Cytokine Profiles in Breast Cancer Patients Undergoing Chemotherapy

NCT03244943 | Completed DMC

• 1 other identifier: 37030514.7.0000.5419
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mammary Neoplasm, Human; Periodontal Diseases; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• Cytokines

  Cytokine levels and changes before and after post treatment

  baseline, 45 days, 180 days

Secondary Outcomes (1)

• Correlation of cytokines

  baseline, 45 days, 180 days

Study Arms (1)

Non surgical periodontal treatment

OTHER

The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia.

Procedure: Non surgical periodontal Treatment

Interventions

Non surgical periodontal Treatment PROCEDURE

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.

Also known as: scaling and root planning (SRP) under local anesthesia.

Non surgical periodontal treatment

Eligibility Criteria

• Age: 35 Years - 70 Years
• Gender Eligibility Details: Women with cancer and without breast cancer between 35 and 70 years of age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

MeSH Terms

Conditions

Breast Neoplasms; Periodontal Diseases

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of periodontics

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 10, 2017
• Study Start: August 1, 2015
• Primary Completion: December 12, 2016
• Study Completion: July 31, 2017
• Last Updated: June 22, 2020

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months of study completion
• Access Criteria: data access request will be reviewed by an external independent review panel. Requestors will be required to sign a data access agreement