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

Summary

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.

Conditions

• Nutritional Deficiency
• Breast Cancer
• Anal Cancer

Interventions

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.

DIETARY_SUPPLEMENT

Dietary Supplement

2 units of Impact oral supplement and 1 sachet of protein module once daily, starting 1 week before the initiation of radiotherapy (RT). During RT: 1 unit of Impact and 1 sachet of protein module daily, until 1 week before the end of RT. 2 units of Impact and 1 sachet of protein module daily until the end of treatment, starting from 1 week before the end of RT. Protein module: 13 g/day throughout the entire treatment period.

OTHER

Control Cohort A

Control cohort A: According to the institutional routine nutritional orientation

OTHER

Control cohort B

Control cohort B: According to the institutional routine nutritional orientation

Sponsors & Collaborators

• Nestle Health Science

  collaborator INDUSTRY

• D'Or Institute for Research and Education

  lead OTHER

Principal Investigators

• Camila M. V. Moniz, MD-PhD · PI

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-23

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Brazil

Study Locations