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Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR (OPTIMAG) (OPTIMAG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03146338
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
Neptune
Information provided by (Responsible Party):
Weprom

Brief 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.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Metastatic Head and Neck Cancer Other: Magnesium-rich mineral water (Rozana) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylaxis of Magnesium-rich Mineral Water to Prevent Hypomagnesemia Induced by an Anti-EGFR Monoclonal Antibody
Actual Study Start Date : July 4, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

Arm Intervention/treatment
Experimental: 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.
Other: Magnesium-rich mineral water (Rozana)
intakes of 1.5 L by day

No Intervention: Standard
Patients will have the usual care (oral advice only according to the habits of the investigator)



Primary Outcome Measures :
  1. Rate of patients with hypomagnesemia [ Time Frame: 3 months ]
    Determination of the blood magnesium level at each cycle


Secondary Outcome Measures :
  1. Median rate of magnesium and hypomagnesemia grade III / IV [ Time Frame: 6 months ]
    Determination of the blood magnesium level at each cycle

  2. Proportion of patients with a 20% decrease in magnesemia [ Time Frame: 6 months ]
    Determination of the blood magnesium level at each cycle

  3. Incidence of hypomagnesemia after 2 cycles of anti-EGFR treatment [ Time Frame: 6 months ]
    Determination of the blood magnesium level at each cycle

  4. The fraction of urinary excretion over 24 hours of magnesium [ Time Frame: 6 months ]
    Determination of urinary magnesium at the inclusion then at each even cycle of chemotherapy

  5. Rate of patient requiring magnesium supplementation [ Time Frame: 6 months ]
    Number of patient requiring magnesium supplementation (oral or IV)

  6. Rate of hypomagnesemia at 5 months of treatment [ Time Frame: 5 months ]
    Determination of the blood magnesium level at each cycle

  7. Enteral intakes in magnesium [ Time Frame: 6 months ]
    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

  8. Quality of life [ Time Frame: 6 months ]
    Completion of a quality of life questionnaire (QLQ-C30) at baseline and then at each even cycle

  9. Compliance [ Time Frame: 6 months ]
    Completion of a patient notebook allowing daily monitoring of the quantity and type of water consumed

  10. Rate of diarrhea and cramps [ Time Frame: 6 months ]
    Collection of adverse events classified according to NCI CTCAE V4.02

  11. Hypocalcaemia and hypokalemia rates [ Time Frame: 6 months ]
    Determination of blood calcium and potassium levels at the time of inclusion and then at each cycle of chemotherapy

  12. Time until hypomagnesemia occurrence, regardless of grade, and time until grade III / IV hypomagnesemia [ Time Frame: 6 months ]
    Time between treatment initiation and occurrence of hypomagnesemia

  13. Progression-free survival [ Time Frame: 2 years ]
    Time between treatment initiation and cancer progression

  14. Overall survival [ Time Frame: 2 years ]
    Time between treatment initiation and the patient's death within 2 years after treatment initiation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Patient who must be treated by anti-EGFR for this cancer
  3. Age ≥ 18 years
  4. Performance Status = 0, 1 or 2
  5. Patient affiliated to a social security scheme
  6. Patient who have given written consent prior to any specific study-related procedure

Exclusion Criteria:

  1. Cerebral metastasis
  2. Previous anti-EGFR treatment
  3. Patient requiring exclusive parenteral nutrition and hydration
  4. Concomitant treatment by radiotherapy
  5. Presence of another invasive cancer, other than head and neck or digestive, except basal cell carcinoma or intracervical neoplasia treated
  6. Presence of hypomagnesemia at randomization
  7. Ongoing oral or intravenous magnesium supplementation within 2 weeks before randomization
  8. Patient with grade III or IV diarrhea within 2 weeks before randomization
  9. Patient who have had a jejunostomy or ileostomy
  10. Patient with constitutional tubulopathy
  11. Patient with chronic renal insufficiency (MDRD Clarity <60 mL / min)
  12. Pregnancy or breast-feeding
  13. Persons deprived of their liberty or under guardianship
  14. 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
  15. Patient who can not follow protocol for psychological, social, family or geographical reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146338


Contacts
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Contact: Magali BALAVOINE +33 2 41 68 29 40 m.balavoine@weprom.fr

Locations
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France
GHBS Lorient Active, not recruiting
Lorient, Bretagne, France, 56100
CARIO-HPCA Plérin Recruiting
Plérin, Bretagne, France, 22190
Contact: MARTIN BABAU Jérôme, MD         
Contact: VINCENT Aude         
Principal Investigator: MARTIN BABAU Jérôme, MD         
Centre Maurice TUBIANA Recruiting
Caen, Normandie, France, 14000
Contact: SEVIN Emmanuel, MD         
Contact: MEZERGUES Aline         
Principal Investigator: SEVIN Emmanuel, MD         
CORT 37 Recruiting
Chambray-lès-Tours, France, 37175
Contact: COMBE Pierre, MD         
Contact: JOUSSET Natacha, MD         
Principal Investigator: COMBE Pierre, MD         
Centre Hospitalier Départemental Recruiting
La Roche-sur-Yon, France
Contact: Jean-François RAMEE, MD       jean-francois.ramee@chd-vendee.fr   
Principal Investigator: Jean-François RAMEE, MD         
Centre Hospitalier Recruiting
Le Mans, France, 72000
Contact: Oana COJOCARASU, MD       ocojocarasu@ch-lemans.fr   
Principal Investigator: Oana COJOCARASU, MD         
Centre Jean Bernard Recruiting
Le Mans, France, 72000
Contact: Hugues BOURGEOIS, MD       h.bourgeois@cjb72.org   
Principal Investigator: Hugues BOURGEOIS, MD         
Polyclinique de Gentilly Active, not recruiting
Nancy, France, 54100
Centre Hospitalier Recruiting
Niort, France, 79000
Contact: Albert ALEBA, MD       albert.aleba@ch-niort.fr   
Principal Investigator: Albert ALEBA, MD         
Centre Hospitalier Centre Bretagne Recruiting
Pontivy, France
Contact: Emmanuel BLOT, MD       emmanuel.blot@ch-bretagne-atlantique.fr   
Principal Investigator: Emmanuel BLOT, MD         
CHRU Tours Active, not recruiting
Tours, France, 37044
Centre d'Oncolgie Saint Yves Recruiting
Vannes, France
Contact: Emmanuel BLOT, MD       eblot@centre-st-yves.fr   
Principal Investigator: Emmanuel BLOT, MD         
Sponsors and Collaborators
Weprom
Neptune
Investigators
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Principal Investigator: Hugues BOURGEOIS, MD Centre Jean Bernard - Le Mans

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Responsible Party: Weprom
ClinicalTrials.gov Identifier: NCT03146338    
Other Study ID Numbers: ILC-2-2016
2016-A01091-50 ( Other Identifier: French Health Products Safety Agency )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weprom:
Anti-EGFR
Hypomagnesemia
Magnesium-rich mineral water
Metastatic colorectal or head and neck cancers
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms