NCT05717972

Brief Summary

Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

January 17, 2023

Last Update Submit

February 6, 2023

Conditions

Distress, EmotionalSleep

Outcome Measures

Primary Outcomes (4)

  • Sleep Quality Index

    The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.

    Change from Baseline Sleep Quality Index at Day 20

  • Sleep Quality Index

    The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.

    Change from Baseline Sleep Quality Index at Day32

  • Anxiety

    The State-Trait Anxiety Inventory, STAI. It includes two types of anxiety. The state anxiety is considered to be individual's temporary perception toward fear, nervousness, discomfort etc. and the trait anxiety be the individual's experience on a daily basis The range of each measurement score was 20-80. Higher scores indicate greater anxiety.

    Change from Baseline State-Trait Anxiety Inventory at Day20

  • Anxiety

    The State-Trait Anxiety Inventory, STAI. It includes two types of anxiety. The state anxiety is considered to be individual's temporary perception toward fear, nervousness, discomfort etc. and the trait anxiety be the individual's experience on a daily basis The range of each measurement score was 20-80. Higher scores indicate greater anxiety.

    Change from Baseline State-Trait Anxiety Inventory at Day32

Secondary Outcomes (25)

  • Intestinal Transit Time

    Change from Baseline Bristol Stool Form Scale at Day 2

  • Intestinal Transit Time

    Change from Baseline Bristol Stool Form Scale at Day 3

  • Intestinal Transit Time

    Change from Baseline Bristol Stool Form Scale at Day 4

  • Intestinal Transit Time

    Change from Baseline Bristol Stool Form Scale at Day 5

  • Intestinal Transit Time

    Change from Baseline Bristol Stool Form Scale at Day 6

  • +20 more secondary outcomes

Study Arms (2)

A Group

EXPERIMENTAL
Other: Kombucha

B Group

OTHER

Waiting list

Other: Kombucha

Interventions

KombuchaOTHER

Kombucha is a fermented tea drink that originated in ancient Chinese civilization. It is made by combining tea, juice, and SCOBY (Symbiotic Culture of Bacteria and Yeast). During the fermentation process, the yeast in the SCOBY breaks down the sugar in the tea releasing friendly probiotic bacteria, giving kombucha its fizzy body and its sweet and tangy taste.

A GroupB Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Stage 0-III Breast Cancer
  • No any cancer treatment in the following year
  • Perceived emotional distress and poor sleep quality
  • Agree to follow the protocol of this study

You may not qualify if:

  • Stage IV Breast Cancer
  • Pregnant women
  • Abnormal liver, kidney, gastric, internal , immune, sleep disorder, metabolic, psychic functions and need to take the prescription medications or medical treatments regularly
  • could not follow the protocol of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming University

Taipei, 11221, Taiwan

RECRUITING

MeSH Terms

Interventions

Kombucha Tea

Intervention Hierarchy (Ancestors)

TeaPlant PreparationsBiological ProductsComplex MixturesFermented BeveragesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsFood and Beverages

Study Officials

  • I-Ching Hou, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Ching Hou, PhD

CONTACT

886-2-28267000evidta@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 8, 2023

Study Start

December 12, 2022

Primary Completion

December 12, 2024

Study Completion

December 12, 2025

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

TW(1)