Ovarian Carcinoma
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DIETARY_SUPPLEMENTDietary Intervention
Receive dietary magnesium intervention
OTHERMedia Intervention
Undergo video interviews
BEHAVIORALTelephone-Based Intervention
Receive phone calls
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with previously untreated ovarian cancer. * Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles. * Able to tolerate an oral diet.
Exclusion criteria
* Prior platinum-based chemotherapy. * Serum creatinine level \> 1.4 mg/dL prior to treatment. * Artificial nutrition (e.g. Ensure or Boost) accounts for \> 50% of total calorie intake.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient retention rate | Up to 2 years | 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. |
| Dietary adherence rate | Up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of hypomagnesemia | Up to 2 years | Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed. |
| Need for a pharmacy intervention including oral and intravenous magnesium dosage | Up to 2 years | Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLorenzo Cohen, PHD
M.D. Anderson Cancer Center
Outcome results
None listed