Impact of Adjuvant Chemotherapy in Patients With Colon Cancer

NCT03213444 | Completed

• 1 other identifier: Adjuvant Chemotherapy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages II and III colon cancer. Will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

Conditions

Colon Cancer; Adjuvant Chemotherapy

Keywords

Colon cancer; adjuvant chemotherapy; sympathetic nerve activity; peripheral vascular function

Outcome Measures

Primary Outcomes (1)

• cardiac function evaluation

  Cardiac function will be assessed by two-dimensional (B-mode) echocardiography, pulsed Doppler

  Change from Baseline cardiac function at 6 months

Secondary Outcomes (4)

• vascular function evaluation

  Change from Baseline vascular function at 6 months

• autonomic control evaluation

  Change from autonomic control at 6 months

• functional capacity evaluation

  Change from Baseline functional capacity at 6 months

• Proinflammatory cytokines

  Change from Baseline Proinflammatory cytokines at 6 months

Study Arms (2)

Quimioterapy 1

ACTIVE COMPARATOR

adjuvant chemotherapy with 5-FU isolated

Drug: adjuvant chemotherapy with 5-FU isolated

Quimioterapy 2

ACTIVE COMPARATOR

adjuvant chemotherapy with 5-FU associated with oxaliplatin

Drug: adjuvant chemotherapy with 5-FU associated with oxaliplatin

Interventions

adjuvant chemotherapy with 5-FU isolated DRUG

Patients submitted to adjuvant chemotherapy with 5-FU isolated

Quimioterapy 1

adjuvant chemotherapy with 5-FU associated with oxaliplatin DRUG

Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin

Quimioterapy 2

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scale of Performance Status 0 - 1
• Patients submitted to colectomy for adenocarcinoma of colon stages II and III.

You may not qualify if:

• Severe pulmonary disease
• Decompensated cardiovascular disease
• Neurological disease
• Insulin-dependent diabetes mellitus
• Dialysis renal insufficiency

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Sociedade Beneficente de Senhoras Hospital Sírio-Libanês

São Paulo, 01.409-000, Brazil

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Chemotherapy, Adjuvant; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with stage II disease undergoing adjuvant 5-FU treatment will be allocat in chemotherapy-1 group, while stage III patients undergoing combined adjuvant chemotherapy (5FU + Oxaliplatin) will be allocat to the Chemotherapy group -2.

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 11, 2017
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: February 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)