NCT04440930

Brief Summary

The aim of this study is to determine the effectiveness of mouthwash with white tea in the prevention of paclitaxel induced oral mucositis in women with breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

September 5, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

June 18, 2020

Last Update Submit

September 1, 2023

Conditions

Oral Mucositis

Keywords

mucositismouthpaclitaxel

Outcome Measures

Primary Outcomes (1)

  • Incidence of oral mucositis grade 2 or higher as measured by the Revised Oral Assessment Guide.

    Nine categories are included in the Revised Oral Assessment Guide tool: voice, lips, mucous, tongue, gums, teeth, saliva, denture and swallowing. Each category is described and rated according to a score of 1 (healthy) to 3 (severe problems).

    up to nine weeks

Secondary Outcomes (4)

  • Frequency of daily mouthwashes

    once a week over a period of nine weeks

  • Frequency of daily tooth brushings

    once a week over a period of nine weeks

  • Pain intensity in the oral cavity as measured on the Numeric Rating Scale (NRS).

    Once a week over a period of nine weeks

  • Date of onset of oral mucositis grade 2 or higher as measured by Revised Oral Assessment Guide.

    Once a week until oral mucositis occurs up to nine weeks

Study Arms (2)

White tea

EXPERIMENTAL
Other: White tea

Salt water with soda

ACTIVE COMPARATOR
Other: Salt water with soda

Interventions

White teaOTHER

Mouthwash with white tea five to six times a day for nine weeks

White tea
Salt water with sodaOTHER

Mouthwash with salt water and soda eight to ten times a day for nine weeks

Salt water with soda

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman with breast cancer
  • Planned neoadjuvant or adjuvant paclitaxel treatment
  • Age ≥ 18 years
  • Understand and speak Danish
  • Written and orally informed consent

You may not qualify if:

  • \- Palliative treatment with paclitaxel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, Denmark

Location

MeSH Terms

Conditions

StomatitisMucositis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Erik H Jakobsen, MD

    Vejle Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 22, 2020

Study Start

September 2, 2020

Primary Completion

March 28, 2023

Study Completion

April 30, 2023

Last Updated

September 5, 2023

Record last verified: 2023-09

Locations

DK(1)