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

NCT03146338 | Unknown

• 2 other identifiers: ILC-2-20162016-A01091-50
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 12

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.

Conditions

Metastatic Colorectal Cancer; Metastatic Head and Neck Cancer

Keywords

Anti-EGFR; Hypomagnesemia; Magnesium-rich mineral water; Metastatic colorectal or head and neck cancers

Outcome Measures

Primary Outcomes (1)

• Rate of patients with hypomagnesemia

  Determination of the blood magnesium level at each cycle

  3 months

Secondary Outcomes (14)

• Median rate of magnesium and hypomagnesemia grade III / IV

  6 months

• Proportion of patients with a 20% decrease in magnesemia

  6 months

• Incidence of hypomagnesemia after 2 cycles of anti-EGFR treatment

  6 months

• The fraction of urinary excretion over 24 hours of magnesium

  6 months

• Rate of patient requiring magnesium supplementation

  6 months

Study Arms (2)

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.

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)

Interventions

Magnesium-rich mineral water (Rozana) OTHER

intakes of 1.5 L by day

Magnesium-rich mineral water (Rozana)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Weprom: lead
• Neptune: collaborator

Study Sites (12)

GHBS Lorient

Lorient, Brittany Region, 56100, France

Location

CARIO-HPCA Plérin

Plérin, Brittany Region, 22190, France

Location

Centre Maurice TUBIANA

Caen, Normandy, 14000, France

Location

CORT 37

Chambray-lès-Tours, 37175, France

Location

Centre Hospitalier Départemental

La Roche-sur-Yon, France

Location

Centre Hospitalier

Le Mans, 72000, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Polyclinique de Gentilly

Nancy, 54100, France

Location

Centre Hospitalier

Niort, 79000, France

Location

Centre Hospitalier Centre Bretagne

Pontivy, France

Location

CHRU Tours

Tours, 37044, France

Location

Centre d'Oncolgie Saint Yves

Vannes, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hugues BOURGEOIS, MD

  Centre Jean Bernard - Le Mans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: July 4, 2017
• Primary Completion: May 4, 2021
• Study Completion: January 4, 2023
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)