Kinesio-Taping vs. Usual Care for Malignant Bowel Obstruction With Ascites
KTMBO-RCT
Treatment of Kinesio-taping Versus Usual Care for Patients of Malignant Bowel Obstruction and Ascites With Persistent Severe Symptoms After Surgery, Medication and Nasogastric Tube: a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
1 active site
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 8, 2025
CompletedFirst Posted
Study publicly available on registry
June 15, 2025
CompletedStudy Start
First participant enrolled
June 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
June 22, 2025
June 1, 2025
12 months
June 8, 2025
June 17, 2025
Conditions
Keywords
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
EXPERIMENTALParticipants receive standard care for malignant bowel obstruction and ascites, plus abdominal Kinesio-taping applied by trained professionals according to a standardized protocol.
Control Group
ACTIVE COMPARATORParticipants receive standard care for malignant bowel obstruction and ascites without Kinesio taping.
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.
Standard palliative care for malignant bowel obstruction and ascites, including symptom management, nutritional support, and medical treatment according to institutional protocols.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- 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