Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576986
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-11
Brief Title:
Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy Randomized Double-masked Parallel Single-center Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction In the 2023-2025 period colorectal cancer CRC will be the third most common type of cancer in Brazil The most commonly used therapeutic approaches are chemotherapy QTx and radiotherapy RTx QTx agents such as capecitabine affect both malignant cells and normal cells such as gastrointestinal capillary and immune cells Cellular damage in the gastrointestinal tract GIT results in various symptoms such as mucositis and diarrhea Diarrhea is linked to mucosal damage and can result in dehydration malnutrition and hospitalization leading to cardiovascular complications and death Mucositis is inflammation that affects the GIT This condition makes treatment difficult leading to reductions delays or interruption of QTx These scenarios harm the patients prognosis and quality of life resulting in high costs for symptom control nutritional assistance management of secondary infections and hospitalization The Mucositis Study Group MASCCISOO guidelines recommend the use of probiotics as a preventive measure against diarrhea in cancer patients undergoing QTx andor RTx However the safety of using probiotics in immunosuppressed patients is still controversial and hypotheses are based on epidemiological and experimental studies This makes it necessary to evaluate whether supplementation with pro- or synbiotics before chemotherapy would have the same beneficial results Objective To evaluate the effect of synbiotic supplementation on the prevention incidence and severity of mucositis in cancer patients undergoing QTx Method This is a single-center parallel double-masked randomized clinical trial to be carried out at the Borges da CostaUFMG Outpatient Clinic at Hospital das Clínicas in Belo Horizonte - Minas Gerais HC-BHMG The inclusion criteria are patients diagnosed with CRC eligible for first-line treatment with Capecitabine aged 18 years both sexes signed the informed consent form The study was approved by CEP-UFMG Expected results It is expected that supplementation with synbiotics in the pre-QTx period will promote modulation of the microbiota and strengthening of the intestinal barrier resulting in a lower incidence and severity of mucositis and diarrhea improving the quality of life of these patients
Detailed Description:
Introduction In the triennium 2023-2025 colorectal cancer CRC will be the third most common type of cancer in Brazil The most used therapeutic approaches are chemotherapy QTx and radiotherapy RTx Chemotherapeutic agents such as capecitabine affect both malignant cells and normal cells such as gastrointestinal capillary and immune cells Cellular damage in the gastrointestinal tract GIT results in various symptoms such as mucositis and diarrhea Diarrhea is linked to mucosal injury and can lead to dehydration malnutrition hospitalization cardiovascular complications and death Mucositis on the other hand is inflammation that affects the GIT This condition hinders treatment leading to reductions delays or interruption of QTx These scenarios impair the prognosis and quality of life of the patient resulting in high costs for symptom control nutritional support management of secondary infections and hospitalization The Mucositis Study Group guidelines MASCCISOO recommend the use of probiotics as a preventive measure against diarrhea in cancer patients undergoing QTx andor RTx However the safety of probiotic use in immunosuppressed patients is still controversial and hypotheses are based on epidemiological and experimental studies Therefore it is necessary to evaluate whether supplementation with probiotics or symbiotics before chemotherapy would have the same beneficial results Objective The general objective of this study is to evaluate if symbiotic supplementation can reduce the incidence and severity of oral mucositis in cancer patients undergoing chemotherapy Specific objectives include assessing the tolerability of supplementation analyzing clinical and laboratory parameters related to mucositis and investigating the impact of the intervention on the quality of life of patients Methodology This is a randomized double-blind parallel single-center clinical trial to be conducted at the Borges da Costa Outpatient Clinic located at the Hospital das Clínicas of the Federal University of Minas Gerais in Belo Horizonte HC-UFMG Inclusion criteria involve adult patients aged 18 years of both sexes diagnosed with colorectal cancer and candidates for first-line chemotherapy treatment with Capecitabine alone or in combination with Oxaliplatin treated at HCUFMG under the signature of the Informed Consent Form ICF and able to follow the research guidelines The study was approved by the Research Ethics Committee of UFMG CEP-UFMG under protocol number CAAE 30177920200005149 The study involves 80 participants distributed according to the chemotherapy protocol Patients will be randomly divided into two groups designated as A and B one control group receiving Maltodextrin and the other intervention group receiving Symbiotic The supplementation will be administered for 10 days twice a day before the start of chemotherapy treatment Biological samples such as feces and blood will be collected for analysis of intestinal microbiota short-chain fatty acid SCFA levels presence of infection intestinal permeability and inflammatory markers Biological collections will be performed at different time points throughout the study including before supplementation D0-D1 on the 10th day of supplementation D10 pre-QTx and on days 14 and 21 of the first chemotherapy cycle D14-QTx and D21-QTx Data will be collected through nutritional anthropometric and dietary assessments including the Subjective Global Assessment SGA Anthropometric Assessment Dietary Assessment 24h Recall and Food Frequency Questionnaire as well as assessment of intestinal function and digestive complaints Patients will be monitored daily along with follow-up during treatment and data recording in the electronic medical record Statistical analysis of the data will include sample size calculation appropriate statistical tests and an exploratory approach to evaluate clinical outcomes and study results Expected Results It is expected that the results of this study will provide evidence on the efficacy of symbiotic supplementation in preventing oral mucositis in CRC patients undergoing chemotherapy If the intervention proves to be effective it could contribute to the development of more effective nutritional strategies in managing the side effects of oncological treatment improving the quality of life and well-being of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None