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Head and Neck Squamous Cell CarcinomaNCT03720158

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

A study testing Omega 3 Group in people with Head and Neck Squamous Cell Carcinoma and Quality of Life, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Omega 3 Group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
1 siteMexico
Study dates
10 Oct 2018to 31 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Organ dysfunction
  • Immune diseases
  • Any hospitalization during the 20 days prior to extraction of the blood sample

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Unidad de Investigación Biomédica 02, UMAE HE CMNO IMSS

    Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

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

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.

Read the detailed description
  • 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.
  • 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.
Being tested
Omega 3 Group, Placebo or Control Group
Keywords
Head and Neck Neoplasms, Omega 3 PolyUnsaturated Fatty Acid (PUFA), Quality of Life, Radiotherapy, Cancer Cachexia
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omega 3 GroupDietary supplement

    Also called Enteral administration of Omega 3 Fatty Acids

    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

  • Placebo or Control GroupDietary supplement

    Also called Enteral administration of Placebo

    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)

Study groups in NCT03720158
Study groupRoleWhat they receive
Omega 3 GroupExperimentalFive 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)
Receives: Dietary Supplement: Omega 3 Group
Placebo or Control GroupPlacebo comparatorFive 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)
Receives: Dietary Supplement: Placebo or Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  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.

    Measured: 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)

  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)

    Changes of the serum levels quantified by means of the Enzyme-Linked ImmunoSorbent Assay (ELISA)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start10 Oct 2018
  3. Primary completion31 Jul 2021
  4. Study completion31 Jul 2021

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03720158
Sponsor's protocol ID
2017-785-110
Status last verified
Jul 2022
First submitted
15 Oct 2018
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28382514

  • 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.

    PubMed 23266003

  • 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.

    PubMed 14689999

  • 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.

    PubMed 9243270

  • 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.

    PubMed 23379517

  • 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.

    PubMed 21296615

  • 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.

    PubMed 23845698

  • Planas M, Puiggros C, Redecillas S. [Contribution of nutritional support to fight cancer cachexia]. Nutr Hosp. 2006 May;21 Suppl 3:27-36. Spanish.

    PubMed 16768028

  • 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.

    PubMed 17408963

  • 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.

    PubMed 29505143

Questions about this trial

What is this clinical trial studying?

A study testing Omega 3 Group in people with Head and Neck Squamous Cell Carcinoma and Quality of Life, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: 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.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (time frame: From baseline (time 0) up to the ending of RT (from 5-7 weeks) (time 1); from baseline up to 12 weeks (time 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03720158, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.

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