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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-23

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nutritional Deficiency Breast Cancer Anal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Dietary Supplement

Intervention Type 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.

Control cohort A: Routine nutrition orientation

Control Cohort A: According to the institutional routine nutritional orientation

Group Type OTHER

Control Cohort A

Intervention Type OTHER

Control cohort A: According to the institutional routine nutritional orientation

Cohort B: Patients with anal canal cancer with dietary supplementary

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

Group Type EXPERIMENTAL

Dietary Supplement

Intervention Type 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 B: Routine nutrition orientation

Control cohort B: According to the institutional routine nutritional orientation

Group Type OTHER

Control cohort B

Intervention Type OTHER

Control cohort B: According to the institutional routine nutritional orientation

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Control Cohort A

Control cohort A: According to the institutional routine nutritional orientation

Intervention Type OTHER

Control cohort B

Control cohort B: According to the institutional routine nutritional orientation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No