Study Intestinal Complaints During Chemotherapy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Behavioral: kiwifruit

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Nienke de Beer, MSc; Phone Number: +31232240000; Email: Ndebeer@spaarnegasthuis.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

For this study adult patients undergoing their first neo adjuvant or adjuvant chemotherapy are included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: kiwifruit; eating two kiwifruits a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Spaarne Gasthuis

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chemotherapy; Kiwifruit
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2023.0026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No