Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-01-01 @ 3:55 PM
Study NCT ID:
NCT03720158
Status:
TERMINATED
Last Update Posted:
2022-07-25
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'The activities in the study hospital were seriously impacted by the medical care of COVID patients, affecting the medical management protocol of the study population. This situation does not allow to continue with the recruitment of patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2018-10-15', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)', 'description': '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.'}, {'measure': 'Change in Physical Functioning (PF) subscale of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in serum cancer cachexia-related cytokines: IL (Interleukin)-1a, IL-1b, IL-6, IL-8, IFNγ (Interferon gamma), TGF-β (transforming growth factor beta), and TNF-α (Tumor necrosis factor alpha)', 'timeFrame': 'From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)', 'description': 'Changes of the serum levels quantified by means of the Enzyme-Linked ImmunoSorbent Assay (ELISA)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head and Neck Neoplasms', 'Omega 3 PolyUnsaturated Fatty Acid (PUFA)', 'Quality of Life', 'Radiotherapy', 'Cancer Cachexia'], 'conditions': ['Head and Neck Squamous Cell Carcinoma', 'Quality of Life', 'Radiotherapy; Complications']}, 'referencesModule': {'references': [{'pmid': '28382514', 'type': 'BACKGROUND', 'citation': 'Perloy A, Maasland DHE, van den Brandt PA, Kremer B, Schouten LJ. Intake of meat and fish and risk of head-neck cancer subtypes in the Netherlands Cohort Study. Cancer Causes Control. 2017 Jun;28(6):647-656. doi: 10.1007/s10552-017-0892-0. Epub 2017 Apr 5.'}, {'pmid': '23266003', 'type': 'BACKGROUND', 'citation': 'Righini CA, Timi N, Junet P, Bertolo A, Reyt E, Atallah I. Assessment of nutritional status at the time of diagnosis in patients treated for head and neck cancer. Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Feb;130(1):8-14. doi: 10.1016/j.anorl.2012.10.001. Epub 2012 Dec 20.'}, {'pmid': '14689999', 'type': 'BACKGROUND', 'citation': 'Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Nutritional deterioration in cancer: the role of disease and diet. Clin Oncol (R Coll Radiol). 2003 Dec;15(8):443-50. doi: 10.1016/s0936-6555(03)00155-9.'}, {'pmid': '9243270', 'type': 'BACKGROUND', 'citation': 'van Bokhorst-de van der Schueren MA, van Leeuwen PA, Sauerwein HP, Kuik DJ, Snow GB, Quak JJ. Assessment of malnutrition parameters in head and neck cancer and their relation to postoperative complications. Head Neck. 1997 Aug;19(5):419-25. doi: 10.1002/(sici)1097-0347(199708)19:53.0.co;2-2.'}, {'pmid': '23379517', 'type': 'BACKGROUND', 'citation': 'Sheth CH, Sharp S, Walters ER. Enteral feeding in head and neck cancer patients at a UK cancer centre. J Hum Nutr Diet. 2013 Oct;26(5):421-8. doi: 10.1111/jhn.12029. Epub 2013 Feb 5.'}, {'pmid': '21296615', 'type': 'BACKGROUND', 'citation': 'Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.'}, {'pmid': '23845698', 'type': 'BACKGROUND', 'citation': 'Alshadwi A, Nadershah M, Carlson ER, Young LS, Burke PA, Daley BJ. Nutritional considerations for head and neck cancer patients: a review of the literature. J Oral Maxillofac Surg. 2013 Nov;71(11):1853-60. doi: 10.1016/j.joms.2013.04.028. Epub 2013 Jul 9.'}, {'pmid': '16768028', 'type': 'BACKGROUND', 'citation': 'Planas M, Puiggros C, Redecillas S. [Contribution of nutritional support to fight cancer cachexia]. Nutr Hosp. 2006 May;21 Suppl 3:27-36. Spanish.'}, {'pmid': '17408963', 'type': 'BACKGROUND', 'citation': 'Murphy BA, Ridner S, Wells N, Dietrich M. Quality of life research in head and neck cancer: a review of the current state of the science. Crit Rev Oncol Hematol. 2007 Jun;62(3):251-67. doi: 10.1016/j.critrevonc.2006.07.005. Epub 2007 Apr 3.'}, {'pmid': '29505143', 'type': 'BACKGROUND', 'citation': 'Mulasi U, Vock DM, Kuchnia AJ, Jha G, Fujioka N, Rudrapatna V, Patel MR, Teigen L, Earthman CP. Malnutrition Identified by the Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition Consensus Criteria and Other Bedside Tools Is Highly Prevalent in a Sample of Individuals Undergoing Treatment for Head and Neck Cancer. JPEN J Parenter Enteral Nutr. 2018 Jan;42(1):139-147. doi: 10.1177/0148607116672264. Epub 2017 Dec 11.'}], 'seeAlsoLinks': [{'url': 'http://gco.iarc.fr/today/online-analysis-multi-bars?mode=cancer&mode_population=continents&population=900&sex=0&cancer=29&type=0&statistic=0&prevalence=0&color_palette=default', 'label': 'World Health Organization. Estimated crude rate of incident cases, both sexes, worldwide (top 20 cancer sites) in 2012'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "* Objective: To determine the effect of the daily addition of five mL of an O3 highly concentrated substance (EicosaPentaenoic Acid - EPA: 2.25 g and DocosaHexaenoic Acid - DHA: 1.08 g), to the standard enteral nutrition diet during RT (5-7 weeks), on the Quality of Life (QoL) and Functionality (Fx) of patients with HNSCC.\n* Methods: Randomized, double-blinded, controlled clinical trial. Patients with HNSCC (ages ranging from 18-80 years) who will receive total enteral nutrition support through percutaneous endoscopic gastrostomy and RT for the first time will be invited to participate in the study. Exclusion criteria are fish allergy, anticoagulant consumption, any supplement consumption 6 months prior to the experiment, any contraindication to the performance of the body composition analysis using bioelectrical impedance (Bioelectrical Impedance Analysis, BIA) (cardiac pacemaker, any metallic prosthesis, inability to stand, severe edema), or the presence of the mal-absorption syndrome, two or more cancer types, organ dysfunction, immune diseases, or any hospitalization during the 20 days prior to extraction of the blood sample. Patients with the consumption of any other nutritional supplement or diagnosed with any other cancer during the treatment period, or with insufficient or incorrectly processed blood-serum samples will be eliminated. After expressing their willingness to participate via the signing of the informed consent document, 86 patients with HNSCC will be allocated into two groups: The O3 Group will have the addition of 5 mL of an O3 highly concentrated substance containing 2.25 g of EPA and 1.08 g of DHA to the standard enteral diet during RT (5-7 weeks), and the Placebo or Control Group will have the addition of 5 mL of a placebo (pigmented and flavored corn oil) in a similar manner. All patients will be seen every 4 weeks at the Nutrition Support Service for nutritional assessment and counseling, and to receive the enteral nutrition containers (standard polymeric diet). On the same day, a Research Assistant (who will be blinded) will provide the supplements or the placebo. The patients' sociodemographic and clinical information, body composition, albumin, hemoglobin, C-reactive protein, tumor cachexia-related cytokines: IL (Interleukin) 1a, IL-1b, IL-6, IL-8, IFNγ (Interferon gamma), TGF-β (transforming growth factor beta), and TNF-α (Tumor necrosis factor alpha); and responses for the European Organisation for Research and Treatment of Cancer Quality of Life C-30 (EORTC-QLQ-C30) with the Head and Neck Cancer module (EORTC-QLQ-H\\&N35) questionnaires will be collected at the beginning of RT, at the end of RT, and 12 weeks after starting RT. Statistical analysis includes descriptive statistics, inference statistics (Student t-test, Mann-Whitney test, one-way ANOVA with Bonferroni correction, Kruskal-Wallis with Dunn's non-parametric test), and the Cox regression; an intention-to-treat analysis will be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Head and Neck Squamous Cell Carcinoma (HNSCC) confirmed by histologic\n* Eligible for receiving total enteral nutrition support through percutaneous endoscopic gastrostomy for the first time\n* Eligible for receiving RadioTherapy (RT) for the first time\n\nExclusion Criteria:\n\n* Allergy to fish\n* Consumption of anticoagulants\n* Consumption of any supplement 6 months prior to the experiment\n* Any contraindication to the performance of the Bioelectrical Impedance Analysis (BIA) (cardiac pacemaker, any metallic prosthesis, inability to stand, severe edema)\n* Mal-absorption syndrome\n* Two or more cancer types\n* Organ dysfunction\n* Immune diseases\n* Any hospitalization during the 20 days prior to extraction of the blood sample'}, 'identificationModule': {'nctId': 'NCT03720158', 'briefTitle': 'Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2017-785-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega 3 Group', 'description': 'Five mL of an Omega-3 highly concentrated substance (containing 2.25 g of EPA and 1.08 g of DHA) will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks)', 'interventionNames': ['Dietary Supplement: Omega 3 Group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo or Control Group', 'description': 'Five mL of pigmented and flavored corn oil will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks)', 'interventionNames': ['Dietary Supplement: Placebo or Control Group']}], 'interventions': [{'name': 'Omega 3 Group', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Enteral administration of Omega 3 Fatty Acids'], 'description': 'Five mL of an Omega-3 highly concentrated substance (containing 2.25 g of EPA and 1.08 g of DHA) will be added daily to the standard enteral diet during the entire radiotherapy', 'armGroupLabels': ['Omega 3 Group']}, {'name': 'Placebo or Control Group', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Enteral administration of Placebo'], 'description': 'Five mL of pigmented and flavored corn oil will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks)', 'armGroupLabels': ['Placebo or Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}], 'overallOfficials': [{'name': 'Luz Ma. Adriana Balderas-Peña, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}