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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05717972

Enrollment

Registered

2023-02-08

Start date

2022-12-12

Completion date

2025-12-12

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distress, Emotional, Sleep

Brief summary

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

Interventions

OTHERKombucha

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 60 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Sleep Quality Index	Change from Baseline Sleep Quality Index at Day 20	The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.
Anxiety	Change from Baseline State-Trait Anxiety Inventory at Day20	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.

Secondary

Measure	Time frame	Description
Intestinal Transit Time	Change from Baseline Bristol Stool Form Scale at Day 2	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7). Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.

Countries

Taiwan

Contacts

Primary ContactI-Ching Hou, PhD

evidta@gmail.com886-2-28267000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026