Constipation Drug InducedNCT07007468
Prevention of Constipation in Cancer Patients
A study testing Abdominal Massage in people with Constipation Drug Induced, run by Can Lafci at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation Drug Induced
- What is being tested?
- Abdominal Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2025to 14 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Receiving chemotherapy for breast 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,
Show all 10Show fewer
- 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
Who cannot join
- Patients with stool type 3, 4, 5, 6 and 7 points according to the Bristol Stool Scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
Istanbul, Marmara, 34381
About this study
Official title: The Effect of Abdominal Massage in Prevention of Chemotherapy-Induced Constipation
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.
Read the 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
- Being tested
- Abdominal Massage
- Keywords
- chemotherapy, constipation, massage
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage Group | Experimental | 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). Receives: Other: Abdominal Massage |
| Control Group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
This form was created by the researcher by reviewing the literature. The form included a total of 39 questions about the patient's current disease, descriptive characteristics, socio-demographic characteristics, chemotherapy cycle and regimen, medication use that may cause constipation, performance status score, appetite status, amount of fluid consumed daily, physical activity status, and food group consumed in the last week.
Measured: one day
Bristol Fecal Consistency Scale
The Bristol Stool Consistency Scale was developed by Lewis et al. The form of the stool varies according to the transit time through the intestine. With this scale, the stool form is evaluated over seven different stool types. In the scale, 1 and 2 points are evaluated as "hard stool-constipation", 3, 4 and 5 points as "normal stool", 6 and 7 points as "soft-watery stool (diarrhea)".
Measured: five days
Constipation Severity Scale
The Constipation Severity Scale (CSS) was developed by Varma et al. in 2008. Its Turkish validity and reliability was performed by Kaya. The scale consists of 16 items to determine the frequency and intensity of defecation and difficulty/difficulty during defecation. The scale has 3 sub-dimensions: "fecal obstruction", "laziness of the large intestine" and "pain". The score that can be obtained from the fecal obstruction sub-dimension is between 0-28, the score that can be obtained from the large intestine sub-dimension is between 0-29, and the score that can be obtained from the pain sub-dimension is between 0-16. The lowest total score that can be obtained from the scale is 0 and the highest score is 73. A high score on the scale indicates that the symptoms are serious. Cronbach's alpha value of the original scale: 0.88-0.91; Cronbach's alpha of the Turkish scale: 0.92-0.93.
Measured: two days
Constipation Quality of Life Scale
The scale, which was developed by Marquis et al. (2005), and validated and reliably analyzed in Turkish (2015), consists of a total of 28 items. This five-point Likert scale consists of 4 sections: 'Anxiety or Worry' (11 items), 'Physical Discomfort' (4 items), 'Psychosocial Discomfort' (8 items) and 'Satisfaction' (5 items). In the Constipation Quality of Life Scale, questions 18, 25, 26, 27 and 28 are reverse items and are calculated by reversing them. A minimum score of 28 and a maximum score of 140 is obtained from this scale. The Cronbach's alpha value of the scale is 0.96. A low total score indicates a high quality of life.
Measured: two days
Patient Monitoring and Control Form
It is a simple, easy-to-implement, practical form created by the researcher to monitor the daily nutrients consumed by the patients, to monitor whether abdominal massage is performed, and to ensure that the Bristol Stool Consistency Scale (Appendix-2) evaluations are followed up by the patients and their families.
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start8 Jun 2025
- Primary completion14 Jul 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation Drug InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups with a conventional therapy control group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Lafci
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Sponsor-investigator, Can Lafci, Marmara University
- Investigators
- Can LAFÇI, PhD(c), Study director, İSTANBUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007468
- Sponsor's protocol ID
- İUC-FNHF-CL-01
- Status last verified
- Aug 2026
- First submitted
- 28 May 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abdominal Massage in Prevention of Chemotherapy-Induced Constipation
- ClinicalTrials.gov ID
- NCT07007468
- Acronym / sponsor ID
- İUC-FNHF-CL-01
- Conditions
- Constipation Drug Induced
- Keywords
- chemotherapy, constipation, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Can LafciUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 8 Jun 2025 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups with a conventional therapy control group
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage Group | Experimental | Other: Abdominal MassagePatients 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). |
| Control Group | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or older,
- Receiving chemotherapy for breast 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,
Key exclusion criteria (1 listed)
- Patients with stool type 3, 4, 5, 6 and 7 points according to the Bristol Stool Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal MassageAbdominal 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. | Other | Abdominal Massage Group |
Primary outcome
Patient Identification Form
Time frame: one day
This form was created by the researcher by reviewing the literature. The form included a total of 39 questions about the patient's current disease, descriptive characteristics, socio-demographic characteristics, chemotherapy cycle and regimen, medication use that may cause constipation, performance status score, appetite status, amount of fluid consumed daily, physical activity status, and food group consumed in the last week.
Bristol Fecal Consistency Scale
Time frame: five days
The Bristol Stool Consistency Scale was developed by Lewis et al. The form of the stool varies according to the transit time through the intestine. With this scale, the stool form is evaluated over seven different stool types. In the scale, 1 and 2 points are evaluated as "hard stool-constipation", 3, 4 and 5 points as "normal stool", 6 and 7 points as "soft-watery stool (diarrhea)".
Constipation Severity Scale
Time frame: two days
The Constipation Severity Scale (CSS) was developed by Varma et al. in 2008. Its Turkish validity and reliability was performed by Kaya. The scale consists of 16 items to determine the frequency and intensity of defecation and difficulty/difficulty during defecation. The scale has 3 sub-dimensions: "fecal obstruction", "laziness of the large intestine" and "pain". The score that can be obtained from the fecal obstruction sub-dimension is between 0-28, the score that can be obtained from the large intestine sub-dimension is between 0-29, and the score that can be obtained from the pain sub-dimension is between 0-16. The lowest total score that can be obtained from the scale is 0 and the highest score is 73. A high score on the scale indicates that the symptoms are serious. Cronbach's alpha value of the original scale: 0.88-0.91; Cronbach's alpha of the Turkish scale: 0.92-0.93.
Constipation Quality of Life Scale
Time frame: two days
The scale, which was developed by Marquis et al. (2005), and validated and reliably analyzed in Turkish (2015), consists of a total of 28 items. This five-point Likert scale consists of 4 sections: 'Anxiety or Worry' (11 items), 'Physical Discomfort' (4 items), 'Psychosocial Discomfort' (8 items) and 'Satisfaction' (5 items). In the Constipation Quality of Life Scale, questions 18, 25, 26, 27 and 28 are reverse items and are calculated by reversing them. A minimum score of 28 and a maximum score of 140 is obtained from this scale. The Cronbach's alpha value of the scale is 0.96. A low total score indicates a high quality of life.
Patient Monitoring and Control Form
Time frame: five days
It is a simple, easy-to-implement, practical form created by the researcher to monitor the daily nutrients consumed by the patients, to monitor whether abdominal massage is performed, and to ensure that the Bristol Stool Consistency Scale (Appendix-2) evaluations are followed up by the patients and their families.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Can LAFÇI, PhD(c) study director
İSTANBUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Massage in people with Constipation Drug Induced, run by Can Lafci at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: one day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.