Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03146338 |
| Other study ID # |
ILC-2-2016 |
| Secondary ID |
2016-A01091-50 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 4, 2017 |
| Est. completion date |
January 4, 2023 |
Study information
| Verified date |
October 2021 |
| Source |
Weprom |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
