Study Intestinal Complaints During Chemotherapy.

Sponsor

Spaarne Gasthuis (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05906186

Collaborator

(none)

Enrollment

8.9

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study Intestinal Complaints During Chemotherapy.

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 30, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

1. How common are constipation symptoms in patients undergoing chemotherapy treatment? [1 year]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Spaarne Gasthuis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Spaarne Gasthuis

ClinicalTrials.gov Identifier:

NCT05906186

Other Study ID Numbers:

2023.0026

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Spaarne Gasthuis

Kiwifruit

Chemotherapy

Additional relevant MeSH terms:

Constipation

Study Results

No Results Posted as of Jun 15, 2023