Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

2.7 g EPA supplementation in a 15 cc emulsion stick-pack

Placebo supplementation in a 15 cc emulsion stick-pack

EPA supplementation

Placebo

Lorena Arribas, RD, MsC

Evaluates the effect of EPA supplementation in terms of muscle mass in patients with squamous cell carcinoma of the head and neck locally advanced

This study is designed to evaluate the effect of EPA supplementation on muscle mass in patients with squamous cell carcinoma of the head and neck locally advanced (stage III-IVb) to assess that supplementation with EPA can maintain muscle mass along the oncologic treatment. Other aims are to evaluate the nutritional status, acute and chronic toxicities related with the loss of muscle mass and the impact of the EPA supplementation on overall and disease-free survival.

eicosapentanoic acid (EPA) versus placebo

Changes in Body Composition After EPA Supplementation in Head and Neck Patients

Relationship Between Changes in Body Composition and Supplementation With EPA in Patients Diagnosed With Squamous Cell Carcinoma of Head and Neck Locally Advanced (Stage III-IVb)

To evaluate the effect of supplementation with EPA on muscle mass during a conservative non-surgical treatment of organ in patients with squamous cell carcinoma of head and neck locally advanced.

To evaluate on muscle mass using imaging such as CT scan

To assess the evolution of nutritional status using PG-VGS (patient generated subjective global assessment)

To evaluate the frequency of acute toxicity using the CTCAE v4 criteria

To evaluate the frequency of chronic toxicity using the CTCAE v4 criteria

To evaluate whether the effect of supplementation with EPA influences the loco-regional control using a CT scan

o To evaluate and compare the effect of supplementation with EPA on the perceptions of patients through quality of life questionnaires (QLQ) validated such as QLA-C30

To assess adherence to EPA using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment of the EPA concentration in the erythrocyte membrane

To evaluate the functional status using hand grip

To compare the need for nutritional support and nutritional intervention required using data collection sheet with the different types of nutritional support, days of each nutritional intervention and adherence to it.

To evaluate whether the effect of supplementation with EPA influences the recurrence-free survival using a CT scan

To evaluate whether the effect of supplementation with EPA influences the overall survival using a CT scan

To evaluate and compare the effect of supplementation with EPA on the perceptions of patients through quality of life questionnaires (QLQ) validated such as QLQ-H\&N35

To evaluate the functional status using performance status scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Changes in Body Composition After EPA Supplementation in Head and Neck Patients	NCT02715596	Squamous Cell C...	EPA supplementa... Placebo	18 Years -	Institut Català d'Oncologia
Changes in Body Composition After EPA Supplementation in Head and Neck Patients	NCT02715596	Squamous Cell C...	EPA supplementa... Placebo	18 Years -	Institut Català d'Oncologia

Spots Global Cancer Trial Database for epa supplementation