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

D'Or Institute for Research and Education

Status: Completed

Conditions: Anal Cancer; Breast Cancer; Nutritional Deficiency

Treatments: Other: Control cohort B; Other: Control Cohort A; Dietary Supplement: Dietary Supplement

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07021378

55651522.2.1001.0087

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histological confirmation of carcinoma from one of the following two primary sites: breast (Cohort A); anal canal (Cohort B);
2. Localized disease, stages I-III, according to the 8th edition of TNM classification;
3. 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

1. Metastatic disease;
2. Inability to intake food orally;
3. 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;
4. Previous radiotherapy in the same field where the current treatment will be performed.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Cohort A: patients with HER2-positive breast cancer with dietary supplementary

Experimental group

Description:

Supplementation with impact (Nestlé) and sachets to ingest during the neoadjuvant period, weeks after surgery, and adjuvant treatment.

Treatment:

Dietary Supplement: Dietary Supplement

Dietary Supplement: Dietary Supplement

Control cohort A: Routine nutrition orientation

Other group

Description:

Control Cohort A: According to the institutional routine nutritional orientation

Treatment:

Other: Control Cohort A

Cohort B: Patients with anal canal cancer with dietary supplementary

Experimental group

Description:

Impact supplement (Nestlé) and sachets of the supplement to ingest during chemotherapy and radiotherapy

Treatment:

Dietary Supplement: Dietary Supplement

Dietary Supplement: Dietary Supplement

Control cohort B: Routine nutrition orientation

Other group

Description:

Control cohort B: According to the institutional routine nutritional orientation

Treatment:

Other: Control cohort B