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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
54
2.7 g EPA supplementation in a 15 cc emulsion stick-pack
placebo in 15 cc emulsion stick-pack
Institut Catala d'Oncologia- L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
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 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.
Time frame: 3 years
the effect of supplementation with EPA on muscle mass after induction chemotherapy using imaging such as CT scan
To evaluate on muscle mass using imaging such as CT scan
Time frame: 10 weeks
Evolution of nutritional status of patients over oncology-specific treatment in both arms. using PG-VGS
To assess the evolution of nutritional status using PG-VGS (patient generated subjective global assessment)
Time frame: 1 year
The effect of supplementation with EPA regarding acute toxicity during treatment.using the CTCAE v4 criteria
To evaluate the frequency of acute toxicity using the CTCAE v4 criteria
Time frame: 1 year
The effect of supplementation with EPA in relation to chronic toxicity 2 years after oncologic treatment. (using the CTCAE v4 criteria)
To evaluate the frequency of chronic toxicity using the CTCAE v4 criteria
Time frame: 2 years
The impact of supplementation with EPA in the loco-regional control at 2 years after completing cancer treatment.
To evaluate whether the effect of supplementation with EPA influences the loco-regional control using a CT scan
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires.
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
Time frame: 2 year
The adherence to EPA. (using record EPA/placebo dispensing and return and blood samples at baseline and throughout the cancer treatment)
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
Time frame: 1 year
The functional status of patients throughout the treatment. (functional status using hand grip)
To evaluate the functional status using hand grip
Time frame: 1 year
The need for nutritional support and nutritional intervention required during cancer treatment among patients supplemented with EPA or placebo.
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.
Time frame: 1 year
The impact of supplementation with EPA on the recurrence-free survival at 2 years after completing cancer treatment.
To evaluate whether the effect of supplementation with EPA influences the recurrence-free survival using a CT scan
Time frame: 2 years
The impact of supplementation with EPA on the overall survival at 2 years after completing cancer treatment.
To evaluate whether the effect of supplementation with EPA influences the overall survival using a CT scan
Time frame: 2 years
The effect of supplementation with EPA on the perceptions of patients through quality of life validated questionnaires.
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
Time frame: 2 years
The functional status of patients throughout the treatment. (functional status using performance status scale)
To evaluate the functional status using performance status scale
Time frame: 1 year