Enteral Omega 3 During Radiotherapy to Improve the Quality of Life and Functionality of Head and Neck Cancer Patients

NCT03720158 | Terminated DMC

• 1 other identifier: 2017-785-110
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Quality of Life; Radiotherapy; Complications

Keywords

Head and Neck Neoplasms; Omega 3 PolyUnsaturated Fatty Acid (PUFA); Quality of Life; Radiotherapy; Cancer Cachexia

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (1)

• 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)

  From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)

Study Arms (2)

Omega 3 Group

EXPERIMENTAL

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)

Dietary Supplement: Omega 3 Group

Placebo or Control Group

PLACEBO COMPARATOR

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)

Dietary Supplement: Placebo or Control Group

Interventions

Omega 3 Group DIETARY_SUPPLEMENT

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

Also known as: Enteral administration of Omega 3 Fatty Acids

Omega 3 Group

Placebo or Control Group DIETARY_SUPPLEMENT

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)

Also known as: Enteral administration of Placebo

Placebo or Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (10)

• 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: 28382514 BACKGROUND

• 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: 23266003 BACKGROUND

• 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: 14689999 BACKGROUND

• 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: 9243270 BACKGROUND

• 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: 23379517 BACKGROUND

• 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: 21296615 BACKGROUND

• 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: 23845698 BACKGROUND

• 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: 16768028 BACKGROUND

• 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: 17408963 BACKGROUND

• 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.

  PMID: 29505143 BACKGROUND

Related Links

• World Health Organization. Estimated crude rate of incident cases, both sexes, worldwide (top 20 cancer sites) in 2012

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Luz Ma. Adriana Balderas-Peña, PhD

  Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 25, 2018
• Study Start: October 10, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)