Quality of Life Clinical Trial
Official title:
Effect of Enteral Supplementation of Omega 3 Fatty Acids on the Quality of Life and Functionality of Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy
Verified date | July 2022 |
Source | Coordinación de Investigación en Salud, Mexico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Health-related Quality of Life (QoL) is a multidimensional construct that allows us to know the patient's perception of well-being, and how this perception is related to their illness and treatment. In clinical research, especially clinical trials, the QoL measurement has become an important element to evaluate. In patients with Head and Neck Squamous Cell Carcinoma (HNSCC), low QoL is associated with Malnutrition (MN), and Cancer Cachexia (CC) is a principal component in its multifactorial etiology. The exacerbated hypercatabolic state of CC is caused by the increase of pro-inflammatory cytokines, Reactive Oxygen Species (ROS), and other catabolic mediators. The clinical manifestation of CC is a continuous decrease in muscle mass (with or without loss of fat mass), which is not entirely reversible with nutritional support and which leads to the functional deterioration of patients. Due to CC, the patients with HNSCC who receive total enteral nutritional support have difficulties in maintaining an optimal nutritional status, and this situation is more frequent during RadioTherapy (RT). An immune-modulator nutrient, Omega-3 fatty acids (O3) have shown efficacy in improving the nutritional and inflammatory parameters of patients with HNSCC; however, little is known about their impact on patients' QoL and Functionality (Fx). Therefore, this clinical trial is proposed to provide information about the usefulness of O3 for improving the Fx and QoL of patients with HNSCC receiving total enteral nutrition during RT.
Status | Terminated |
Enrollment | 9 |
Est. completion date | July 31, 2021 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Head and Neck Squamous Cell Carcinoma (HNSCC) confirmed by histologic - Eligible for receiving total enteral nutrition support through percutaneous endoscopic gastrostomy for the first time - Eligible for receiving RadioTherapy (RT) for the first time Exclusion Criteria: - Allergy to fish - Consumption of anticoagulants - Consumption of any supplement 6 months prior to the experiment - Any contraindication to the performance of the Bioelectrical Impedance Analysis (BIA) (cardiac pacemaker, any metallic prosthesis, inability to stand, severe edema) - Mal-absorption syndrome - Two or more cancer types - Organ dysfunction - Immune diseases - Any hospitalization during the 20 days prior to extraction of the blood sample |
Country | Name | City | State |
---|---|---|---|
Mexico | Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS | Guadalajara | Jalisco |
Lead Sponsor | Collaborator |
---|---|
Coordinación de Investigación en Salud, Mexico |
Mexico,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Global Health Status/Quality of Life (GHS/QoL) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) | The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures. These include five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status / QoL scale (GHS/QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The principle for scoring these scales is the same in all cases: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. | From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2) | |
Primary | Change in Physical Functioning (PF) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) | The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item scales and single-item measures. These include the Physical Functioning Scale and four more functional scales (role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status / QoL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and difficulties). Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." The method for scoring these scales is: 1. Estimate the average of the items that contribute to the scale; this is the raw score. 2. Use a linear transformation to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change. | From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2) | |
Secondary | Changes in serum cancer cachexia-related cytokines: IL (Interleukin)-1a, IL-1b, IL-6, IL-8, IFN? (Interferon gamma), TGF-ß (transforming growth factor beta), and TNF-a (Tumor necrosis factor alpha) | Changes of the serum levels quantified by means of the Enzyme-Linked ImmunoSorbent Assay (ELISA) | From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2) |
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