Clinical trial NCT07023042: Kinesio-Taping vs. Usual Care for Malignant Bowel Obstruction With Ascites: A Randomized Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Bowel Obstruction
Ascites
Advanced Cancer
Keywords: Kinesio taping
Palliative care
Adjuvant therapy
Non-pharmacological intervention
Malignant Bowel Obsruction
Advanced Cancer
dmonton Symptom Assessment System
Symptom management
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Malignant bowel obstruction (MBO) with ascites is a common and severe complication among patients with advanced intra-abdominal or retroperitoneal malignancies. Standard management of MBO includes surgery, medical therapy (such as antiemetics, corticosteroids, or octreotide), and decompression using nasogastric tubes. However, many patients continue to experience distressing symptoms-such as persistent abdominal pain, nausea, vomiting, and bloating-despite aggressive treatment. These symptoms contribute to significant discomfort, reduced quality of life, and poor prognosis in patients with advanced cancer.

Kinesio-taping is an elastic, waterproof adhesive strip designed to mimic the properties of skin and soft tissue. It is widely used in rehabilitation and sports medicine for its potential to reduce pain, improve circulation, and provide mechanical support. The mechanism is thought to involve stimulation of cutaneous mechanoreceptors, improved lymphatic drainage, and modulation of muscle activity. While Kinesio-taping has shown benefits in managing lymphedema and musculoskeletal pain, its application in patients with MBO and ascites is not well-studied. Existing evidence is mostly limited to case reports and studies in other patient populations.

This randomized controlled trial aims to evaluate whether abdominal Kinesio-taping, in addition to standard care, can safely and effectively reduce symptom burden in adult cancer patients with MBO and ascites whose symptoms persist after conventional treatment. The trial is conducted at a single tertiary medical center. Eligible patients are randomized in a 1:1 ratio to either the intervention group (standard care plus Kinesio-taping) or the control group (standard care alone). The Kinesio-taping protocol uses an FDA-approved medical-grade tape (NKH-50R) and follows a standardized application technique. Prior to the first application, all patients in the intervention group undergo a skin sensitivity test. The tape is applied in a circular pattern around the umbilicus, with specific attention to avoiding tumor sites and open wounds, and removed using techniques designed to minimize skin trauma.

All participants continue to receive standard care for MBO, including pain management, fluid and electrolyte support, and palliative interventions as appropriate. Data are collected at baseline and three days after intervention. The primary outcome is change in symptom severity, measured by the Edmonton Symptom Assessment System modified for ascites (ESAS:AM). Secondary outcomes include changes in abdominal girth and dosage of analgesic medications. Safety is monitored through daily assessment for skin reactions or other adverse effects.

This study is designed with rigorous attention to ethical conduct and data privacy. All participant information is de-identified and securely stored, and only authorized research personnel have access. The anticipated sample size is 40 participants, with randomization stratified by baseline symptom severity to ensure balanced allocation. Data will be analyzed using appropriate statistical methods, including independent t-tests and generalized estimating equations for repeated measures.

If proven effective and safe, Kinesio-taping could offer a non-invasive, low-cost, and easily administered adjunct to standard palliative care for patients with malignant bowel obstruction and ascites, potentially empowering both patients and caregivers with a new option for symptom relief.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in symptom severity score using the Edmonton Symptom Assessment System-Ascites Modification (ESAS:AM)
timeFrame: Baseline and 3 days after intervention
Secondary outcomes:
measure: Change in abdominal girth
timeFrame: Baseline and 3 days after intervention
measure: Change in analgesic medication use
timeFrame: Baseline and 3 days after intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: