Back to resultsCytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy
Primary Purpose
Mammary Neoplasm, Human, Periodontal Diseases, Chemotherapy Effect
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non surgical periodontal Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Mammary Neoplasm, Human
Eligibility Criteria
Inclusion Criteria:
- All patients were diagnosed with periodontitis (P) The inclusion criteria were:Loss of clinical insertion (CAL) ≥ 5mm and PD probing depth ≥ 6mm in ≥ 30% of sites; ≥20 teeth; radiographic bone loss that extends to the middle level of the root; presence of supragingival and subgingival calculus according to the severity of periodontal damage. Grade B was assessed indirectly, considering radiographic bone loss in the tooth most affected by dentition as a function of age (0.25 to 1.0).
Exclusion Criteria:
- 1) scaling and root planning or antibiotic treatment in the previous 6 months; 2) systemic diseases that could affect the progression of periodontitis (e.g., diabetes, hypertension, cardiovascular diseases); 3) extensive prosthetic involvement; 4) long-term administration of anti-inflammatory medication; 6) smokers and former smokers; 7) pregnancy or lactation; 8) orthodontic therapy; 9) use of mouth rinses containing antimicrobials in the preceding 2 months; 10) patients had previously received chemotherapy or radiotherapy; 11) patients with metastasis and/or patients with neoadjuvant chemotherapy.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Non surgical periodontal treatment
Arm Description
The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia.
Outcomes
Primary Outcome Measures
Cytokines
Cytokine levels and changes before and after post treatment
Secondary Outcome Measures
Correlation of cytokines
cytokine levels between parameters clinical
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03244943
Brief Title
Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy
Official Title
Effects of Non-surgical Periodontal Treatment on the Gingival Crevicular Fluid Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (undefined)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: This study evaluated the effects of non-surgical periodontal therapy (NSPT) on the cytokine profile and the correlation to clinical parameters of patients undergoing chemotherapy for breast cancer.
Materials and methods: 40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding on probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.
Detailed Description
The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammary Neoplasm, Human, Periodontal Diseases, Chemotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
40 patients were allocated: periodontitis patients (P) (n=20) and breast cancer with periodontitis patients (CAN/P) (n=20). The clinical parameters: probing depth (PD), clinical attachment level (CAL), plaque index (PI), Bleeding of probing (BOP) and levels of IFN-γ, IL-4, IL-10, TGF-β, IL-17, IL-2, IL-6, IL-1β and TNF-α in gingival crevicular fluid (GCF) were evaluated at baseline, 45 and 180 days after therapy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non surgical periodontal treatment
Arm Type
Other
Arm Description
The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Non surgical periodontal Treatment
Other Intervention Name(s)
scaling and root planning (SRP) under local anesthesia.
Intervention Description
The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.
Primary Outcome Measure Information:
Title
Cytokines
Description
Cytokine levels and changes before and after post treatment
Time Frame
baseline, 45 days, 180 days
Secondary Outcome Measure Information:
Title
Correlation of cytokines
Description
cytokine levels between parameters clinical
Time Frame
baseline, 45 days, 180 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with cancer and without breast cancer between 35 and 70 years of age
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients were diagnosed with periodontitis (P) The inclusion criteria were:Loss of clinical insertion (CAL) ≥ 5mm and PD probing depth ≥ 6mm in ≥ 30% of sites; ≥20 teeth; radiographic bone loss that extends to the middle level of the root; presence of supragingival and subgingival calculus according to the severity of periodontal damage. Grade B was assessed indirectly, considering radiographic bone loss in the tooth most affected by dentition as a function of age (0.25 to 1.0).
Exclusion Criteria:
1) scaling and root planning or antibiotic treatment in the previous 6 months; 2) systemic diseases that could affect the progression of periodontitis (e.g., diabetes, hypertension, cardiovascular diseases); 3) extensive prosthetic involvement; 4) long-term administration of anti-inflammatory medication; 6) smokers and former smokers; 7) pregnancy or lactation; 8) orthodontic therapy; 9) use of mouth rinses containing antimicrobials in the preceding 2 months; 10) patients had previously received chemotherapy or radiotherapy; 11) patients with metastasis and/or patients with neoadjuvant chemotherapy.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De- identified individual participant for all primary and secundary outcome measures will be made available
IPD Sharing Time Frame
6 months of study completion
IPD Sharing Access Criteria
data access request will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement
Learn more about this trial
Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy
We'll reach out to this number within 24 hrs