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

NACompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 23, 2022

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2025

Conditions
Nutritional DeficiencyBreast CancerAnal Cancer
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."

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."

OTHER

Control Cohort A

Control cohort A: According to the institutional routine nutritional orientation

OTHER

Control cohort B

Control cohort B: According to the institutional routine nutritional orientation

Trial Locations (2)

04.501-000

Instituto D'or de Pesquisa e Ensino, São Paulo

05403-010

Instituto do Câncer do Estado de São Paulo, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Nestle Health Science

INDUSTRY

lead

D'Or Institute for Research and Education

OTHER