NCT02622880

Brief Summary

The purpose of this study is to evaluate the effect of an immune formula , consumed 10 days before surgery , on the number and characteristics of postoperative infections for a period of 30 days in a group of oropharynx, hypopharynx , larynx and oral cavity squamous cell cancer patients, candidates for surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
Last Updated

December 7, 2015

Status Verified

December 1, 2015

Enrollment Period

10 months

First QC Date

November 24, 2015

Last Update Submit

December 2, 2015

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of postoperative infections

    30 days after surgery

Secondary Outcomes (10)

  • Change from baseline Retinol-binding protein

    0 and 30 days

  • Length of post-operative hospital stay

    through study completion, an average of 3 months

  • Mortality

    through study completion, an average of 3 months

  • change from baseline C-reactive protein

    0 and 30 days

  • change from baseline albumin

    0 and 30 days

  • +5 more secondary outcomes

Study Arms (2)

: IMPACT

ACTIVE COMPARATOR

along 10 days before surgery

Dietary Supplement: IMPACT

immunomodulatory supplement

EXPERIMENTAL

along 10 days before surgery

Dietary Supplement: immunomodulatory supplement

Interventions

immunomodulatory supplementDIETARY_SUPPLEMENT

Experimental Group (immunomodulatory supplement STUDY)

immunomodulatory supplement
IMPACTDIETARY_SUPPLEMENT

IMPACT (Nestle Healthcare Nutrition, Minnesota USA) an 'immune-enhancing' feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients.

: IMPACT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women \>18 years
  • Patients with histologically confirmed squamous cell cancer of the oropharynx, hypopharynx , larynx and oral cavity and candidates for neoplastic surgery (undergoing surgery)
  • Adequate cultural level and understanding for the clinical trial. and agree to participate voluntarily in the study and give written informed consent
  • Patients who do not participate in other clinical trials

You may not qualify if:

  • Patients with an active infectious process at the time of the study.
  • Patients who have undergone radiotherapy / chemotherapy prior to surgery.
  • Subjects diagnosed with Type I Diabetes Mellitus
  • Subjects who used oral hypoglycemic agents or insulin.
  • Patients with severe kidney disease, heart, respiratory or liver.
  • Patients with autoimmune diseases or immunosuppressive drugs used.
  • Subjects with dementia, mental illness or diminished cognitive function.
  • Subjects who refuse oral supplements.
  • Subjects who consume vitamin supplements or artificial nutrition, and which can not be suspended at least 1 week before the study and do not accept to suspend it during the study.
  • Subjects with morbid obesity (BMI ≥ 40 kg / m2).
  • Pregnant or breastfeeding
  • Patients diagnosed with epidermoid carcinoma T1 glottic, cordectomy candidate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitairo La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Carmen Gomez Candela

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 7, 2015

Study Start

February 1, 2013

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

December 7, 2015

Record last verified: 2015-12

Locations

ES(1)