An interventional study of Magnesium-rich mineral water (Rozana) in Metastatic Colorectal Cancer and Metastatic Head and Neck Cancer, sponsored by Weprom. Status unknown at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-15.
Sponsored by Weprom · Not applicable, Interventional, and Prevention
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 106 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
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Patient having either:
Exclusion Criteria:
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.
Other: Magnesium-rich mineral water (Rozana)
Patients will have the usual care (oral advice only according to the habits of the investigator)
intakes of 1.5 L by day
Rate of patients with hypomagnesemia
Determination of the blood magnesium level at each cycle
Time frame: 3 months
Median rate of magnesium and hypomagnesemia grade III / IV
Determination of the blood magnesium level at each cycle
Time frame: 6 months
Proportion of patients with a 20% decrease in magnesemia
Determination of the blood magnesium level at each cycle
Time frame: 6 months
Incidence of hypomagnesemia after 2 cycles of anti-EGFR treatment
Determination of the blood magnesium level at each cycle
Time frame: 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
Time frame: 6 months
Rate of patient requiring magnesium supplementation
Number of patient requiring magnesium supplementation (oral or IV)
Time frame: 6 months
Rate of hypomagnesemia at 5 months of treatment
Determination of the blood magnesium level at each cycle
Time frame: 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
Time frame: 6 months
Quality of life
Completion of a quality of life questionnaire (QLQ-C30) at baseline and then at each even cycle
Time frame: 6 months
Compliance
Completion of a patient notebook allowing daily monitoring of the quantity and type of water consumed
Time frame: 6 months
Rate of diarrhea and cramps
Collection of adverse events classified according to NCI CTCAE V4.02
Time frame: 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
Time frame: 6 months
Time until hypomagnesemia occurrence, regardless of grade, and time until grade III / IV hypomagnesemia
Time between treatment initiation and occurrence of hypomagnesemia
Time frame: 6 months
Progression-free survival
Time between treatment initiation and cancer progression
Time frame: 2 years
Overall survival
Time between treatment initiation and the patient's death within 2 years after treatment initiation
Time frame: 2 years
Plan to share: No
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