Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Neuropathy | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium gluconate | Drug | — | UNRESOLVED |
| magnesium sulfate | Drug | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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).
- interventionNames
- Drug: calcium gluconate
- Drug: magnesium sulfate
- Drug: oxaliplatin
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive placebo IV over 30 minutes immediately before and after oxaliplatin administration (part of FOLFOX chemotherapy).
- interventionNames
- Other: placebo
- Drug: oxaliplatin
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Has undergone curative resection and is considered to have stage II or III disease or completely resected stage IV disease with no evidence of residual tumor * Scheduled to receive 6 months of oxaliplatin-based adjuvant chemotherapy with 85 mg/m\^2 oxaliplatin every 2 weeks (this includes, for instance, FOLFOX4 or modified FOLFOX6) * Patients receiving bevacizumab or cetuximab in combination with FOLFOX as part of a clinical trial or clinical practice are eligible PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * WBC ≥ 3,000/mm\^3 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Serum creatinine ≤ 1.5 times ULN * Serum calcium ≤ 1.2 times ULN * Serum magnesium ≤ 1.2 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to complete questionnaires (alone or with assistance) * Able to comply with study treatment * Willing to return to enrolling institution for follow-up * Willing to provide blood sample for research purposes * No pre-existing peripheral neuropathy of any grade * No family history of a genetic/familial neuropathy * No second or third degree AV heart block or a history of second or third degree heart block * Bundle branch blocks are allowed. * No other medical conditions that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Central venous access line present, or scheduled to have a central line placed before starting chemotherapy and study treatment * No prior treatment with neurotoxic chemotherapy (e.g., oxaliplatin, cisplatin, taxanes, or vinca alkaloids) * No concurrent digitalis medication * No concurrent treatment with the anticonvulsants carbamazepine (e.g., Tegretol®), phenytoin (e.g., Dilantin®), valproic acid (e.g., Depakene®), gabapentin (Neurontin®), or pregabalin (Lyrica®) * No concurrent neurotropic agents, including venlafaxine (Effexor), desvenlafaxine (Pristiq®), milnacipran (Savella®), or duloxetine (Cymbalta) * No concurrent tricyclic antidepressants (such as amitryptilline), or any other agent specifically being given to prevent or treat neuropathy * No concurrent drugs given as a neuroprotectant
References
Publications (2)
- DERIVEDHertz DL, Dockter TJ, Satele DV, Loprinzi CL, Le-Rademacher J. Neuropathy severity at the time of oxaliplatin treatment alteration in patients with colon cancer (Alliance A151912). Support Care Cancer. 2021 Dec;29(12):7855-7863. doi: 10.1007/s00520-021-06371-x. Epub 2021 Jun 27. PMID 34176021
- DERIVEDLoprinzi CL, Qin R, Dakhil SR, Fehrenbacher L, Flynn KA, Atherton P, Seisler D, Qamar R, Lewis GC, Grothey A. Phase III randomized, placebo-controlled, double-blind study of intravenous calcium and magnesium to prevent oxaliplatin-induced sensory neurotoxicity (N08CB/Alliance). J Clin Oncol. 2014 Apr 1;32(10):997-1005. doi: 10.1200/JCO.2013.52.0536. Epub 2013 Dec 2. PMID 24297951