NCT07023042

Brief Summary

The goal of this clinical trial is to find out whether abdominal Kinesio-taping is a feasible and effective way to relieve symptoms in patients with malignant bowel obstruction and ascites who still have severe symptoms after surgery, medication, or nasogastric tube treatment. The main questions it aims to answer are:

  • Can abdominal Kinesio-taping reduce the severity of symptoms, such as abdominal pain, bloating, and nausea, in these patients?
  • Is abdominal Kinesio-taping a safe and practical treatment option for this patient group? Participants in this study are adults with cancer who have been diagnosed with malignant bowel obstruction and ascites, and whose symptoms have not improved after standard medical treatments. People who are allergic to tape, have abdominal wounds, are pregnant, or are unable to provide consent will not be included. Participants will be randomly assigned to one of two groups:
  • The Kinesio-taping group will receive standard care for malignant bowel obstruction plus abdominal Kinesio-taping, applied by trained professionals using a standardized procedure.
  • The control group will receive standard care only. The main outcomes measured will be changes in symptom severity using the Edmonton Symptom Assessment System (ESAS) modified for ascites, as well as abdominal girth and pain medication use. Symptoms and side effects will be closely monitored to ensure safety. The information from this study may help determine whether Kinesio-taping can be an additional, safe, and effective option for managing symptoms in patients with advanced cancer who have malignant bowel obstruction and ascites.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress69%
Jun 2025Oct 2026

First Submitted

Initial submission to the registry

June 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

June 8, 2025

Last Update Submit

June 17, 2025

Conditions

Keywords

Kinesio tapingPalliative careAdjuvant therapyNon-pharmacological interventionMalignant Bowel ObsructionAdvanced Cancerdmonton Symptom Assessment SystemSymptom management

Outcome Measures

Primary Outcomes (1)

  • Change in symptom severity score using the Edmonton Symptom Assessment System-Ascites Modification (ESAS:AM)

    Symptom severity will be measured using the ESAS:AM, which includes 11 items evaluating abdominal pain, bloating, nausea, and other symptoms related to malignant bowel obstruction and ascites. Each item is scored on an 11-point numeric rating scale (0-10), and the average score will be used for analysis. The primary outcome is the change in average symptom severity score from baseline to Day 3 after intervention.

    Baseline and 3 days after intervention

Secondary Outcomes (2)

  • Change in abdominal girth

    Baseline and 3 days after intervention

  • Change in analgesic medication use

    Baseline and 3 days after intervention

Study Arms (2)

Kinesio taping Group

EXPERIMENTAL

Participants receive standard care for malignant bowel obstruction and ascites, plus abdominal Kinesio-taping applied by trained professionals according to a standardized protocol.

Other: Abdominal Kinesio taping

Control Group

ACTIVE COMPARATOR

Participants receive standard care for malignant bowel obstruction and ascites without Kinesio taping.

Other: Standard Care Arm

Interventions

Application of medical-grade Kinesio tape (NKH-50R) to the abdomen using a standardized circular technique, in addition to standard care for malignant bowel obstruction and ascites. Tape is applied by trained professionals after a skin sensitivity test and changed every three days or as needed. The procedure avoids open wounds and tumor sites. Participants and caregivers are educated on tape care and removal.

Also known as: Kinesio taping, KT, Kinesiotaping, Kinesiology taping, Kinesiology tape, K-active tape
Kinesio taping Group

Standard palliative care for malignant bowel obstruction and ascites, including symptom management, nutritional support, and medical treatment according to institutional protocols.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 years or older.
  • Histologically confirmed intra-abdominal or retroperitoneal malignancy.
  • Diagnosis of malignant bowel obstruction with ascites located below the ligament of Treitz.
  • Persistent severe symptoms (such as pain, bloating, nausea, vomiting) after surgery, medication, or nasogastric tube treatment.
  • Able to communicate in Mandarin or Taiwanese.
  • Capable of providing informed consent.

You may not qualify if:

  • Presence of significant abdominal wounds that preclude application of Kinesio tape.
  • Known allergy or hypersensitivity to Kinesio tape.
  • Pregnancy.
  • Lack of decision-making capacity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100225, Taiwan

RECRUITING

MeSH Terms

Conditions

Ascites

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

HSIEN-LIANG HUANG, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking is used in this study because the nature of the intervention (abdominal Kinesio-taping) does not allow for blinding of participants or care providers.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel assignment, randomized controlled trial with two arms: an intervention group receiving abdominal Kinesio-taping in addition to standard care, and a control group receiving standard care only. Participants are randomly assigned (1:1) to one of the two groups. No crossover or sequential treatment is planned. All outcome measures are assessed at baseline and three days after intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2025

First Posted

June 15, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

June 6, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect patient privacy and comply with local regulations

Locations