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Effect of Omega-3 Supplements on the Prevention of Cachexia in Head and Neck Cancer Treated With Radio(Chemo)Therapy (NUTRIOM)

Primary Purpose

Cancer Cachexia, Head and Neck Cancer

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

BioMega SDA®

Sunflower oil high oleic

About this trial

This is an interventional supportive care trial for Cancer Cachexia focused on measuring head and neck cancer, omega-3 fatty acid supplementation, echium oil, weight loss, cancer cachexia, body composition, biomarker, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed squamous cell carcinoma of the head and neck region, generally cancer of the oral cavity, (naso)pharynx and larynx. Cancer of the parotid gland, or nasal cavity and paranasal sinuses are excluded, as well as cT1 N0 M0 tumours of the glottis.
Primary cancer or relapse, eligible for primary or adjuvant radiotherapy with or without systemic treatment, with curative intent
TNM stage I to IVB, without distant metastases
Patients should be older than 18 at the time of enrolment
Patients should be able to adequately communicate in Dutch or French

Exclusion Criteria:

Patients younger than 18 years at the time of recruitment
Pregnant or lactating women
Patients presenting with another non-cured cancer (PSA or CEA not within normal range as determined by the treating physician)
Patients that already underwent a radio(chemo)therapy treatment within the last 6 months
Patients taking oral anticoagulants or LMWH at therapeutic doses
Patients taking anti-epileptics
Patients with an indication of heart failure NYHA 3 or 4, or presence of an implantable cardioverter-defibrillator
Patients with a pacemaker will be excluded from BIA-analysis
Patients presenting with active intestinal co-morbidity, precluding adequate dietary intake or interfering with the absorption of the nutritional supplements (eg Crohn's disease)
Patients with a known eating disorder (eg anorexia nervosa, bulimia nervosa)
Patients with uncontrollable diabetes
HIV-positive patients
Patients with (severe) dementia (DSM-IV criteria)
Patients actively taking fish oil, echium oil or omega-3 FA supplements in the last 4 weeks before enrolment

Sites / Locations

Ghent University Hospital
General Hospital Groeninge, Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

omega-3 fatty acid supplementation

standard nutritional support

Arm Description

omega-3 fatty acid supplementation (echium oil)

sunflower oil supplementation

Outcomes

Primary Outcome Measures

prevention of therapy-related weight loss

difference between body weight at baseline and end of therapy

Secondary Outcome Measures

determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition

measurement of evolution in body composition (baseline - week 4); measurement of evolution in quality of life (baseline - week 4 - end therapy); measurement of adverse events (CTCAE v4.0)in both groups

establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition

evolution percentage fat and lean mass (baseline - week 4) as determined by Bio-Elektrical Impedance (BIA) and Dual Energy X-ray Absorptiometry (DXA); evolution grip strength (kg) (baseline - week 4) as determined by JAMAR® hydraulic hand dynamometer

identification of potential clinical risk factors of cachexia

identification of nutritional parameters (obtained from validated nutritional screeners and PG-SGA), demographic, tumour and therapy characteristics, physical, emotional, financial, functional, nutritional and psycho-social characteristics (obtained from EORTC QLQ C30 & HN35), and body composition measurements (% fat, % lean mass, phase angle obtained from BIA, DXA and hand dynamometer)

evaluation of the use and reliability of different validated nutritional screening tools in this population

screening with Short Nutritional Assessment Questionnaire (SNAQ), Mini-Nutritional Assessment short-form (MNA-SF), Malnutrition Universal screening tool (MUST), Nutritional risk screening (NRS 2002), Malnutrition screening tool (MST) and the nutrition risk score (NRS); nutritional assessment with Patient Generated - Subjective Global Assessment (PG-SGA) as gold standard

identification and evaluation of potential biomarkers for therapy-induced cachexia

identification of serum biomarkers and Single Nucleotide Polymorphisms (SNP)

measurement of difference in quality of life

measurement of quality of life (baseline, week 4, end therapy) with EORTC QLQ C30&HN35

dropout and compliance to nutritional supplements

number of sachets consumed; omega-3 fatty acid profile as marker for therapy compliance

Full Information

NCT ID

NCT01596933

First Posted

May 4, 2012

Last Updated

March 9, 2015

Sponsor

General Hospital Groeninge

Collaborators

University Hospital, Ghent

1. Study Identification

Unique Protocol Identification Number

NCT01596933

Brief Title

Effect of Omega-3 Supplements on the Prevention of Cachexia in Head and Neck Cancer Treated With Radio(Chemo)Therapy

Acronym

NUTRIOM

Official Title

Multi-centric, Placebo-controlled Trial of Omega-3 Fatty Acid Supplementation in Weight Maintenance and Preservation of Lean Body Mass, in (Pre)Cachectic Head and Neck Cancer Patients, Undergoing Curative Radio(Chemo)Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

General Hospital Groeninge

Collaborators

University Hospital, Ghent

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Cancer cachexia is a complex metabolic process affecting up to 80% of patients suffering from an advanced-stage cancer. Moreover, 20 to 40% of all cancer deaths are caused directly by cachexia. Head and neck (H&N) cancer patients are nutritionally vulnerable since tumour localisation can interfere with food intake, since alcohol and tobacco abuse - two etiological risk factors of H&N cancer - are associated with nutritional deficits, and since the intensive treatment can lead to progressive weight loss. Recently, omega-3 fatty acids have gained interest for their beneficial effects in several diseases. Moreover, nutritional supplementation enriched with omega-3 FA could potentially maintain body weight in cancer patients undergoing intensive treatment. Aims In this study, the investigators want to evaluate the use of omega-3 FA supplementation as nutritional and the investigators would like to identify potential risk factors, biomarkers and objective measurement tools which can predict therapy-induced cachexia.

Detailed Description

Design A prospective, placebo-controlled trial. H&N cancer patients eligible for curative treatment will be randomised to receive standard nutritional support with placebo (15ml/day Sunflower oil, control group) or nutritional support with omega-3 FA supplementation (15ml/day Echium oil, experimental group) during radio(chemo)therapy. All patients will undergo a nutritional screening (Patient-Generated Subjective Global Assessment), a quality of life evaluation (EORTC QLQ C30 & HN35) and will be asked to keep a 3-day food diary at the start of their therapy, and again during the 4th week and the end of therapy. Body composition and grip strength will be measured with bio-electrical impedance (BIA) analysis, Dual X-ray absorptiometry (DXA) and the JAMAR® hydraulic hand dynamometer once at baseline, and again in the 4th week of therapy. Blood samples are collected at baseline, and in the 4th week of therapy to (1) verify compliance rate by measuring fatty acid concentration, (2) verify the presence of potential biomarkers that can predict cachexia and (3) to detect the presence of SNPs associated with severe acute dysphagia. Demographic data, tumour characteristics and therapy-related toxicity will also be collected. Population Newly diagnosed non-metastatic (stage I-IVB) head and neck cancer patients (≥18 or older) eligible for curative primary or adjuvant radiotherapy with or without systemic therapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer Cachexia, Head and Neck Cancer

Keywords

head and neck cancer, omega-3 fatty acid supplementation, echium oil, weight loss, cancer cachexia, body composition, biomarker, quality of life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

91 (Actual)

8. Arms, Groups, and Interventions

Arm Title

omega-3 fatty acid supplementation

Arm Type

Experimental

Arm Description

omega-3 fatty acid supplementation (echium oil)

Arm Title

standard nutritional support

Arm Type

Placebo Comparator

Arm Description

sunflower oil supplementation

Intervention Type

Dietary Supplement

Intervention Name(s)

BioMega SDA®

Intervention Description

Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

Sunflower oil high oleic

Intervention Description

Sunflower oil high oleic, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy

Primary Outcome Measure Information:

Title

prevention of therapy-related weight loss

Description

difference between body weight at baseline and end of therapy

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

determination of beneficial (and possible side) effects of omega-3 FA supplements in general, and specifically on body weight and body composition

Description

Time Frame

7 weeks

Title

establish feasibility, variability and distribution of BIA, DXA and JAMAR® as objective measurement tools of body composition

Description

Time Frame

7 weeks

Title

identification of potential clinical risk factors of cachexia

Description

Time Frame

7 weeks

Title

evaluation of the use and reliability of different validated nutritional screening tools in this population

Description

Time Frame

7 weeks

Title

identification and evaluation of potential biomarkers for therapy-induced cachexia

Description

identification of serum biomarkers and Single Nucleotide Polymorphisms (SNP)

Time Frame

7 weeks

Title

measurement of difference in quality of life

Description

measurement of quality of life (baseline, week 4, end therapy) with EORTC QLQ C30&HN35

Time Frame

7 weeks

Title

dropout and compliance to nutritional supplements

Description

number of sachets consumed; omega-3 fatty acid profile as marker for therapy compliance

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed squamous cell carcinoma of the head and neck region, generally cancer of the oral cavity, (naso)pharynx and larynx. Cancer of the parotid gland, or nasal cavity and paranasal sinuses are excluded, as well as cT1 N0 M0 tumours of the glottis. Primary cancer or relapse, eligible for primary or adjuvant radiotherapy with or without systemic treatment, with curative intent TNM stage I to IVB, without distant metastases Patients should be older than 18 at the time of enrolment Patients should be able to adequately communicate in Dutch or French Exclusion Criteria: Patients younger than 18 years at the time of recruitment Pregnant or lactating women Patients presenting with another non-cured cancer (PSA or CEA not within normal range as determined by the treating physician) Patients that already underwent a radio(chemo)therapy treatment within the last 6 months Patients taking oral anticoagulants or LMWH at therapeutic doses Patients taking anti-epileptics Patients with an indication of heart failure NYHA 3 or 4, or presence of an implantable cardioverter-defibrillator Patients with a pacemaker will be excluded from BIA-analysis Patients presenting with active intestinal co-morbidity, precluding adequate dietary intake or interfering with the absorption of the nutritional supplements (eg Crohn's disease) Patients with a known eating disorder (eg anorexia nervosa, bulimia nervosa) Patients with uncontrollable diabetes HIV-positive patients Patients with (severe) dementia (DSM-IV criteria) Patients actively taking fish oil, echium oil or omega-3 FA supplements in the last 4 weeks before enrolment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip R Debruyne, MD PhD

Organizational Affiliation

General Hospital Groeninge

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tom Boterberg, MD PhD

Organizational Affiliation

University Hospital, Ghent

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ghent University Hospital

City

Ghent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

General Hospital Groeninge, Cancer Center

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

25293388

Citation

Pottel L, Lycke M, Boterberg T, Pottel H, Goethals L, Duprez F, Maes A, Goemaere S, Rottey S, Foubert I, Debruyne PR. Echium oil is not protective against weight loss in head and neck cancer patients undergoing curative radio(chemo)therapy: a randomised-controlled trial. BMC Complement Altern Med. 2014 Oct 7;14:382. doi: 10.1186/1472-6882-14-382.

Results Reference

derived

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Effect of Omega-3 Supplements on the Prevention of Cachexia in Head and Neck Cancer Treated With Radio(Chemo)Therapy

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