NCT07021378

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: D'Or Institute for Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Nutritional Deficiency
• Breast Cancer
• Anal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-23
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

2 sites across 1 country: Brazil