AzTrials
AzTrials

Nutritional DeficiencyNESTLENCT07021378

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

A study testing Dietary Supplement in people with Nutritional Deficiency and Breast Cancer, run by D'Or Institute for Research and Education at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nutritional Deficiency, Breast Cancer, Anal Cancer
What is being tested?
Dietary Supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
2 sitesBrazil
Study dates
23 Mar 2022to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Instituto D'or de Pesquisa e Ensino

    São Paulo, São Paulo, 04.501-000

  • Instituto do Câncer do Estado de São Paulo

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

About this study

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.

Read the 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.

Being tested
Dietary Supplement, Control Cohort A, Control cohort B
Medical subject headings
Malnutrition, Breast Neoplasms, Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary SupplementDietary 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 SupplementDietary 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.

  • Control Cohort AOther

    Control cohort A: According to the institutional routine nutritional orientation

  • Control cohort BOther

    Control cohort B: According to the institutional routine nutritional orientation

Study groups in NCT07021378
Study groupRoleWhat they receive
Cohort A: patients with HER2-positive breast cancer with dietary supplementaryExperimentalSupplementation with impact (Nestlé) and sachets to ingest during the neoadjuvant period, weeks after surgery, and adjuvant treatment.
Receives: Dietary Supplement: Dietary Supplement
Control cohort A: Routine nutrition orientationOtherControl Cohort A: According to the institutional routine nutritional orientation
Receives: Other: Control Cohort A
Cohort B: Patients with anal canal cancer with dietary supplementaryExperimentalImpact supplement (Nestlé) and sachets of the supplement to ingest during chemotherapy and radiotherapy
Receives: Dietary Supplement: Dietary Supplement
Control cohort B: Routine nutrition orientationOtherControl cohort B: According to the institutional routine nutritional orientation
Receives: Other: Control cohort B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to the immunomodulatory nutritional supplementation regimen

    Percentage of adherence to the immunomodulatory nutritional supplementation regimen

    Measured: Up to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study start23 Mar 2022
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Model description
Pilot study to evaluate the tolerance of imune nutritional supplement during cancer treatment.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021378
Sponsor's protocol ID
55651522.2.1001.0087
Acronym
NESTLE
Status last verified
Oct 2024
First submitted
31 Mar 2025
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Scientific dissemination - articles and conferences.

Publications

  • 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.

    PubMed 15828552

  • 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.

    PubMed 29016197

  • 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.

    PubMed 31031748

  • 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.

    PubMed 30413379

  • 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.

    PubMed 32936874

  • 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.

    PubMed 25575640

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Supplement in people with Nutritional Deficiency and Breast Cancer, run by D'Or Institute for Research and Education at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to the immunomodulatory nutritional supplementation regimen (time frame: Up to 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07021378, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in