Metastatic Colorectal CancerOPTIMAGNCT03146338
Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR (OPTIMAG)
A study testing Magnesium-rich mineral water (Rozana) in people with Metastatic Colorectal Cancer and Metastatic Head and Neck Cancer, run by Weprom at 12 sites in France.
Trial summary
Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Metastatic Head and Neck Cancer
- What is being tested?
- Magnesium-rich mineral water (Rozana)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 12 sitesFrance
- Study dates
- 4 Jul 2017to 4 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient having either:
- a metastatic head and neck cancer or in locoregional relapse, proved histologically, authorizing an oral feeding or by gastrostomy or nasogastric tube,
- a metastatic colorectal cancer, histologically proved, wild-type RAS
- Patient who must be treated by anti-EGFR for this cancer
- Age ≥ 18 years
- Performance Status = 0, 1 or 2
- Patient affiliated to a social security scheme
- Patient who have given written consent prior to any specific study-related procedure
Who cannot join
- Cerebral metastasis
- Previous anti-EGFR treatment
- Patient requiring exclusive parenteral nutrition and hydration
- Concomitant treatment by radiotherapy
- Presence of another invasive cancer, other than head and neck or digestive, except basal cell carcinoma or intracervical neoplasia treated
- Presence of hypomagnesemia at randomization
Show all 15Show fewer
- Ongoing oral or intravenous magnesium supplementation within 2 weeks before randomization
- Patient with grade III or IV diarrhea within 2 weeks before randomization
- Patient who have had a jejunostomy or ileostomy
- Patient with constitutional tubulopathy
- Patient with chronic renal insufficiency (MDRD Clarity <60 mL / min)
- Pregnancy or breast-feeding
- Persons deprived of their liberty or under guardianship
- Dementia, mental impairment or psychiatric pathology that may compromise the patient's informed consent and / or adherence to the protocol and follow-up of the trial
- Patient who can not follow protocol for psychological, social, family or geographical reasons
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Centre Maurice TUBIANA
Caen, Normandy, 14000
CORT 37
Chambray-lès-Tours, 37175
Centre Hospitalier Départemental
La Roche-sur-Yon
Centre Hospitalier
Le Mans, 72000
Centre Jean Bernard
Le Mans, 72000
GHBS Lorient
Lorient, Brittany Region, 56100
Polyclinique de Gentilly
Nancy, 54100
Centre Hospitalier
Niort, 79000
CARIO-HPCA Plérin
Plérin, Brittany Region, 22190
Centre Hospitalier Centre Bretagne
Pontivy
CHRU Tours
Tours, 37044
Centre d'Oncolgie Saint Yves
Vannes
About this study
Official title: Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR Monoclonal Antibody
Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often neglected and under-treated.
Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is often underestimated because they are difficult to identify and accountable by clinicians in the context of cancer under chemotherapy.
Read more
There is currently no national or international recommendation on the management of hypomagnesaemia in oncology and medicine in general. There are, however, on the market many nutritional supplements rich in magnesium in the form of tablets or oral solution, in multiple dosages.
These food supplements rich in magnesium are sold without proof of effectiveness. Moreover, the prescription of oral magnesium supplementation adds to the oncology patient an over-medicalization, which can be poorly tolerated at the digestive level, and responsible for diarrhea and a lack of compliance.
The European Food Safety Authority (EFSA) recommends in its opinion on "Dietary reference values for water" to consume 2 liters for women and 2.5 liters for men every day, all sources combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5 Liter per day excluding food. However, there are multiple water marketed or distributed freely, with different compositions. Thus the quantity and quality of the mineral water consumed can influence the metabolism. Rozana® mineral water, has the double advantage of being the French water the most concentrated in magnesium (160 mg / L) and of being lowly concentrated in sulphate, responsible of the laxative power of certain waters.
Instead of adding magnesium supplements with a poor digestive tolerance, to patients with metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate whether a change in oral hydration in quantitative and qualitative terms can decrease the rate of hypomagnesemia in patients treated with anti-EGFR.
Read the detailed description
Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often neglected and under-treated.
Magnesium remains the fourth cation and the second most important intracellular cation in the body. It is an indispensable cofactor in multiple enzymatic reactions. Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is often underestimated because they are difficult to identify and accountable by clinicians in the context of cancer under chemotherapy.
There is currently no national or international recommendation on the management of hypomagnesaemia in oncology and medicine in general. Hypomagnesemia is, in daily practice, mostly undiagnosed or untreated. There are, however, on the market many nutritional supplements rich in magnesium in the form of tablets or oral solution, in multiple dosages.
To date, these food supplements rich in magnesium are sold without proof of effectiveness. The clinical data are very insufficient, and no oral supplementation is reimbursed. Moreover, the prescription of oral magnesium supplementation, often several intakes a day, adds to the oncology patient an over-medicalization, which can be poorly tolerated at the digestive level, and responsible for diarrhea and a lack of compliance. Oral hydration is one of the most prescribed medical advice and remains essential to combat the risk of dehydration in extreme ages. The European Food Safety Authority (EFSA) recommends in its opinion on "Dietary reference values for water" to consume 2 liters for women and 2.5 liters for men every day, all sources combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5 Liter per day excluding food. However, there are multiple water marketed or distributed freely, with different compositions. Thus the quantity and quality of the mineral water consumed can influence the metabolism.
The digestive absorption of magnesium provided by mineral water in a healthy individual was evaluated at around 40 to 50%. Rozana® mineral water, has the double advantage of being the French water the most concentrated in magnesium (160 mg / L) and of being lowly concentrated in sulphate, responsible of the laxative power of certain waters.
Instead of adding magnesium supplements with a poor digestive tolerance, to patients with metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate whether a change in oral hydration in quantitative and qualitative terms can decrease the rate of hypomagnesemia in patients treated with anti-EGFR.
- Being tested
- Magnesium-rich mineral water (Rozana)
- Keywords
- Anti-EGFR, Hypomagnesemia, Magnesium-rich mineral water, Metastatic colorectal or head and neck cancers
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium-rich mineral water (Rozana)Other
intakes of 1.5 L by day
| Study group | Role | What they receive |
|---|---|---|
| Magnesium-rich mineral water (Rozana) | Experimental | Patients in this arm must take 1.5 Liter by day of a mineral water rich in magnesium (Rozana) during the treatment by anti-EGFR. The mineral water is provided. Receives: Other: Magnesium-rich mineral water (Rozana) |
| Standard | No intervention | Patients will have the usual care (oral advice only according to the habits of the investigator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with hypomagnesemia
Determination of the blood magnesium level at each cycle
Measured: 3 months
Secondary outcomes (14)
Median rate of magnesium and hypomagnesemia grade III / IV
Determination of the blood magnesium level at each cycle
Measured: 6 months
Proportion of patients with a 20% decrease in magnesemia
Determination of the blood magnesium level at each cycle
Measured: 6 months
Incidence of hypomagnesemia after 2 cycles of anti-EGFR treatment
Determination of the blood magnesium level at each cycle
Measured: 6 months
The fraction of urinary excretion over 24 hours of magnesium
Determination of urinary magnesium at the inclusion then at each even cycle of chemotherapy
Measured: 6 months
Rate of patient requiring magnesium supplementation
Number of patient requiring magnesium supplementation (oral or IV)
Measured: 6 months
Rate of hypomagnesemia at 5 months of treatment
Determination of the blood magnesium level at each cycle
Measured: 5 months
Enteral intakes in magnesium
Completion of a feeding questionnaire at baseline and then at each even cycle. Completion of a patient notebook allowing daily monitoring of the quantity and type of water consumed Collection of concomitant treatment by magnesium
Measured: 6 months
Quality of life
Completion of a quality of life questionnaire (QLQ-C30) at baseline and then at each even cycle
Measured: 6 months
Compliance
Completion of a patient notebook allowing daily monitoring of the quantity and type of water consumed
Measured: 6 months
Rate of diarrhea and cramps
Collection of adverse events classified according to NCI CTCAE V4.02
Measured: 6 months
Hypocalcaemia and hypokalemia rates
Determination of blood calcium and potassium levels at the time of inclusion and then at each cycle of chemotherapy
Measured: 6 months
Time until hypomagnesemia occurrence, regardless of grade, and time until grade III / IV hypomagnesemia
Time between treatment initiation and occurrence of hypomagnesemia
Measured: 6 months
Progression-free survival
Time between treatment initiation and cancer progression
Measured: 2 years
Overall survival
Time between treatment initiation and the patient's death within 2 years after treatment initiation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start4 Jul 2017
- Primary completion4 May 2021
- Study completion4 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- Neptune
- Responsible party
- Sponsor
- Investigators
- Hugues BOURGEOIS, MD, Principal investigator, Centre Jean Bernard - Le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146338
- Sponsor's protocol ID
- ILC-2-2016
- Other IDs
- 2016-A01091-50
- Acronym
- OPTIMAG
- Status last verified
- Oct 2021
- First submitted
- 5 May 2017
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR Monoclonal Antibody
- ClinicalTrials.gov ID
- NCT03146338
- Acronym / sponsor ID
- OPTIMAG / ILC-2-2016
- Keywords
- Anti-EGFR, Hypomagnesemia, Magnesium-rich mineral water, Metastatic colorectal or head and neck cancers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- Neptune
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 Jan 2023 (estimated)
- First posted
- 9 May 2017 (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.
Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often neglected and under-treated.
Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is often underestimated because they are difficult to identify and accountable by clinicians in the context of cancer under chemotherapy.
There is currently no national or international recommendation on the management of hypomagnesaemia in oncology and medicine in general. There are, however, on the market many nutritional supplements rich in magnesium in the form of tablets or oral solution, in multiple dosages.
These food supplements rich in magnesium are sold without proof of effectiveness. Moreover, the prescription of oral magnesium supplementation adds to the oncology patient an over-medicalization, which can be poorly tolerated at the digestive level, and responsible for diarrhea and a lack of compliance.
The European Food Safety Authority (EFSA) recommends in its opinion on "Dietary reference values for water" to consume 2 liters for women and 2.5 liters for men every day, all sources combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5 Liter per day excluding food. However, there are multiple water marketed or distributed freely, with different compositions. Thus the quantity and quality of the mineral water consumed can influence the metabolism. Rozana® mineral water, has the double advantage of being the French water the most concentrated in magnesium (160 mg / L) and of being lowly concentrated in sulphate, responsible of the laxative power of certain waters.
Instead of adding magnesium supplements with a poor digestive tolerance, to patients with metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate whether a change in oral hydration in quantitative and qualitative terms can decrease the rate of hypomagnesemia in patients treated with anti-EGFR.
Detailed description
Anti-EGFR (Epidermal Growth Factor Receptor) therapies, namely cetuximab and panitumumab, have become standards in the management of metastatic colorectal and head and neck cancers. These therapies are used in daily practice, that requiring to manage their skin and digestive toxicities. However, anti-EGFR are also frequently responsible for hypomagnesemia often neglected and under-treated.
Magnesium remains the fourth cation and the second most important intracellular cation in the body. It is an indispensable cofactor in multiple enzymatic reactions. Hypomagnesemia may manifest as asthenia, cramps, muscle weakness, mood disorders. She is often underestimated because they are difficult to identify and accountable by clinicians in the context of cancer under chemotherapy.
There is currently no national or international recommendation on the management of hypomagnesaemia in oncology and medicine in general. Hypomagnesemia is, in daily practice, mostly undiagnosed or untreated. There are, however, on the market many nutritional supplements rich in magnesium in the form of tablets or oral solution, in multiple dosages.
To date, these food supplements rich in magnesium are sold without proof of effectiveness. The clinical data are very insufficient, and no oral supplementation is reimbursed. Moreover, the prescription of oral magnesium supplementation, often several intakes a day, adds to the oncology patient an over-medicalization, which can be poorly tolerated at the digestive level, and responsible for diarrhea and a lack of compliance. Oral hydration is one of the most prescribed medical advice and remains essential to combat the risk of dehydration in extreme ages. The European Food Safety Authority (EFSA) recommends in its opinion on "Dietary reference values for water" to consume 2 liters for women and 2.5 liters for men every day, all sources combined (food and beverages). The drink represent 80% of the water intake, that is about 1.5 Liter per day excluding food. However, there are multiple water marketed or distributed freely, with different compositions. Thus the quantity and quality of the mineral water consumed can influence the metabolism.
The digestive absorption of magnesium provided by mineral water in a healthy individual was evaluated at around 40 to 50%. Rozana® mineral water, has the double advantage of being the French water the most concentrated in magnesium (160 mg / L) and of being lowly concentrated in sulphate, responsible of the laxative power of certain waters.
Instead of adding magnesium supplements with a poor digestive tolerance, to patients with metastatic cancer and often with a heavy treatment , the aim of this study is to evaluate whether a change in oral hydration in quantitative and qualitative terms can decrease the rate of hypomagnesemia in patients treated with anti-EGFR.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium-rich mineral water (Rozana) | Experimental | Other: Magnesium-rich mineral water (Rozana)Patients in this arm must take 1.5 Liter by day of a mineral water rich in magnesium (Rozana) during the treatment by anti-EGFR. The mineral water is provided. |
| Standard | No intervention | –Patients will have the usual care (oral advice only according to the habits of the investigator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient having either:
- Patient who must be treated by anti-EGFR for this cancer
- Age ≥ 18 years
- Performance Status = 0, 1 or 2
- Patient affiliated to a social security scheme
Key exclusion criteria (15 listed)
- Cerebral metastasis
- Previous anti-EGFR treatment
- Patient requiring exclusive parenteral nutrition and hydration
- Concomitant treatment by radiotherapy
- Presence of another invasive cancer, other than head and neck or digestive, except basal cell carcinoma or intracervical neoplasia treated
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 |
|---|---|---|
| Magnesium-rich mineral water (Rozana)intakes of 1.5 L by day | Other | Magnesium-rich mineral water (Rozana) |
Primary outcome
Rate of patients with hypomagnesemia
Time frame: 3 months
Determination of the blood magnesium level at each cycle
14 secondary outcomes
Median rate of magnesium and hypomagnesemia grade III / IV
Time frame: 6 months
Proportion of patients with a 20% decrease in magnesemia
Time frame: 6 months
Incidence of hypomagnesemia after 2 cycles of anti-EGFR treatment
Time frame: 6 months
The fraction of urinary excretion over 24 hours of magnesium
Time frame: 6 months
Rate of patient requiring magnesium supplementation
Time frame: 6 months
Rate of hypomagnesemia at 5 months of treatment
Time frame: 5 months
Enteral intakes in magnesium
Time frame: 6 months
Quality of life
Time frame: 6 months
Compliance
Time frame: 6 months
Rate of diarrhea and cramps
Time frame: 6 months
Hypocalcaemia and hypokalemia rates
Time frame: 6 months
Time until hypomagnesemia occurrence, regardless of grade, and time until grade III / IV hypomagnesemia
Time frame: 6 months
Progression-free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Hugues BOURGEOIS, MD principal investigator
Centre Jean Bernard - Le Mans
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium-rich mineral water (Rozana) in people with Metastatic Colorectal Cancer and Metastatic Head and Neck Cancer, run by Weprom at 12 sites in France.
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 8 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
Results are not available in the source record.
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?
Rate of patients with hypomagnesemia (time frame: 3 months). 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 15 Oct 2021.