Study Intestinal Complaints During Chemotherapy.

Not yet recruiting

• Conditions: Constipation
• Interventions: Behavioral: kiwifruit

• Registration Number: NCT05906186
• Lead Sponsor: Spaarne Gasthuis

Brief 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.

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 Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Study Start: 2023-09-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. First chemotherapy/cytostatics treatment
2. Neo-adjuvant or adjuvant treatment
3. Performance status World Health Organization (WHO) 0-1
4. Age 18+
5. Written informed consent
6. Command of the Dutch language

Exclusion Criteria

1. Kiwi allergy
2. Patients using standard laxatives prior to the first chemotherapy/cytostatic treatment.
3. Patients with a history of bowel resection
4. Patients with stoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-test	kiwifruit	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.

Primary Outcome Measures

Name	Time	Method
1. How common are constipation symptoms in patients undergoing chemotherapy treatment?	1 year

Secondary Outcome Measures

Name	Time	Method
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