NCT01099449 is a Phase 3 clinical trial of calcium gluconate in Chemotherapeutic Agent Toxicity, sponsored by Alliance for Clinical Trials in Oncology.

Who is sponsoring NCT01099449?

NCT01099449 is sponsored by Alliance for Clinical Trials in Oncology.

What drugs are being tested in NCT01099449?

Interventions in NCT01099449: calcium gluconate, magnesium sulfate, placebo, oxaliplatin.

What condition does NCT01099449 study?

NCT01099449 studies Chemotherapeutic Agent Toxicity, Colorectal Cancer, Neuropathy, Neurotoxicity.

Is NCT01099449 still recruiting?

NCT01099449 is currently completed. Last updated 1 November 2022.

Are results published for NCT01099449?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-01 · How we verify

NCT01099449

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 1 November 2022

What this trial tests

Phase 3 trial testing calcium gluconate in Chemotherapeutic Agent Toxicity in 362 participants. Completed in 1 March 2013.

Timeline

1 June 2010

Primary endpoint
1 December 2012

1 March 2013

Quick facts

Lead sponsor	Alliance for Clinical Trials in Oncology
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	362
Start date	1 June 2010
Primary completion	1 December 2012
Estimated completion	1 March 2013
Sites	405 locations across United States, Puerto Rico

Drugs / interventions tested

calcium gluconate (CALCIUM GLUCONATE) — full drug profile →
magnesium sulfate — full drug profile →
placebo
oxaliplatin (Oxaliplatin) — full drug profile →

Conditions studied

Chemotherapeutic Agent Toxicity — all drugs for Chemotherapeutic Agent Toxicity →
Colorectal Cancer — all drugs for Colorectal Cancer →
Neuropathy — all drugs for Neuropathy →
Neurotoxicity — all drugs for Neurotoxicity →

Sponsor

Alliance for Clinical Trials in Oncology

Who can join

18 and older, any sex, with Chemotherapeutic Agent Toxicity or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sensory Area Under the Curve(AUC) Score. Oxaliplatin-induced Sensory Neuropathy as Repeatedly Measured by the EORTC QLQ-CIPN20 Sensory Subscale During Chemotherapy
Time frame: Up to 18 months
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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance).
Loprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, et al · · 2014 · cited 158× · PMID 24297951 · DOI 10.1200/jco.2013.52.0536
Targeting strategies for oxaliplatin-induced peripheral neuropathy: clinical syndrome, molecular basis, and drug development.
Yang Y, Zhao B, Gao X, Sun J, et al · · 2021 · cited 47× · PMID 34686205 · DOI 10.1186/s13046-021-02141-z
Rasch model-based testing of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) using Alliance for Clinical Trials in Oncology (Alliance) A151408 study data.
Smith EML, Zanville N, Kanzawa-Lee G, Donohoe C, et al · · 2019 · cited 18× · PMID 30460399 · DOI 10.1007/s00520-018-4553-y
Genetic Predictors of Chemotherapy-Induced Peripheral Neuropathy from Paclitaxel, Carboplatin and Oxaliplatin: NCCTG/Alliance N08C1, N08CA and N08CB Study.
Adjei AA, Lopez CL, Schaid DJ, Sloan JA, et al · · 2021 · cited 13× · PMID 33802509 · DOI 10.3390/cancers13051084
Neuropathy severity at the time of oxaliplatin treatment alteration in patients with colon cancer (Alliance A151912).
Hertz DL, Dockter TJ, Satele DV, Loprinzi CL, et al · · 2021 · cited 11× · PMID 34176021 · DOI 10.1007/s00520-021-06371-x
Emerging Approaches for the Management of Chemotherapy-Induced Peripheral Neuropathy (CIPN): Therapeutic Potential of the C5a/C5aR Axis.
Spera MC, Cesta MC, Zippoli M, Varrassi G, et al · · 2022 · cited 10× · PMID 36098939 · DOI 10.1007/s40122-022-00431-8
Colorectal Cancer at the Crossroads: The Good, the Bad, and the Future of Platinum-Based Drugs.
Kee JX, Yau JNN, Kumar Muthuramalingam RP, Wang X, et al · · 2025 · cited 6× · PMID 40985211 · DOI 10.1021/acs.chemrev.5c00041
Neurological safety of oxaliplatin in patients with uncommon variants in Charcot-Marie-tooth disease genes.
Le-Rademacher JG, Lopez CL, Kanwar R, Major-Elechi B, et al · · 2020 · cited 2× · PMID 32018185 · DOI 10.1016/j.jns.2020.116687

Verify or expand the search:

Other recruiting trials for Chemotherapeutic Agent Toxicity

Currently open trials in the same condition.

NCT06387901 — Investigating Paclitaxel Toxicity in Breast Cancer: the Roles of Physical Activity and Body Composition. · recruiting
NCT06077123 — Telemonitoring Platforms and Chemotherapy-Associated Toxicity · NA · recruiting

Other Alliance for Clinical Trials in Oncology trials

Trials by the same sponsor.

NCT07293247 — A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After · Phase 2 · not yet recruiting
NCT07283939 — Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays · NA · recruiting
NCT07059884 — Distance-Based Exercise to Preserve Function and Prevent Disability · NA · recruiting
NCT07321652 — Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated C · Phase 3 · not yet recruiting
NCT07091617 — Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01099449 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology
Last refreshed: 1 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01099449.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing