Study Intestinal Complaints During Chemotherapy.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study Intestinal Complaints During Chemotherapy.

Conditions
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Constipation

Intervention / Treatment
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* Behavioral: kiwifruit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Kiwi allergy Patients using standard laxatives prior to the first chemotherapy/cytostatic treatment. Patients with a history of bowel resection Patients with stoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-test<br>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<br>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. | Behavioral: kiwifruit<br>* eating two kiwifruits a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. How common are constipation symptoms in patients undergoing chemotherapy treatment? |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Does the use of laxatives decrease when consuming two kiwi's a day? |  | 1 year | 
| 3. Which interventions against constipation do patients experience as the most comfortable? |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kiwifruit, Chemotherapy