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| Name | Class |
|---|---|
| Nestle Health Science | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control cohort A: Routine nutrition orientation | Other | Control Cohort A: According to the institutional routine nutritional orientation |
|
| 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 |
|
| Control cohort B: Routine nutrition orientation | Other | Control cohort B: According to the institutional routine nutritional orientation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the immunomodulatory nutritional supplementation regimen | Percentage of adherence to the immunomodulatory nutritional supplementation regimen | Up to 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camila M. V. Moniz, MD-PhD | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto D'or de Pesquisa e Ensino | São Paulo | São Paulo | 04.501-000 | Brazil | ||
| Instituto do Câncer do Estado de São Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15828552 | Background | 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. | |
| 29016197 | 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. |
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Scientific dissemination - articles and conferences.
4 years
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Pilot study to evaluate the tolerance of imune nutritional supplement during cancer treatment.
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|
| 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. |
|
| Control Cohort A | Other | Control cohort A: According to the institutional routine nutritional orientation |
|
| Control cohort B | Other | Control cohort B: According to the institutional routine nutritional orientation |
|
| São Paulo |
| São Paulo |
| 05403-010 |
| Brazil |
| 31031748 | 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. |
| 30413379 | 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. |
| 32936874 | 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. |
| 25575640 | 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. |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D001943 | Breast Neoplasms |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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