Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Breast Neoplasms

Carcinoma

Recurrence

Peripheral Nervous System Diseases

Pain

Breast Diseases

Skin Diseases

Neuromuscular Diseases

Anti-Arrhythmia Agents

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Reproductive Control Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Magnesium Sulfate

Calcium

Calcium, Dietary

Hormones

Anesthetics

Calcium Channel Blockers

Tocolytic Agents

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.

Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.

Calcium Gluconate

Placebo

Quality-of-Life Assessment

Questionnaire Administration

Ixabepilone

Charles Loprinzi

This randomized phase III trial studies calcium and magnesium to see how well they work in preventing peripheral neuropathy caused by ixabepilone in patients with breast cancer. Giving calcium together with magnesium may stop or delay the development of peripheral neuropathy in patients with cancer who are receiving treatment with ixabepilone. It is not yet known whether calcium and magnesium are effective in preventing peripheral neuropathy caused by ixabepilone.

PRIMARY OBJECTIVES:

I. To compare ixabepilone-induced peripheral neuropathy (sensory) as measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN)20 sensory subscale between calcium (Ca) Magnesium (Mg) and placebo arms.

SECONDARY OBJECTIVES:

I. To compare the incidence of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.

II. To compare the times to onset of CTCAE measured grade 2+ and/or grade 3+ peripheral neuropathy between CaMg and placebo arms.

III. To compare the proportion of patients requiring ixabepilone dose reductions and/or stopping ixabepilone secondary to peripheral neuropathy (sensory) between CaMg and placebo arms.

IV. To assess the toxicity of CaMg in this situation. V. To document the incidence and severity of the acute pain syndrome (APS, commonly known as arthralgias/myalgias) induced by ixabepilone.

VI. To evaluate whether CaMg will decrease the acute pain syndrome (APS). VII. To evaluate the incidence and characteristics of, and change in, ixabepilone-APS over several cycles.

VIII. To evaluate the association between the ixabepilone-APS and eventual chemotherapy-induced neuropathy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration.

ARM II: Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration.

After completion of study treatment, patients are followed up monthly for 12 months.

Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer

The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) sensor subscale score was calculated following the standard scoring algorithm and was transformed to a 0 to 100 scale with 0=Low QOL and 100=Best QOL for data analysis.

Time to onset of grade 2+ neurotoxicity was defined as time from randomization to the first occurrence of grade 2+ neurotoxicity. Time to onset of grade 3+ neurotoxicity was defined as time from randomization to the first occurrence of grade 3+ neurotoxicity.

APS was measured using the pain item which evaluated the aches/pains at its WORST in the last 24 hours in the scale of 0 to 10, with 0=no aches/pain and 10=aches/pains as bad as can be.

The outcome measures for each subsequent cycle will be analyzed in a similar fashion.

Correlation coefficients will be produced relating the worst pain scores in the first cycle of therapy and the subsequent neuropathy scores as judged from the daily and weekly questions.

National Cancer Institute (NCI)

Mayo Clinic

Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.

Overall

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Age, Continuous

Female

Male

Sex: Female, Male

United States

Region of Enrollment

Dr. Charles Loprinzi

Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20

Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale

Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version

Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy

Average Cumulative Ixabepilone Dose

Toxicity Profile of CaMg Per CTCAE Active Version

Incidence of the Acute Pain Syndrome (APS)

Severity of the Acute Pain Syndrome (APS)

Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy

Overall Study

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Calcium gluconate 0.23 mmol/ml Maxium dosage 20 ml Intra tumoral injection

In this pilot study, patients with non-curable esophageal cancer will be treated with endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where intratumoral injection with calcium is combined with locally applied electrical pulses, in order to increase calcium influx which leads to tumor necrosis.

It is hypothesized that:

* Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer
* CaEP debulks the tumor, facilitating the patient's ability to eat and drink

In this single-arm pilot study, eight patients will be treated.

Electroporation facilitates the transport of molecules across the cell membrane and into the cell by means of electrical pulses. An electric field applied to the cell destabilizes the cell membrane forming cracks, which reseals after a few minutes. During this time slot, molecules which normally are impermeable to the cell membrane are able to cross into the cytosol of the cell. Within the last ten years, studies have shown that the combination of intratumoral injection of calcium and electroporation (Calcium electroporation/CaEP) is an effective method in killing cancer cells. CaEP has been evaluated in clinical studies in colorectal cancer, carcinomas in the head and neck area, and in cutaneous metastases with promising results.

In this single-arm pilot study, eight patients with non-curable esophageal cancer will be included.

It is hypothesized that:

* Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer
* CaEP debulks the tumor, facilitating the patient's ability to eat and drink
* CaEP induces a systemic immunological response

The primary objective is to evaluate the safety of CaEP for esophageal cancer. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated.

Secondary outcomes include:

* dysphagia (Mellow Pinkas dysphagia score)
* pain (Numeric Rating Scale, NRS)
* quality of life (QoL) (EORTC QLQ-C30)
* tumor response evaluated from computed tomography (CT) and upper endoscopy
* immunologic response

Tertiary outcomes include:

✓ 90-days survival

Participants are initially treated once according to protocol. If well-tolerated, the treatment can be repeated.

Endoscopic Assisted Calcium Electroporation in Esophageal Cancer

Endoscopic Assisted Calcium Electroporation in Esophageal Cancer - a Safety Study

Registration of all AE/SAE´s within the first 14 days after treatment. The events will be assessed by CTCAE v4.0.

According to Mellow Pinkas dysphgia scale

Michael Patrick Achiam

Consultant, Ass. Professor, MD, DMSci, Ph.D., FEBS-OG

Substance Related Disorders

Adenocarcinoma

Neurotoxicity Syndromes

Syndrome

Poisoning

Chemically-Induced Disorders

Antineoplastic Agents

Micronutrients

Vitamins

Herbal and Botanical

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Folinic Acid

Cola

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).

calcium gluconate

magnesium sulfate

placebo

oxaliplatin

Charles L. Loprinzi, MD

RATIONALE: Chemoprotective drugs, such as calcium gluconate and magnesium sulfate, may prevent neurotoxicity caused by oxaliplatin. It is not yet known which administration schedule of calcium gluconate and magnesium sulfate is more effective in preventing neurotoxicity.

PURPOSE: This randomized phase III trial is studying different administration schedules of calcium gluconate and magnesium sulfate and comparing how well they work in neurotoxicity in patients with colon cancer or rectal cancer receiving oxaliplatin-based combination chemotherapy.

OBJECTIVES:

Primary

* To determine whether 2 schedules of calcium gluconate and magnesium sulfate infusions (given before and after chemotherapy or just before chemotherapy) can prevent or ameliorate chronic, cumulative oxaliplatin-induced sensory neurotoxicity in patients with colon or rectal cancer receiving adjuvant FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin.

Secondary

* To determine whether these 2 infusion schedules can increase the cumulative oxaliplatin doses that can be delivered without dose-limiting chronic neurotoxicity.
* To determine whether these 2 infusion schedules can ameliorate acute neuropathy associated with oxaliplatin.
* To determine whether these 2 infusion schedules cause adverse events.
* To investigate whether these 2 infusions schedules influence patient quality of life.
* To describe baseline and post-treatment neurological quantitative sensory testing abnormalities in the study participants.

Tertiary

* To explore if polymorphisms in the GSTP1, GSTM1, ERCC2, and XRCC1 genes are associated with early onset of oxaliplatin-induced neurotoxicity.

OUTLINE: This is a multicenter study. Patients are stratified according to age (\< 65 years vs ≥ 65 years), gender, regimen (FOLFOX4 vs modified FOLFOX6 vs other), and stage of disease (II vs III vs IV). Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive calcium gluconate IV and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).
* Arm II: Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
* Arm III: Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).

In all arms, courses repeat every 14 days for 6 months in the absence of disease progression or unacceptable toxicity.

Blood samples are collected before the second course of treatment for translational research.

Patients complete questionnaires on side effects, quality of life, and chemotherapy-induced peripheral neuropathy periodically.

After completion of study treatment, patients are followed up at 3, 6, 12, and 18 months.

Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy

A Phase III Randomized, Placebo-Controlled, Double-Blind Study of Intravenous Calcium/Magnesium in Two Different Versions to Prevent Oxaliplatin-Induced Sensory Neurotoxicity

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.

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.

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.

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.

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.

A patient has a dose-limiting chronic neurotoxicity when they discontinue oxaliplatin-based chemotherapy because of neurotoxicity.

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.

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.

Alliance for Clinical Trials in Oncology

This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for adverse event monitoring and reporting. The CTCAE version 4.0 can be accessed from the CTEP home page (http://ctep.cancer.gov).

Calcium Gluconate + Magnesium Sulfate (Pre and Post)

Placebo (Pre and Post)

Calcium Gluconate + Magnesium Sulfate (Pre), Placebo (Post)

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).\>\>

\>\> calcium gluconate: Given IV\>\>

\>\> magnesium sulfate: Given IV\>\>

\>\> oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).\>\> \>\> placebo: Given IV\>\>

\>\> oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).\>\> \>\> calcium gluconate: Given IV\>\>

\>\> magnesium sulfate: Given IV\>\>

\>\> placebo: Given IV\>\>

\>\>

\>\>

\>\>\> oxaliplatin

Total

Ecuador

Charles Loprinzi, M.D.

Two-sample t-tests or Wilcoxon rank-sum tests will be used\>\> to compare the AUC of CIPN sensory subscale between each of the two schedules of\>\> Ca/Mg infusions vs placebo arms at the 2.5% significance level. If the CIPN sensory\>\> subscales are observed to be unbalanced, we will adjust for the baseline CIPN sensory\>\> subscale scores from the AUC or incorporate them as a covariate in generalized linear\>\> regression model.

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin).\>

\>\>

\>

\>\> calcium gluconate: Given IV\>

\>\>

\>

\>\> magnesium sulfate: Given IV\>

\>\>

\>

\>\> oxaliplatin

Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).\> \>\>

\>

\>\> placebo: Given IV\>

\>\>

\>

\>\> oxaliplatin

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).\> \>\>

\>

\>\> calcium gluconate: Given IV\>

\>\>

\>

\>\> magnesium sulfate: Given IV\>

\>\>

\>

\>\> placebo: Given IV\>

\>\>

\>

\>\> oxaliplatin

All enrolled patients with Baseline and more than 1 cycle of Sensory data.

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

We will not adjust p-values (or significance level) for multiple\>\> comparisons among the numerous hypothesis testings of secondary endpoints due to the\>\> exploratory nature of these secondary analyses. The significance results from secondary\>\> analyses will be interpreted cautiously in a hypothesis-generating fashion.

All patients with Baseline and more than one cycle of EORTC CIPN-20 Autonomic data.

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

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and placebo IV over 30 minutes immediately after oxaliplatin administration (part of FOLFOX chemotherapy).\>\> \>\> calcium gluconate: Given IV\>\>

\>\> magnesium sulfate: Given IV\>\>

\>\> placebo: Given IV\>\>

\>\> oxaliplatin

All patients with at least baseline and more than 1 cycle of Motor Neuropathy data.

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

grade 2+

grade 3+

All patients that under went at least one cycle of treatment and were analyzed for chronic cumulative neurotoxicity (NCI CTCAE version 4.0 and oxaliplatin-specific neurotoxicity scale) during and after chemotherapy

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

Time to Grade 2 Neuropathy

Time to Grade 3 Neuropathy

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

All patients that discontinued treatment.

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

Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin). \>\>

* calcium gluconate: Given IV \>\>
* magnesium sulfate: Given IV \>\>
* oxaliplatin

Percentage of Patients Discontinuing Oxaliplatin-based Chemotherapy Because of Neurotoxicity

Cycle 1

Cycle 2

Cycle 3

Cycle 4

Cycle 5

Cycle 6

Cycle 7

Cycle 8

Cycle 9

Cycle 10

Cycle 11

Cycle 12

Arm I

Arm II

Arm III

Percentage of Patients With Acute Neuropathy Associated With Oxaliplatin

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

Diarrhea

Constipation

Stomach Cramping

Bowel Problems

Swallowing

Numbness in finger and toes

Tingling in finger and toes

All patients that had at least one cycle of treatment and submitted a patient-reported quality of life (QOL) as measured by the supplemental QOL questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer	NCT00998738	Neuropathy Pain Recurrent Breas... Stage IV Breast...	Calcium Glucona... Magnesium Sulfa... Placebo Quality-of-Life... Questionnaire A... Ixabepilone	18 Years -	Mayo Clinic
Endoscopic Assisted Calcium Electroporation in Esophageal Cancer	NCT04958044	Esophageal Canc...	Calcium Glucona...	18 Years - 100 Years	Rigshospitalet, Denmark
Endoscopic Assisted Calcium Electroporation in Esophageal Cancer	NCT04958044	Esophageal Canc...	Calcium Glucona...	18 Years - 100 Years	Rigshospitalet, Denmark
Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy	NCT01099449	Chemotherapeuti... Colorectal Canc... Neuropathy Neurotoxicity	calcium glucona... magnesium sulfa... placebo oxaliplatin	18 Years -	Alliance for Clinical Trials in Oncology
Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer	NCT00998738	Neuropathy Pain Recurrent Breas... Stage IV Breast...	Calcium Glucona... Magnesium Sulfa... Placebo Quality-of-Life... Questionnaire A... Ixabepilone	18 Years -	Mayo Clinic
Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation	NCT00058188	Osteoporosis Prostate Cancer	cholecalciferol calcium glucona... zoledronic acid	18 Years -	Northwestern University
Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer	NCT00998738	Neuropathy Pain Recurrent Breas... Stage IV Breast...	Calcium Glucona... Magnesium Sulfa... Placebo Quality-of-Life... Questionnaire A... Ixabepilone	18 Years -	Mayo Clinic
Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy	NCT01099449	Chemotherapeuti... Colorectal Canc... Neuropathy Neurotoxicity	calcium glucona... magnesium sulfa... placebo oxaliplatin	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for calcium gluconate