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

NCT07021378 | Completed

• 1 other identifier: 55651522.2.1001.0087
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adherence to the immunomodulatory nutritional supplementation regimen

  Percentage of adherence to the immunomodulatory nutritional supplementation regimen

  Up to 36 weeks

Study Arms (4)

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

EXPERIMENTAL

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

Dietary Supplement: Dietary Supplement

Control cohort A: Routine nutrition orientation

OTHER

Control Cohort A: According to the institutional routine nutritional orientation

Other: Control Cohort A

Cohort B: Patients with anal canal cancer with dietary supplementary

EXPERIMENTAL

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

Dietary Supplement: Dietary Supplement

Control cohort B: Routine nutrition orientation

OTHER

Control cohort B: According to the institutional routine nutritional orientation

Other: Control cohort B

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.

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

Control Cohort A OTHER

Control cohort A: According to the institutional routine nutritional orientation

Control cohort A: Routine nutrition orientation

Control cohort B OTHER

Control cohort B: According to the institutional routine nutritional orientation

Control cohort B: Routine nutrition orientation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead
• Nestle Health Science: collaborator

Study Sites (2)

Instituto D'or de Pesquisa e Ensino

São Paulo, São Paulo, 04.501-000, Brazil

Location

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (6)

• Colasanto JM, Prasad P, Nash MA, Decker RH, Wilson LD. Nutritional support of patients undergoing radiation therapy for head and neck cancer. Oncology (Williston Park). 2005 Mar;19(3):371-9; discussion 380-2, 387.

  PMID: 15828552 BACKGROUND

• Jordan T, Mastnak DM, Palamar N, Kozjek NR. Nutritional Therapy for Patients with Esophageal Cancer. Nutr Cancer. 2018 Jan;70(1):23-29. doi: 10.1080/01635581.2017.1374417. Epub 2017 Oct 10.

  PMID: 29016197 BACKGROUND

• Mileo AM, Nistico P, Miccadei S. Polyphenols: Immunomodulatory and Therapeutic Implication in Colorectal Cancer. Front Immunol. 2019 Apr 11;10:729. doi: 10.3389/fimmu.2019.00729. eCollection 2019.

  PMID: 31031748 BACKGROUND

• van Ramshorst MS, van der Voort A, van Werkhoven ED, Mandjes IA, Kemper I, Dezentje VO, Oving IM, Honkoop AH, Tick LW, van de Wouw AJ, Mandigers CM, van Warmerdam LJ, Wesseling J, Vrancken Peeters MT, Linn SC, Sonke GS; Dutch Breast Cancer Research Group (BOOG). Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Dec;19(12):1630-1640. doi: 10.1016/S1470-2045(18)30570-9. Epub 2018 Nov 6.

  PMID: 30413379 BACKGROUND

• Boisselier P, Kaminsky MC, Thezenas S, Gallocher O, Lavau-Denes S, Garcia-Ramirez M, Alfonsi M, Cupissol D, de Forges H, Janiszewski C, Geoffrois L, Sire C, Senesse P; Head and Neck Oncology and Radiotherapy Group (GORTEC). A double-blind phase III trial of immunomodulating nutritional formula during adjuvant chemoradiotherapy in head and neck cancer patients: IMPATOX. Am J Clin Nutr. 2020 Dec 10;112(6):1523-1531. doi: 10.1093/ajcn/nqaa227.

  PMID: 32936874 BACKGROUND

• Talvas J, Garrait G, Goncalves-Mendes N, Rouanet J, Vergnaud-Gauduchon J, Kwiatkowski F, Bachmann P, Bouteloup C, Bienvenu J, Vasson MP. Immunonutrition stimulates immune functions and antioxidant defense capacities of leukocytes in radiochemotherapy-treated head & neck and esophageal cancer patients: A double-blind randomized clinical trial. Clin Nutr. 2015 Oct;34(5):810-7. doi: 10.1016/j.clnu.2014.12.002. Epub 2014 Dec 9.

  PMID: 25575640 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Breast Neoplasms; Anus Neoplasms

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Camila M. V. Moniz, MD-PhD

  PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Principal Investigator

Model Details: Pilot study to evaluate the tolerance of imune nutritional supplement during cancer treatment.

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: June 15, 2025
• Study Start: March 23, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 4 years

Locations

BR (2)