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

NCT ID: NCT01596933

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-02-28

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

Conditions

Cancer Cachexia; Head and Neck Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

omega-3 fatty acid supplementation

omega-3 fatty acid supplementation (echium oil)

Group Type: EXPERIMENTAL

BioMega SDA®

Intervention Type: DIETARY_SUPPLEMENT

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

standard nutritional support

sunflower oil supplementation

Group Type: PLACEBO_COMPARATOR

Sunflower oil high oleic

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

BioMega SDA®

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

Intervention Type: DIETARY_SUPPLEMENT

Sunflower oil high oleic

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

General Hospital Groeninge

OTHER

Sponsor Role: lead

Responsible Party

Dr. Philip Debruyne

Consultant Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip R Debruyne, MD PhD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Groeninge

Tom Boterberg, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

General Hospital Groeninge, Cancer Center

Kortrijk, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 25293388 (View on PubMed)

Other Identifiers

NKP_CA_04

Identifier Type: -

Identifier Source: org_study_id