NCT05717972 — Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors · CancerIndex

Clinical trial · Interventional

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

NCT05717972CI-TRIAL-00063765unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Distress, Emotional	—	UNRESOLVED	—
Sleep	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Kombucha	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
A Group
interventionNames
1. Other: Kombucha
type
OTHER
label
B Group
description
Waiting list
interventionNames
1. Other: Kombucha

Primary outcomes (4)

measure
Sleep Quality Index
timeFrame
Change from Baseline Sleep Quality Index at Day 20
description
The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 40 Years
Maximum age: 60 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Dec 12, 2022
Primary completion: Dec 12, 2024
Completion: Dec 12, 2025
First posted: Feb 8, 2023
Last update posted: Feb 8, 2023
Enrollment: 60 (estimated)
Lead sponsor: National Yang Ming Chiao Tung University OTHER

Data updated 22 days agoSource updated Feb 8, 2023source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
Taiwan	1	1

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.

Secondary outcomes (25)

measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 2
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 3
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 4
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 5
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 6
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 7
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 8
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 9
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 10
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 11
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 12
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 13
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 14
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 15
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 16
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 17
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 18
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 19
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 20
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 21
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 22
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 23
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 24
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 25
description
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.
measure
Intestinal Transit Time
timeFrame
Change from Baseline Bristol Stool Form Scale at Day 26
description
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.