NCT02654652

Brief Summary

The purpose of this study is to determine whether the symbiotic use in patients with head and neck cancer impact on intestinal function after surgical treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable head-and-neck-cancer

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

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

June 5, 2019

Completed
Last Updated

June 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

January 7, 2016

Results QC Date

November 14, 2016

Last Update Submit

February 27, 2019

Conditions

Head and Neck CancerSynbioticsNutrition Therapy

Outcome Measures

Primary Outcomes (1)

  • Serum DAO Enzyme Concentration

    The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.

    7 days

Secondary Outcomes (1)

  • Infection Rate

    7 days

Study Arms (2)

Symbiotic

EXPERIMENTAL

Patients will receive the symbiotic product LactoFos twice a day during seven days after surgical treatment. The intervention consists of giving twice a day a sachet of 6g of symbiotic diluted in 20mL of water via nasoenteric tube for seven days, totaling the administration of 14 sachets per intervention.

Dietary Supplement: Symbiotic

Maltodextrin

PLACEBO COMPARATOR

Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment.

Dietary Supplement: Maltodextrin

Interventions

SymbioticDIETARY_SUPPLEMENT

Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment

Also known as: LactoFos
Symbiotic
MaltodextrinDIETARY_SUPPLEMENT

Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment

Maltodextrin

Eligibility Criteria

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

You may qualify if:

  • head and neck cancer with primary surgical treatment, enteral nutrition by enteral tube.

You may not qualify if:

  • three months antibiotic use earlier the surgery, recently radiotherapy or quimiotherapy, inflammatory bowel disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFMG Hospital

Belo Horizonte, Minas Gerais, 30640100, Brazil

Location

Related Publications (2)

  • Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? 1987. Classical article. Nutr Hosp. 2008 Jul-Aug;23(4):400-7. No abstract available.

    PMID: 18702178RESULT

  • Lages PC, Generoso SV, Correia MITD. Postoperative symbiotic in patients with head and neck cancer: a double-blind randomised trial. Br J Nutr. 2018 Jan;119(2):190-195. doi: 10.1017/S0007114517003403. Epub 2017 Dec 26.

    PMID: 29277158DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Results Point of Contact

Title
Dr. Maria Isabel Correia
Organization
Universidade Federal de Minas Gerais
isabel_correia@uol.com.br
+55 31 34098033

Study Officials

  • Priscilla C Lages, bachelor

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 13, 2016

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

June 5, 2019

Results First Posted

June 5, 2019

Record last verified: 2019-02

Locations

BR(1)