Ovarian CarcinomaNCT04310826
Dietary Magnesium in Preventing Low Blood Magnesium Levels in Patients With Ovarian Cancer Receiving Carboplatin Chemotherapy
A study testing Dietary Intervention, Media Intervention and Telephone-Based Intervention in people with Ovarian Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Carcinoma
- What is being tested?
- Dietary Intervention, Media Intervention and Telephone-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with previously untreated ovarian cancer.
- Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.
- Able to tolerate an oral diet.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Dietary Magnesium Replacement for Prevention of Hypomagnesemia in Ovarian Cancer Patients Receiving Carboplatin Chemotherapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate intervention feasibility.
SECONDARY OBJECTIVE:
- Evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage.
EXPLORATORY OBJECTIVE:
- 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).
- Conditions
- Ovarian Carcinoma
- Being tested
- Dietary Intervention, Media Intervention, Telephone-Based Intervention
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionDietary supplement
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive dietary magnesium intervention
Media InterventionOther
Undergo video interviews
Telephone-Based InterventionBehavioural
Receive phone calls
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Dietary Intervention; Other: Media Intervention; Behavioral: Telephone-Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (2)
Occurrence of hypomagnesemia
Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed.
Measured: Up to 2 years
Need for a pharmacy intervention including oral and intravenous magnesium dosage
Descriptive statistics (e.g., frequencies, proportions, means, SDs, and ranges), along with 95% CIs for the means, will be computed.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start23 Apr 2019
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Cohen, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310826
- Sponsor's protocol ID
- 2018-1172
- Other IDs
- NCI-2019-02450, 2018-1172
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Dietary Magnesium Replacement for Prevention of Hypomagnesemia in Ovarian Cancer Patients Receiving Carboplatin Chemotherapy
- ClinicalTrials.gov ID
- NCT04310826
- Acronym / sponsor ID
- 2018-1172
- Conditions
- Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate intervention feasibility.
SECONDARY OBJECTIVE:
- Evaluate occurrence of hypomagnesemia and the need for a pharmacy regimen including oral and intravenous magnesium dosage.
EXPLORATORY OBJECTIVE:
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (dietary intervention) | Experimental | Dietary Supplement: Dietary Intervention, Other: Media Intervention, Behavioral: Telephone-Based InterventionPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with previously untreated ovarian cancer.
- Receiving carboplatin-containing chemotherapy of at least 6 consecutive cycles.
- Able to tolerate an oral diet.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive dietary magnesium intervention | Dietary supplement | Prevention (dietary intervention) |
| Media InterventionUndergo video interviews | Other | Prevention (dietary intervention) |
| Telephone-Based InterventionReceive phone calls | Behavioural | Prevention (dietary intervention) |
Primary outcome
Patient retention rate
Time frame: 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
Time frame: 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.
2 secondary outcomes
Occurrence of hypomagnesemia
Time frame: Up to 2 years
Need for a pharmacy intervention including oral and intravenous magnesium dosage
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Lorenzo Cohen, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention, Media Intervention and Telephone-Based Intervention in people with Ovarian Carcinoma, run by M.D. Anderson Cancer Center 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Patient retention rate (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 21 Aug 2026.