NeuropathyPhase 3NCT00998738
Calcium and Magnesium in Preventing Peripheral Neuropathy Caused by Ixabepilone in Patients With Breast Cancer
A Phase 3 study testing Calcium Gluconate, Magnesium Sulfate and Quality-of-Life Assessment in people with Neuropathy and Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Pain, Recurrent Breast Carcinoma
- What is being tested?
- Calcium Gluconate, Magnesium Sulfate and Quality-of-Life Assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jan 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease
- Serum calcium =< 1.2 x upper normal limit (UNL)
- Serum magnesium =< UNL
- Serum creatinine =< 1.5 x UNL
- Ability to sign informed consent and understand the nature of a placebo-controlled trial
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
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- Ability to complete questionnaire(s) by themselves or with assistance
- Life expectancy >= 4 months
- Presence of a central line
Who cannot join
- Pre-existing history of peripheral neuropathy >= grade 2 (National Cancer Institute [NCI] CTCAE Active Version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
- Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy
- Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
- Any of the following:
- Pregnant women
- Nursing women
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- Women of childbearing potential (per physician judgment)
- Diagnosed diabetes requiring insulin or oral hypoglycemic medications
- Receiving digoxin or digitoxin
- History of heart block (any degree)
- Current treatment for arrhythmias
- Concurrent treatment with other neuropathic chemotherapy agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Neuropathy, Pain, Recurrent Breast Carcinoma, Stage IV Breast Cancer
- Being tested
- Calcium Gluconate, Magnesium Sulfate, Placebo, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium GluconateDrug
Also called Calcium D-gluconate, Calglucon
Given IV
Magnesium SulfateDrug
Also called Magnesium SO4, Magnesium Sulfate whiskers
Given IV
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given IV
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
IxabepiloneDrug
Also called IXEMPRA
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (calcium gluconate, magnesium sulfate) | Experimental | Patients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration. Receives: Drug: Calcium Gluconate; Drug: Magnesium Sulfate; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Ixabepilone |
| Arm II (placebo) | Placebo comparator | Patients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration. Receives: Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Ixabepilone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20
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.
Measured: During the first 18 weeks of ixabepilone-based therapy
Secondary outcomes (8)
Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale
Measured: Up to 12 months from initiation of ixabepilone
Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version
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.
Measured: Up to 12 months from initiation of ixabepilone
Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy
Measured: Up to 12 months from initiation of ixabepilone
Average Cumulative Ixabepilone Dose
Measured: Up to 12 months from initiation of ixabepilone
Toxicity Profile of CaMg Per CTCAE Active Version
Measured: Up to 12 months from initiation of ixabepilone
Incidence of the Acute Pain Syndrome (APS)
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.
Measured: Treatment initiation to day 21 (Cycle 1)
Severity of the Acute Pain Syndrome (APS)
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.
Measured: Treatment initiation to day 21 (Cycle 1)
Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy
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.
Measured: First cycle of therapy (up to 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJan 2013
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Charles Loprinzi, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998738
- Sponsor's protocol ID
- RC08CC
- Other IDs
- NCI-2009-01229, RC08CC, P30CA015083
- Status last verified
- Nov 2015
- First submitted
- 19 Oct 2009
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Calcium and Magnesium for Prevention of Ixabepilone Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00998738
- Acronym / sponsor ID
- RC08CC
- Conditions
- Neuropathy, Pain, Recurrent Breast Carcinoma, Stage IV Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 29 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (calcium gluconate, magnesium sulfate) | Experimental | Drug: Calcium Gluconate, Drug: Magnesium Sulfate, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: IxabepilonePatients receive calcium gluconate and magnesium sulfate IV over 30 minutes immediately before and after each ixabepilone administration. |
| Arm II (placebo) | Placebo comparator | Other: Placebo, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: IxabepilonePatients receive placebo IV over 30 minutes immediately before and after each ixabepilone administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Scheduled to undergo cancer treatment for metastatic breast cancer (weekly or once every three weeks) with ixabepilone with no prior exposure to ixabepilone and no more than 2 prior chemotherapy regimens for metastatic disease
- Serum calcium =< 1.2 x upper normal limit (UNL)
- Serum magnesium =< UNL
- Serum creatinine =< 1.5 x UNL
- Ability to sign informed consent and understand the nature of a placebo-controlled trial
Key exclusion criteria (12 listed)
- Pre-existing history of peripheral neuropathy >= grade 2 (National Cancer Institute [NCI] CTCAE Active Version) due to any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.)
- Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc., or any other treatments specifically for prevention or treatment of neuropathy
- Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient
- Any of the following:
- Diagnosed diabetes requiring insulin or oral hypoglycemic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium GluconateAlso: Calcium D-gluconate, CalgluconGiven IV | Drug | Arm I (calcium gluconate, magnesium sulfate) |
| Magnesium SulfateAlso: Magnesium SO4, Magnesium Sulfate whiskersGiven IV | Drug | Arm I (calcium gluconate, magnesium sulfate) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven IV | Other | Arm II (placebo) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (calcium gluconate, magnesium sulfate), Arm II (placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (calcium gluconate, magnesium sulfate), Arm II (placebo) |
| IxabepiloneAlso: IXEMPRAGiven IV | Drug | Arm I (calcium gluconate, magnesium sulfate), Arm II (placebo) |
Primary outcome
Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20
Time frame: During the first 18 weeks of ixabepilone-based therapy
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.
8 secondary outcomes
Percentage of Patients With Grade 2+ and/or Grade 3+ Neurotoxicity as Measured by NCI CTCAE Active Version Neuropathy Scale
Time frame: Up to 12 months from initiation of ixabepilone
Time to Onset of Grade 2+ and/or Grade 3+ Neurotoxicity as Assessed by NCI CTCAE Active Version
Time frame: Up to 12 months from initiation of ixabepilone
Proportion of Patients Undergoing Dose Reduction or Discontinuing Ixabepilone Secondary to Peripheral Neuropathy
Time frame: Up to 12 months from initiation of ixabepilone
Average Cumulative Ixabepilone Dose
Time frame: Up to 12 months from initiation of ixabepilone
Toxicity Profile of CaMg Per CTCAE Active Version
Time frame: Up to 12 months from initiation of ixabepilone
Incidence of the Acute Pain Syndrome (APS)
Time frame: Treatment initiation to day 21 (Cycle 1)
Severity of the Acute Pain Syndrome (APS)
Time frame: Treatment initiation to day 21 (Cycle 1)
Association Between the Ixabepilone-APS and Eventual Chemotherapy-induced Neuropathy
Time frame: First cycle of therapy (up to 21 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Loprinzi principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium Gluconate, Magnesium Sulfate and Quality-of-Life Assessment in people with Neuropathy and Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Chemotherapy-induced Peripheral Neuropathy Between Calcium With Magnesium (CaMg) and Placebo Arms, as Measured by the Sensory Subscale of EORTC QLQ-CIPN20 (time frame: During the first 18 weeks of ixabepilone-based therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.