Page last updated: 2024-10-27

fluorouracil and Muscle Cramp

fluorouracil has been researched along with Muscle Cramp in 3 studies

Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.
5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth.

Muscle Cramp: A sustained and usually painful contraction of muscle fibers. This may occur as an isolated phenomenon or as a manifestation of an underlying disease process (e.g., UREMIA; HYPOTHYROIDISM; MOTOR NEURON DISEASE; etc.). (From Adams et al., Principles of Neurology, 6th ed, p1398)

Research Excerpts

ExcerptRelevanceReference
"There were no statistically significant neuropathy differences among the study arms as measured by the primary end point or additional measures of neuropathy, including clinician-determined measurement of the time to grade 2 neuropathy by using the National Cancer Institute Common Terminology Criteria for Adverse Events scale or an oxaliplatin-specific neuropathy scale."2.79Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). ( Atherton, P; Dakhil, SR; Fehrenbacher, L; Flynn, KA; Grothey, A; Lewis, GC; Loprinzi, CL; Qamar, R; Qin, R; Seisler, D, 2014)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's3 (100.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Basset-Seguin, N1
Loprinzi, CL1
Qin, R1
Dakhil, SR1
Fehrenbacher, L1
Flynn, KA1
Atherton, P1
Seisler, D1
Qamar, R1
Lewis, GC1
Grothey, A1
Uña, E1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity[NCT01099449]Phase 3362 participants (Actual)Interventional2010-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Area Under the Curve (AUC) of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Motor Neuropathy Subscale Scores

The oxaliplatin-induced motor neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) motor neuropathy subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN motor neuropathy subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 motor neuropathy subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 motor neuropathy subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 Months

InterventionAUC QLQ-CIPN20 Motor Neuropathy Score (Mean)
Calcium Gluconate + Magnesium Sulfate (Pre and Post)94.1
Placebo (Pre and Post)93.3
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)91.6

Area Under the Curve (AUC) of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) Autonomic Neuropathy Subscale Scores

The oxaliplatin-induced autonomic neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) autonomic subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN autonomic subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 autonomic subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 autonomic subscale as the endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 months

Interventionscore on a scale (Mean)
Calcium Gluconate + Magnesium Sulfate (Pre and Post)89.8
Placebo (Pre and Post)86.7
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)84.5

Cumulative Oxaliplatin Doses That Can be Administered Without Dose-limiting Chronic Neurotoxicity

A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity. (NCT01099449)
Timeframe: Up to 18 months

InterventionDoses (Mean)
Calcium Gluconate + Magnesium Sulfate (Pre and Post)8.1
Placebo (Pre and Post)8.4
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)8.0

Incidence of Calcium Gluconate and Magnesium Sulfate-induced Adverse Events as Measured by CTCAE Version 4.0

(NCT01099449)
Timeframe: Up to 18 months

InterventionNumber of reported Adverse Events (Number)
Arm I290
Arm II259
Arm III296

Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity

(NCT01099449)
Timeframe: Up to 18 months

Interventionpercentage of patients (Number)
Calcium Gluconate + Magnesium Sulfate (Pre and Post)34.7
Placebo (Pre and Post)27.7
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)30.5

Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy

The oxaliplatin-induced sensory neuropathy as repeatedly measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Chemotherapy-induced peripheral neuropathy (EORTC QLQ-CIPN20) sensory subscale during the chemotherapy. This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the CIPN20 sensory subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) of CIPN20 sensory subscale as the primary endpoint. This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 months

Interventionscore on a scale (Mean)
Calcium Gluconate + Magnesium Sulfate (Pre and Post)89.2
Placebo (Pre and Post)88.3
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)87.1

Area Under the Curve (AUC) of Patient-reported Quality of Life (QOL) as Measured by the Supplemental QOL Questionnaire

This is a multivariate repeated measurement of CIPN with possibly variable cycles for every patient. The supplemental quality of life (QOL) subscale will be calculated by standard scoring algorithm and converted to 0-100 scale, where higher scores represent a higher quality of life. Rather than choosing the subscale at a fixed cycle of chemotherapy, we will adopt a summary measure, area under the curve (AUC) . This AUC will be prorated by the number of chemotherapy cycles patients received. (NCT01099449)
Timeframe: Up to 18 months

,,
Interventionscore on a scale (Mean)
DiarrheaConstipationStomach CrampingBowel ProblemsSwallowingNumbness in finger and toesTingling in finger and toes
Arm I86.790.192.889.191.283.478.9
Arm II86.288.890.688.587.681.876.5
Arm III84.588.089.484.686.780.076.3

Percentage of Patients Experiencing Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity.

Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. (NCT01099449)
Timeframe: Up to 18 months

,,
Interventionpercentage of patients (Number)
grade 2+grade 3+
Calcium Gluconate + Magnesium Sulfate (Pre and Post)42.77.7
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)46.17.8
Placebo (Pre and Post)44.87.8

Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin

This is the percent of patients who scored >=50 in all sequences of all cycles by arm for side effect Q1: Sensitivity to touching cold. This is a> repeated measurement of CIPN with possibly variable cycles for every patient. The CIPN subscale will be calculated by standard scoring algorithm and converted to 0-100 scale. Where 0 is no sensitivity and 100 is as bad as it can be. (NCT01099449)
Timeframe: Up to 18 months

,,
Interventionpercentage of patients (Number)
Cycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6Cycle 7Cycle 8Cycle 9Cycle 10Cycle 11Cycle 12
Arm I102432343431353234292827
Arm II132733373337343437393945
Arm III142832363933343332303332

Time to Onset of Grade 2+ and Grade 3+ Chronic Cumulative Neurotoxicity and the Duration of the Chronic Cumulative Neurotoxicity During and After Chemotherapy

Time to onset of grade 2+ and grade 3+ chronic cumulative neurotoxicity, the duration of the chronic cumulative neurotoxicity during and after the adjuvant oxaliplatin-based chemotherapy. Grades are determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.0) and oxaliplatin-specific neurotoxicity scale, during and after chemotherapy. Higher grades symbolize greater severity of the adverse event. (NCT01099449)
Timeframe: Up to 18 months

,,
InterventionDays (Median)
Time to Grade 2 NeuropathyTime to Grade 3 Neuropathy
Calcium Gluconate + Magnesium Sulfate (Pre and Post)171NA
Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)171NA
Placebo (Pre and Post)173208

Reviews

1 review available for fluorouracil and Muscle Cramp

ArticleYear
    Annales de dermatologie et de venereologie, 2018, Volume: 145 Suppl 5

    Topics: Alopecia; Anilides; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Basal Cel

2018

Trials

1 trial available for fluorouracil and Muscle Cramp

ArticleYear
Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance).
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014, Apr-01, Volume: 32, Issue:10

    Topics: Administration, Intravenous; Aged; Antineoplastic Combined Chemotherapy Protocols; Calcium; Cold Tem

2014

Other Studies

1 other study available for fluorouracil and Muscle Cramp

ArticleYear
Atypical presentation of acute neurotoxicity secondary to oxaliplatin.
    Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2010, Volume: 16, Issue:4

    Topics: Adenocarcinoma; Angiogenesis Inhibitors; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized;

2010