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Completed

NCT Number: NCT07021378

Tolerance to Immunomodulatory Nutritional Therapy in Oncology Patients Undergoing Chemotherapy and Radiotherapy

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.

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Key information

Conditions

Nutritional Deficiency Anal Cancer Anus Diseases Anus Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Rectal Diseases Rectal Neoplasms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto D'or de Pesquisa e Ensino, São Paulo, Brazil

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About this study

A prospective pilot study will be conducted to assess the use of immunomodulatory nutritional therapy in patients undergoing chemotherapy and radiotherapy for adjuvant or definitive cancer treatment at a service affiliated with Oncologia D'Or or at the Instituto do Câncer do Estado de São Paulo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Metastatic disease;
  • Inability to intake food orally;
  • 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;
  • Previous radiotherapy in the same field where the current treatment will be performed.

Treatment and study plan

Dietary Supplement

Dietary Supplement

Phase 1 (Neoadjuvant Chemotherapy):

Patients will receive 2 units of Impact oral supplement and 1 sachet of protein module daily, for 7 days prior to each chemotherapy cycle.

During the interval between the end of one cycle and 7 days before the next, 2 sachets of protein module per day will be maintained.

Phase 2 (Surgery):

2 units of Impact once daily, for 7 days prior to surgery.

Phase 3 (Radiotherapy):

2 units of Impact and 1 sachet of protein module daily, for 7 days prior to starting radiotherapy (RT), followed by 1 unit of Impact once daily throughout the course of RT.

Protein module: 13 g/day until the end of treatment.

Control Cohort A

Other

Control cohort A: According to the institutional routine nutritional orientation

Control cohort B

Other

Control cohort B: According to the institutional routine nutritional orientation

Primary outcomes

  1. Adherence to the immunomodulatory nutritional supplementation regimen

    Time frame: Up to 36 weeks

    Percentage of adherence to the immunomodulatory nutritional supplementation regimen

Sponsors and collaborators

Lead sponsor

D'Or Institute for Research and Education

Other

Collaborators

  • Nestle Health Science

Registry information

Acronym: NESTLE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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