Prevention of Constipation in Cancer Patients

NCT ID: NCT07007468

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-08
• Study Completion Date: 2025-12-31

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".

Conditions

Constipation Drug Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Abdominal Massage Group

Patients will be informed about the abdominal massage application; they will be informed that it should be applied twice a day for five days, 30 minutes after breakfast for 15 minutes and 30 minutes after dinner for 15 minutes. In order to make the massage application more understandable and effective, the abdominal massage application video to be created by the researcher will be shared with the patient and his/her family. After the fifth day of the Abdominal Massage application, patients will be evaluated for the last time with the Bristol Stool Consistency Scale (Appendix-2), Constipation Severity Scale (Appendix-3), Constipation Quality of Life Scale (Appendix-4) and Patient Monitoring and Control Form (Appendix-5).

Group Type: EXPERIMENTAL

Abdominal Massage

Intervention Type: OTHER

Abdominal massage is a massage technique performed with soft and rhythmic movements applied to the abdomen. Abdominal massage is an inexpensive, non-invasive, non-harmful, non-invasive method that can be applied by nurses for the treatment of constipation or by teaching the patient and his/her family. During the application of abdominal massage, effleurage (patting), abdominal effleurage , petrissage (kneading), abdominal petrissage maneuvers are applied.

Control Group

Patients who were determined to have constipation as a result of the Bristol Stool Consistency Scale evaluation and assigned to the control group by randomization method will first be administered the Patient Identification Form (Appendix-1), Constipation Severity Scale (Appendix-3), Constipation Quality of Life Scale (Appendix-4), and Patient Monitoring and Control Form (Appendix-5). The researcher will provide information about the "Patient Follow-up and Control Form (Appendix-5)" and the patients will be followed up regularly for five days.

After five days of follow-up, the patients will be evaluated with the Bristol Stool Consistency Scale (Appendix-2), Constipation Severity Scale (Appendix-3), Constipation Quality of Life Scale (Appendix-4) and Patient Follow-up and Control Form (Appendix-5).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Abdominal Massage

Abdominal massage is a massage technique performed with soft and rhythmic movements applied to the abdomen. Abdominal massage is an inexpensive, non-invasive, non-harmful, non-invasive method that can be applied by nurses for the treatment of constipation or by teaching the patient and his/her family. During the application of abdominal massage, effleurage (patting), abdominal effleurage , petrissage (kneading), abdominal petrissage maneuvers are applied.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Can LAFÇI, PhD(c)

Role: STUDY_DIRECTOR

İSTANBUL

Locations

Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing

Istanbul, Marmara, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

CAN LAFÇI, PhD(c)

Role: CONTACT

can.lafci@ogr.iuc.edu.tr

+90 546 931 90 39

Gülbeyaz CAN, PhD

Role: CONTACT

gulbeyaz@istanbul.edu.tr

+90 532 626 49 69

Facility Contacts

Can LAFÇI, PhD(c)

Role: primary

can.lafci@ogr.iuc.edu.tr

+90 546 931 90 39

Gülbeyaz CAN, PhD

Role: backup

gulbeyaz@istanbul.edu.tr

+90 532 626 49 69

Other Identifiers

İUC-FNHF-CL-01

Identifier Type: -

Identifier Source: org_study_id