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Effect of an Adapted Ice Cream on Cancer patients during Chemotherapy

Effect of Adapted Ice Cream ingestion on nutritional, inflammatory and oxidative stress indicators, incidence of oral mucositis and quality of life of individuals with Cancer undergoing Chemotherapy: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5dvnbqx
Enrollment
Unknown
Registered
2022-01-27
Start date
2022-05-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Hematologic Neoplasms. Leukemia. Lymphoma. Squamous Cell Carcinoma of Head and Neck. Esophageal Neoplasms. Facial Neoplasms. Mouth Neoplasms. Parathyroid Neoplasms. Thyroid Neoplasms. Tracheal Neoplasms

Interventions

This is a randomized, controlled, two-arm, single-blind clinical trial. Approximately 15 participants with hematologic cancer or head and neck cancer, ready to start chemotherapy, will receive the nut

Sponsors

Universidade Federal de Santa Catarina
Lead Sponsor
Hospital Universitário Polydoro Ernani de São Thiago
Collaborator

Eligibility

Age
19 Years to No maximum

Inclusion criteria

Inclusion criteria: individuals aged 19 years or over; both sexes; with recent clinical diagnosis of hematologic cancer or head and neck cancer and with indication to start chemotherapy treatment; in conditions of oral ingestion.

Exclusion criteria

Exclusion criteria: in palliative care; using statins and/or other anti-inflammatory drugs; who have undergone anticancer treatment in the 5 years prior to the survey; diagnosed with infectious contagious diseases; with indication for the use of enteral or parenteral nutrition; who have taken dietary supplements in the 6 months prior to the study; and who have an intolerance or allergy to any component of the adapted ice cream. Pregnant and lactating women will also be excluded.

Design outcomes

Primary

MeasureTime frame
Maintenance and/or improvement of nutritional status, assessed through body composition by bioelectrical impedance with phase angle on the 1st day of chemotherapy and on the 21st day after the start of chemotherapy (in the pilot study) or 9th week.

Secondary

MeasureTime frame
Incidence, duration and severity of oral mucositis, evaluated through clinical examination by a dental professional following the World Health Organization classification parameters for oral mucositis severity.;Changes in inflammatory and oxidative stress markers, assessed by taking blood from participants on day 1 of chemotherapy and on day 21 after chemotherapy initiation (in the pilot study) or week 9.;Changes in the Quality of Life pattern, assessed through the application of a structured and validated questionnaire for this population, on the 1st day of chemotherapy and on the 21st day after the start of chemotherapy (in the pilot study) or 9th week.

Countries

Brazil

Contacts

Public ContactBetina;Francilene Dambrós;Kunradi Vieira

Universidade Federal de Santa Catarina;Universidade Federal de Santa Catarina

betina.dambros@posgrad.ufsc.br;francilene.vieira@ufsc.br55 (48) 3721-6131;55 (48) 3721-6131

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 8, 2026