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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02450 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-1172 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well a diet high in magnesium works in preventing low blood magnesium levels (hypomagnesemia) in patients with ovarian cancer receiving carboplatin chemotherapy. Hypomagnesemia is a common side effect of carboplatin-containing chemotherapy. A magnesium rich diet may increase the levels of magnesium in the blood and help prevent hypomagnesemia resulting from carboplatin chemotherapy.
PRIMARY OBJECTIVE:
I. Evaluate intervention feasibility.
SECONDARY OBJECTIVE:
I. Evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage.
EXPLORATORY OBJECTIVE:
I. Explore changes in other electrolytes, weight, and occurrence of chemotherapy delay or discontinuation and hospitalization which can be related to dietary intervention and program completion.
OUTLINE:
Patients receive a dietary magnesium intervention consisting of a food reference list and phone calls or video interviews from a registered dietitian, integrative medicine physician, or a mid-level provider over 10-20 minutes once a week for up to the 6th cycle of chemotherapy (average 15 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (dietary intervention) | Experimental | Patients receive a dietary magnesium intervention consisting of a food reference list and phone calls or video interviews from a registered dietitian, integrative medicine physician, or a mid-level provider over 10-20 minutes once a week for up to the 6th cycle of chemotherapy (average 15 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Intervention | Dietary Supplement | Receive dietary magnesium intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient retention rate | Assessed by percentage of patients completing the dietary intervention. If a patient participated 60% or more of the weekly follow up by the end of the 6th cycle of treatment, she is considered retained. Descriptive statistics (e.g., frequencies, proportions, means, standard deviations [SDs], and ranges), along with 95% confidence intervals (CIs) for the means, will be computed. | Up to 2 years |
| Dietary adherence rate | Ratio of actual dietary magnesium intake versus the desired 400 mg. Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of hypomagnesemia | Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed. | Up to 2 years |
| Need for a pharmacy intervention including oral and intravenous magnesium dosage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Cohen, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2022 | Oct 7, 2024 |
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| Media Intervention | Other | Undergo video interviews |
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| Telephone-Based Intervention | Behavioral | Receive phone calls |
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Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed. |
| Up to 2 years |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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