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Cytokine 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
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mammary Neoplasm, Human

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    August 4, 2017
    Last Updated
    June 18, 2020
    Sponsor
    University of Sao Paulo
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    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

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