ConstipationNCT05906186
Study Intestinal Complaints During Chemotherapy.
An observational study of Constipation, run by Spaarne Gasthuis.
Trial summary
Study intestinal complaints during chemotherapy. A prospective study into intestinal complaints in patients undergoing chemotherapy treatment. A pre and post implementation design is used to establish if eating two kiwi fruits per day can prevent constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- kiwifruit
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 May 2024
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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
Study population: For this study adult patients undergoing their first neo adjuvant or adjuvant chemotherapy are included.
Who may be able to join
- First chemotherapy/cytostatics treatment
- Neo-adjuvant or adjuvant treatment
- Performance status World Health Organization (WHO) 0-1
- Age 18+
- Written informed consent
- Command of the Dutch language
Who cannot join
- Kiwi allergy
- Patients using standard laxatives prior to the first chemotherapy/cytostatic treatment.
- Patients with a history of bowel resection
- Patients with stoma
Trial locations and contacts
No sites are listed yet.
About this study
Study intestinal complaints during chemotherapy. A prospective study into intestinal complaints in patients undergoing chemotherapy treatment. A pre and post implementation design is used to establish if eating two kiwi fruits per day can prevent constipation.
Read the detailed description
The Medical Research Involving Human Subjects Act (WMO) does not apply to this research. Nonetheless it will be conducted according to the principals of Good Clinical Practice (GCP), privacy legislation (AVG) and Medical Treatment Agreement Act (WGBO). The consumption of eating two kiwi's a day can be seen as a slight variation on standard advice with regards to a healthy diet. Maintaining a diary may take some time from the participant but at the same time is of use during follow up visits where side effects, including the occurrence of constipation are discussed. The The study is approved by the Advisory Committee on Local Feasibility (ACLU) of the Spaarne Gasthuis.
- Conditions
- Constipation
- Being tested
- kiwifruit
- Keywords
- Kiwifruit, Chemotherapy
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kiwifruitBehavioural
eating two kiwifruits a day
| Study group | Role | What they receive |
|---|---|---|
| Pre-test | Standard care: all patients who are starting their first (neo adjuvant or adjuvant) treatment with chemotherapy visit the nurse practitioner. Site effects like constipation will be discussed and the prescription of laxatives is standard care. Participants will keep a stool pattern diary during two months using the Bristol Stool Scale (BSS). During follow up the occurrence of side effect, such as nausea, diarrhea and constipation is assessed. | |
| Post-test | After the first four months (pre-test phase) of the study, nurse practitioners are asked, as lifestyle advice, to eat two kiwis per day instead of two pieces of fruit. A similar group of patients undergoing their first (neo-adjuvant or adjuvant) chemotherapy treatment are approached with a request to participate in the study. Participants keep a diary of defecation patterns for two months using the Bristol Stool Scale (BSS). During follow-up, the occurrence of side effects such as nausea, diarrhea and constipation will be assessed. Receives: Behavioral: kiwifruit |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. How common are constipation symptoms in patients undergoing chemotherapy treatment?
Measured: 1 year
Secondary outcomes (2)
2. Does the use of laxatives decrease when consuming two kiwi's a day?
Measured: 1 year
3. Which interventions against constipation do patients experience as the most comfortable?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906186
- Sponsor's protocol ID
- 2023.0026
- Status last verified
- Jun 2023
- First submitted
- 7 Jun 2023
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Intestinal Complaints During Chemotherapy.
- ClinicalTrials.gov ID
- NCT05906186
- Acronym / sponsor ID
- 2023.0026
- Conditions
- Constipation
- Keywords
- Kiwifruit, Chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 15 Jun 2023 (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.
Study intestinal complaints during chemotherapy. A prospective study into intestinal complaints in patients undergoing chemotherapy treatment. A pre and post implementation design is used to establish if eating two kiwi fruits per day can prevent constipation.
Detailed description
The Medical Research Involving Human Subjects Act (WMO) does not apply to this research. Nonetheless it will be conducted according to the principals of Good Clinical Practice (GCP), privacy legislation (AVG) and Medical Treatment Agreement Act (WGBO). The consumption of eating two kiwi's a day can be seen as a slight variation on standard advice with regards to a healthy diet. Maintaining a diary may take some time from the participant but at the same time is of use during follow up visits where side effects, including the occurrence of constipation are discussed. The The study is approved by the Advisory Committee on Local Feasibility (ACLU) of the Spaarne Gasthuis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-test | – | –Standard care: all patients who are starting their first (neo adjuvant or adjuvant) treatment with chemotherapy visit the nurse practitioner. Site effects like constipation will be discussed and the prescription of laxatives is standard care. Participants will keep a stool pattern diary during two months using the Bristol Stool Scale (BSS). During follow up the occurrence of side effect, such as nausea, diarrhea and constipation is assessed. |
| Post-test | – | Behavioral: kiwifruitAfter the first four months (pre-test phase) of the study, nurse practitioners are asked, as lifestyle advice, to eat two kiwis per day instead of two pieces of fruit. A similar group of patients undergoing their first (neo-adjuvant or adjuvant) chemotherapy treatment are approached with a request to participate in the study. Participants keep a diary of defecation patterns for two months using the Bristol Stool Scale (BSS). During follow-up, the occurrence of side effects such as nausea, diarrhea and constipation will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study adult patients undergoing their first neo adjuvant or adjuvant chemotherapy are included.
Key inclusion criteria (6 listed)
- First chemotherapy/cytostatics treatment
- Neo-adjuvant or adjuvant treatment
- Performance status World Health Organization (WHO) 0-1
- Age 18+
- Written informed consent
Key exclusion criteria (4 listed)
- Kiwi allergy
- Patients using standard laxatives prior to the first chemotherapy/cytostatic treatment.
- Patients with a history of bowel resection
- Patients with stoma
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 |
|---|---|---|
| kiwifruiteating two kiwifruits a day | Behavioural | Post-test |
Primary outcome
1. How common are constipation symptoms in patients undergoing chemotherapy treatment?
Time frame: 1 year
2 secondary outcomes
2. Does the use of laxatives decrease when consuming two kiwi's a day?
Time frame: 1 year
3. Which interventions against constipation do patients experience as the most comfortable?
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Spaarne Gasthuis.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nienke de Beer, MSc (+31232240000, Ndebeer@spaarnegasthuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. How common are constipation symptoms in patients undergoing chemotherapy treatment? (time frame: 1 year). 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 15 Jun 2023.