Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Maltodextrin | Placebo Comparator | Patients will receive 6g of maltodextrin twice a day during seven days after surgical treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbiotic | Dietary Supplement | Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rate | According to Dindo et al, 2004 | 7 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Priscilla C Lages, bachelor | Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UFMG Hospital | Belo Horizonte | Minas Gerais | 30640100 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18702178 | Result | 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. | |
| 29277158 | Derived | 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. |
Not provided
Not provided
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)
This study enrolled patients hospitalized with head and neck cancer from Instituto Alfa de Gastroenterologia, Hospital das ClÃnicas de Minas Gerais, from October 2014 until April 2016
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Symbiotic | Patients will receive twice a day the symbiotic product during seven days after surgical treatment LactoFos: Patients will receive the product twice a day during seven days after surgical treatment |
| FG001 | Maltodextrin | Patients will receive twice a day the placebo product during seven days after surgical treatment Maltodextrin: Patients will receive maltodextrin twice a day during seven days after surgical treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Symbiotic | Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days. |
| BG001 | Maltodextrin | Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Full Range | ng/mL | 7 days |
|
30 days
All-cause Mortality
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symbiotic | Patients received, twice a day, the symbiotic product (LactoFos) for at least 5 days and the maximum of 7 days. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maria Isabel Correia | Universidade Federal de Minas Gerais | +55 31 34098033 | isabel_correia@uol.com.br |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C008315 | maltodextrin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Maltodextrin | Dietary Supplement | Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Nutritional status | According to Detsky et al, 1987 | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Infection Rate | According to Dindo et al, 2004 | Posted | Count of Participants | Participants | 7 days |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Maltodextrin | Patients will receive twice a day the placebo product (Maltodextrin) or at least 5 days and the maximum of 7 days. | 0 | 18 | 0 | 18 |
Not provided
Not provided