significant difference between the two groups in terms of drug side effects (p = 0.207).There was no statistically significant difference in the frequency of neuropathy between the two groups in the monthly follow-up of patients in both groups.
Conclusions. In the present study, the dose of vitamin E used in the present study was 400 mg. 80% of patients developed neuropathy despite taking vitamin E. The incidence of neuropathy in the control group was 82.4%. In the study of Afonseca et al. (19) in 38 patients (18 patients in vitamin E group and 16 patients in placebo group) the same dose of 400 mg daily was used and the incidence of neuropathy in vitamin E group and placebo were 83% and 63%, respectively. There was no statistically significant difference. In the study of Kottschade et al. (22), 189 patients in two groups were studied. There was no statistically significant difference between the incidence of neuropathy in the vitamin E group (34%) and the placebo group (29%). However, in some studies that used vitamin E at a dose of 400 mg per day, the results showed a better condition of patients taking vitamin E. In the study of Pace et al. (24), the incidence of neurotoxicity in 13 patients in vitamin E group and 14 patients in control group was 30.7% and 85.7%, respectively, which was statistically significant. In some studies, higher doses of vitamin E were used. Increasing the dose of vitamin E showed different findings. In the study of Argyriou et al. (20), a dose of 600 mg per day was used and the incidence of neurotoxicity was 25% in the vitamin E group and 73.3% in the control group. It seems that better results are obtained in cases of increasing the dose of vitamin E.
Methods: The study was performed as a clinical trial in cancer patients undergoing outpatient chemotherapy or hospitalized in Rasoul Akram Hospital. Sampling was performed randomly and easily and all patients who met the inclusion criteria were selected. Sampling was continued until the number of samples considered was completed. Chemotherapy-induced neuropathy has been defined as the frequency of different neurotoxicity intensities throughout the treatment period, the severity of which was determined based on the NCI-CTCAE_ver3 criterion. The admitted patients were divided into two groups based on Balanced Balance Randomization. The first group was treated with vitamin E and the second group was treated with placebo. The therapeutic dose of vitamin E was 400 mg daily. The treatment will last until the patient recovers and up to 6 months. The first group was treated with vitamin E and the second group was treated with placebo. The dose of vitamin E is 400 mg daily. Vitamin E and placebo were started from the beginning of treatment and continued for up to 6 months. The different intensities of the patient's neuropathy were measured in all months after treatment and the study was completed after 6 months. After treatment, the side effects of vitamin E were identified and recorded. After completing the checklists, their information was entered into spss21 software. In descriptive analysis, central indices such as mean and dispersion indices such as standard deviation (SD) were used. Independent t-test or man-whitney test was used to compare quantitative variables, chi-square or fisher exact test was used to compare qualitative variables, and correlation test was used to determine the relationship between quantitative data. Repeated Measures test was used to assess changes over time. Significance level less than 0.05 was considered.
Results: In this study, 80 patients (46 in the vitamin E group and 34 in the placebo group) were studied. Out of 80 patients, 41 (51.2%) were female and 39 (48.8%) were male. The mean age of patients was 54.52 ± 8.62 years (36-72 years). The mean age of patients in the vitamin E group was 53.24 years and in the placebo group was 56.62 years. There was no significant difference between the two groups in terms of age and gender. The severity of neuropathy was not significantly reduced in the vitamin E group compared to the placebo group. There was no significant difference between the two groups in terms of drug side effects (p = 0.207). The incidence of neuropathy was 80.4% in the vitamin E group and 82.4% in the placebo group. There was no statistically significant difference between the two groups in terms of neuropathy (p = 0.828). In the vitamin E group, 39.1% had diarrhea and in the dolaxtin group, 85.7% had drowsiness. There was no significant difference between the two groups in terms of drug side effects (p = 0.207).There was no statistically significant difference in the frequency of neuropathy between the two groups in the monthly follow-up of patients in both groups.
Conclusions. In the present study, the dose of vitamin E used in the present study was 400 mg. 80% of patients developed neuropathy despite taking vitamin E. The incidence of neuropathy in the control group was 82.4%. In the study of Afonseca et al. (19) in 38 patients (18 patients in vitamin E group and 16 patients in placebo group) the same dose of 400 mg daily was used and the incidence of neuropathy in vitamin E group and placebo were 83% and 63%, respectively. There was no statistically significant difference. In the study of Kottschade et al. (22), 189 patients in two groups were studied. There was no statistically significant difference between the incidence of neuropathy in the vitamin E group (34%) and the placebo group (29%). However, in some studies that used vitamin E at a dose of 400 mg per day, the results showed a better condition of patients taking vitamin E. In the study of Pace et al. (24), the incidence of neurotoxicity in 13 patients in vitamin E group and 14 patients in control group was 30.7% and 85.7%, respectively, which was statistically significant. In some studies, higher doses of vitamin E were used. Increasing the dose of vitamin E showed different findings. In the study of Argyriou et al. (20), a dose of 600 mg per day was used and the incidence of neurotoxicity was 25% in the vitamin E group and 73.3% in the control group. It seems that better results are obtained in cases of increasing the dose of vitamin E.
Type of Study: Research |
Subject:
Hematology & oncology
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