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NCT05906186 Clinical Trial

Study Intestinal Complaints During Chemotherapy.

Constipation Clinical Trial

Official title:
Study Intestinal Complaints During Chemotherapy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05906186
Other study ID # 2023.0026
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date May 30, 2024

Study information
Verified date June 2023
Source Spaarne Gasthuis
Contact Nienke de Beer, MSc
Phone +31232240000
Email Ndebeer@spaarnegasthuis.nl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date May 30, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• kiwifruit
eating two kiwifruits a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Spaarne Gasthuis

Outcome
Type Measure Description Time frame Safety issue
Primary 1. How common are constipation symptoms in patients undergoing chemotherapy treatment? 1 year
Secondary 2. Does the use of laxatives decrease when consuming two kiwi's a day? 1 year
Secondary 3. Which interventions against constipation do patients experience as the most comfortable? 1 year
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