Anal Cancer, Breast Cancer, Nutritional Deficiency
Conditions
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.
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.
Interventions
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.
OTHERControl Cohort A
Control cohort A: According to the institutional routine nutritional orientation
OTHERControl cohort B
Control cohort B: According to the institutional routine nutritional orientation
Sponsors
Nestle Health Science
D'Or Institute for Research and Education
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pilot study to evaluate the tolerance of imune nutritional supplement during cancer treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the immunomodulatory nutritional supplementation regimen | Up to 36 weeks | Percentage of adherence to the immunomodulatory nutritional supplementation regimen |
Countries
Brazil
Outcome results
None listed