NCT07021378Completed
Tolerance to Immunomodulatory Nutritional Therapy in Oncology Patients Undergoing Chemotherapy and Radiotherapy
Source: ClinicalTrials.gov · Last updated 15 Jun 2025
Brief summary (registry, in English)
The importance of nutritional support is established in some types of neoplasms, especially those involving the digestive tract. Recently, nutritional supplements containing substances with proposed immunomodulatory action have been developed. It is still unclear whether the use of immunomodulatory supplements can reduce the occurrence of treatment-related toxicities in oncology, such as radiodermatitis and mucositis. The aim of this study is to investigate whether the use of supplements with immunomodulatory action could reduce the occurrence of cutaneous and mucosal toxicities in oncology treatment, such as radiodermatitis and diarrhea.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 31 Mar 2025
- Start date
- 23 Mar 2022
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- D'Or Institute for Research and Education
- NCT number
- NCT07021378
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 23 Mar 2022 to the primary completion date, 31 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiotherapy in the same field where the current treatment will be performed.
Other illness
- Metastatic disease;
- Conditions that compromise the ability to ingest or absorb nutritional therapy, such as inflammatory bowel disease, intestinal perforation, intestinal obstruction, or uncontrolled lower gastrointestinal bleeding;
Other
- Inability to intake food orally;
Who the study is looking for
- Histological confirmation of carcinoma from one of the following two primary sites: breast (Cohort A); anal canal (Cohort B);
- Localized disease, stages I-III, according to the 8th edition of TNM classification;
- Indication for neoadjuvant TC-HP treatment, surgery, and adjuvant radiotherapy for breast cancer (Cohort A) or definitive chemoradiotherapy for anal canal cancer (Cohort B).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto D'or de Pesquisa e Ensino Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.