SMA II

Cerebral Palsy

The subjects will be treated with paracetamol in therapeutic doses, 15mg/kg/dose every six hour, with a maximum dosage of 1 g x 4 per day, for three consecutive days.

Paracetamol 120Mg/5mL Oral Suspension

Copenhagen Neuromuscular Center

Paracetamol Study in Patients With Low Muscle Mass

Pharmacokinetics and Safety of Treatment With Paracetamol in Children and Adults With Spinal Muscular Atrophy and Cerebral Palsy

- Clearance (total, glucuronidation, sulphation, CYP2E1 oxidation and unchanged) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

- Clearance (total paracetamol) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

- Clearance (glucuronidation) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

- Clearance (sulphation) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

- Clearance (CYP2E1 oxidation) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

- Clearance (unchanged paracetamol) of paracetamol in patients with SMA, CP and ICU-admitted patients with either SMA or CP

- Volume of distribution of paracetamol in patients with SMA, CP and ICU-admitted patients with SMA or CP, in comparison with healthy controls.

- Liver function tests in patients with SMA, CP and ICU-admitted patients with SMA or CP.: ALT, AST, LDH, Alkaline Phosphatase, Bilirubin (U/L)

- Concentration-time data on plasma paracetamol, paracetamol-sulphate, paracetamol-glucuronide, paracetamol-cysteine and paracetamol-mercapturate (oxidative metabolites), plasma-glutathione and liver biomarkers (ALAT, PP, bilirubin, MicroRNA-122 (miR-122)).

Mette Cathrine Oerngreen

Principal Investigator

Elsass Foundation

Watercress will be tested in its natural form as a food item that will supplement the usual diet, via the prescription of watercress as whole food added daily to the usual diet. The intervention group will be asked to consume 100 grams of watercress per day, in addition to their usual diet for the total time of RT treatment. These 100 grams of watercress per day will allow the achievement of the daily "therapeutic" dose.

The control group will receive the standard of care, thus will maintain their ad libitum diet.

Long-term Effects Secondary to Cancer Therapy in Adults

100g of watercress daily during radiation therapy

Watercress

Hospital de Santa Maria

Does Watercress Intake Have an Impact on Cancer Patients Outcomes: a Longitudinal Trial

Does Watercress Intake Have an Impact on Cancer Patients Outcomes: a Randomized Longitudinal Trial

as an indirect measure of cell membrane integrity, function and metabolism

assessed by tetrapolar multifrequency Bioimpedance Analysis (BIA) and CT scan images; CT scans analysis will be performed in collaboration with expert groups

Assessed by the RTOG Common Toxicity Criteria, developed by the Eastern Cooperative Oncology Group (RTOG)

Evaluated by a radiation oncologist, using a validated toxicity scale

will be assessed by the European Organisation for Research and Treatment of Cancer (EORTC-QLQ C30), validated for Oncology

DNA damage assessment by Comet assay in lymphocytes has been used extensively as a surrogate biomarker to measure exposure to genotoxic agents and assess cancer risk in human studies by us and others. biological samples will comprise serum or plasma (1 mL) prepared from blood samples collected in Heparin tubes and urine (1 mL). Metabolomic profiles will be measured on a 700 MHz 1H NMR spectrometer equipped with a cryo-probe for enhanced sensitivity. 1H NMR spectroscopy: high throughput metabolic phenotyping is a powerful approach for characterising biochemical signatures of biological samples. We will couple high-resolution 1H NMR spectroscopy and mathematical modelling approaches to determine the metabolic profile in biological samples from patients.

Metabolomics simultaneously measures thousands of low molecular weight metabolites providing holistic information on the biochemical status of the body. Previous metabolomic studies have identified cancer-associated perturbations in the metabolic phenotypes of patients. This study will explore the ability of watercress to improve the restorative effects of radiotherapy in breast cancer patients on the metabolic status towards a healthy phenotype

assessed by the method Patient-Generated Subjective Global Assessment, specific and validated for Oncology

Will derive from a diet history and a 24-hour-recall food questionnaire. The software Dietplan6 (Forestfield Software Ltd 2013®, Horsham, UK) will analyze the nutrient content of foods consumed

The plasma samples analysis will also include the measurement of carotenoids and flavonoids, which are present in watercress, and are related with antigenotoxic effects in vitro and have anti-proliferative effects, as demonstrated in several studies. Urine samples analysis will allow the measurement of flavonoids.

quinone/hypoxia

Paracetamol Study in Patients With Low Muscle Mass

Does Watercress Intake Have an Impact on Cancer Patients Outcomes: a Longitudinal Trial

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