Head and Neck Cancer, Nutrition Therapy, Synbiotics
Conditions
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.
Detailed description
The study will be conducted offering the patients symbiotic product twice a day for seven days after the surgical treatment. Patients will be monitored for the number of stools, stools consistency, abdominal pain and gas overproduction.
Interventions
DIETARY_SUPPLEMENTSymbiotic
Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment
DIETARY_SUPPLEMENTMaltodextrin
Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* head and neck cancer with primary surgical treatment, enteral nutrition by enteral tube.
Exclusion criteria
* three months antibiotic use earlier the surgery, recently radiotherapy or quimiotherapy, inflammatory bowel disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum DAO Enzyme Concentration | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate | 7 days | According to Dindo et al, 2004 |
Countries
Brazil
Participant flow
Recruitment details
This study enrolled patients hospitalized with head and neck cancer from Instituto Alfa de Gastroenterologia, Hospital das Clínicas de Minas Gerais, from October 2014 until April 2016
Pre-assignment details
Of the 40 patients screened, six were ineligible: esophageal cancer (1), cirrhosis (1) and four were inoperable. Forty were randomized (19 - symbiotic group and 21 - control)
Participants by arm
| Arm | Count |
|---|---|
| Symbiotic Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days. | 18 |
| Maltodextrin Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days. | 18 |
| Total | 36 |
Baseline characteristics
| Characteristic | Symbiotic | Maltodextrin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 10 Participants | 22 Participants |
| Nutritional status Malnourished | 12 Participants | 10 Participants | 22 Participants |
| Nutritional status Nourished | 6 Participants | 8 Participants | 14 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
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.
Time frame: 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Symbiotic | Serum DAO Enzyme Concentration | 3 ng/mL |
| Maltodextrin | Serum DAO Enzyme Concentration | 2.5 ng/mL |
Secondary
Infection Rate
According to Dindo et al, 2004
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Symbiotic | Infection Rate | 11 Participants |
| Maltodextrin | Infection Rate | 7 Participants |