Clinical trial NCT07007468: Prevention of Constipation in Cancer Patients
Official title: The Effect of Abdominal Massage in Prevention of Chemotherapy-Induced Constipation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Constipation Drug Induced
Keywords: chemotherapy
constipation
massage
Lead sponsor: Marmara University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2025-06-05
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with a conventional therapy control group
Primary purpose: PREVENTION

Brief summary: Constipation is the third most common symptom in patients undergoing chemotherapy, with an incidence rate ranging from 31% to 90%. Despite its high prevalence and adverse effects on patients, constipation is often not reported by patients and is not frequently monitored by nurses, resulting in delays in treatment and care. Prolonged constipation can lead to health problems such as fecal impaction/obstruction, hemorrhoids, rectal pain, and intestinal perforation, thereby reducing patients' quality of life. Additionally, increased severity of constipation in cancer patients may lead to the interruption or complete cessation of chemotherapy. Therefore, it is essential to monitor and assess patients for the risk of developing constipation and to implement an effective nursing care protocol.

Abdominal massage is an approach that increases peristalsis, i.e., digestive system movement, by altering intra-abdominal pressure, thereby reducing the severity of constipation.

Detailed description: Cancer is one of the most important health problems in our country and in the world. According to the Global Cancer Observation Data (GLOBOCAN), 9.7 million people lost their lives due to cancer in 2022. There are many methods such as chemotherapy, radiotherapy and surgical treatment in the treatment of cancer. Chemotherapy is the most commonly used of these systemic treatment approaches. Chemotherapy-related gastrointestinal symptoms such as constipation, diarrhea, bloating, incontinence, flatulence and abdominal distension are observed in patients. Constipation is the third most symptom in patients receiving chemotherapy, with a prevalence of 40% to 90%.

Although constipation is common and affects patients negatively, it is not expressed by patients and is not frequently followed up by nurses, resulting in disruptions in the treatment and care process. Prolongation of the constipation process health problems such as fecal impaction / obstruction, hemorrhoids, rectal pain and intestinal perforation and decreases the quality of life of the patients. In addition, increased severity of constipation in cancer patients leads to interruption or complete termination of chemotherapy. Therefore, patients be monitored and evaluated in terms of the risk of constipation development and an effective nursing care protocol should be implemented.

Pharmacologic, non-pharmacologic and surgical methods are used to prevent constipation. Pharmacologic and surgical approaches are quite costly. In the non-pharmacological approach; methods such as increasing fiber food and water consumption, regular exercise, abdominal massage are used. Abdominal massage is a non-invasive nonpharmacologic approach that increases digestive system movement by changing intra-abdominal pressure, reduces the severity of constipation, is safe and has no side effects, and can be applied by nurses with independent decision-making authority and educator role.

This thesis was planned to evaluate "The Effect of Abdominal Massage in the Prevention of Chemotherapy Associated Constipation".

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* Receiving chemotherapy for breast cancer or lung cancer that causes constipation
* Patients who received at least one cycle of chemotherapy and experienced chemotherapy-associated constipation within five days of treatment (stool type 1 or 2 according to the Bristol Stool Scale)
* Volunteers who are willing to participate in the research, can communicate, and can read and write,
* Without psychiatric illness and abdominal obstruction,
* No mass in the abdominal region was detected,
* No intestinal bleeding,
* No history of radiation therapy to the abdominal region,
* No surgical procedures in the abdominal region,
* Patients without intra-abdominal infection, inflammatory bowel disease and irritable bowel syndrome will be included

Exclusion Criteria:

* Patients with stool type 3, 4, 5, 6 and 7 points according to the Bristol Stool Scale

Primary outcomes:
measure: Patient Identification Form
timeFrame: one day
measure: Bristol Fecal Consistency Scale
timeFrame: five days
measure: Constipation Severity Scale
timeFrame: two days
measure: Constipation Quality of Life Scale
timeFrame: two days
measure: Patient Monitoring and Control Form
timeFrame: five days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
state: Marmara
Study officials:
affiliation: İSTANBUL
name: Can LAFÇI, PhD(c)
role: STUDY_DIRECTOR
References: