Study Intestinal Complaints During Chemotherapy.

NCT05906186 | Unknown

• 1 other identifier: 2023.0026
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation

Keywords

Kiwifruit; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 1. How common are constipation symptoms in patients undergoing chemotherapy treatment?

  1 year

Secondary Outcomes (2)

• 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

Study Arms (2)

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

Interventions

kiwifruit BEHAVIORAL

eating two kiwifruits a day

Post-test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Spaarne Gasthuis: lead

MeSH Terms

Conditions

Constipation

Interventions

alcohol acyltransferase, Actinidia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nienke de Beer, MSc

CONTACT

+31232240000; Ndebeer@spaarnegasthuis.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 30, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share