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Study Intestinal Complaints During Chemotherapy.

Study Intestinal Complaints During Chemotherapy.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05906186
Enrollment
80
Registered
2023-06-15
Start date
2023-09-01
Completion date
2024-05-30
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

Kiwifruit, Chemotherapy

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.

Interventions

BEHAVIORALkiwifruit

eating two kiwifruits a day

Sponsors

Spaarne Gasthuis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
1. How common are constipation symptoms in patients undergoing chemotherapy treatment?1 year

Secondary

MeasureTime 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

Contacts

Primary ContactNienke de Beer, MSc
Ndebeer@spaarnegasthuis.nl+31232240000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026