Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery

NCT ID: NCT04029857

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2022-01-31

Brief Summary

This phase III trial studies nutritional supplementation with Impact Advanced Recovery to see how well it works compared with standard nutritional supplementation in reducing complications in patients with esophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing chemotherapy, radiation therapy, and/or surgery. Impact Advanced Recovery may help to reduce the number of surgical complications, reduce toxicity, improve nutritional status before surgery, and reduce morbidity after surgery in patients with esophageal cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. When compared to the current standard of ad hoc nutritional supplementation on an as-needed basis, scheduled enteral supplementation with Impact Advanced Recovery during the course of neoadjuvant therapy (for those in the planned trimodality group), preoperatively, and postoperatively will improve patient wellbeing by reducing weight loss (measured at baseline, preoperatively, and at postoperative follow-up) incurred during the course of therapy and will permit maintenance of patient performance status.

SECONDARY OBJECTIVES:

I. Decrease rates of a composite outcome that includes anastomotic leaks, ileus, major pulmonary events (pneumonia, reintubation, tracheostomy), wound infection, postoperative mortality, chyle leaks, and other postoperative complications.

II. Improve overall survival. III. Return to pre-surgical activity level (measured by Eastern Cooperative Oncology Group [ECOG] at baseline, preoperatively, and at postoperative follow-up).

IV. Decrease postoperative length of stay. V. Decrease incidence of esophagitis during and after radiation therapy. VI. Improve rates of completion of all planned neoadjuvant therapies (defined as receipt of a minimum of 41.4 Gray and two cycles of chemotherapy).

VII. Improve rates of lymphopenia.

EXPLORATORY OBJECTIVES:

I. Maintain or improve serum levels of arginine, citrulline, and albumin, while maintaining or decreasing serum levels of asymmetric dimethylarginine (ADMA) and C-reactive protein.

II. Improve immune function using peripheral markers such as CD4 count, CD4:CD8 ratio, CD3 zeta, myeloid-derived suppressor cells (MDSCs), IL-6 (interleukin 6), and IL-7.

III. Increase densities of tumor-associated immune cells (TAICs; including CD3+, CD8+, CD45RO+, CD57+, CD4+, FOXP3+, granzyme B+, CD68+, PD1+ cells) within the tumor tissue.

IV. Reduce platelet-to-lymphocyte, monocyte-to-lymphocyte, and neutrophil-to-lymphocyte ratios as measured by routine clinical complete blood counts.

V. Composition of intratumoral, peritumoral, and enteric microbiome.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive standard of care nutritional supplementation.

GROUP II: Patients receive Impact Advanced Recovery PO or via feeding tube twice daily (BID) on days 1-7 for weeks 1, 3, and 5 during chemotherapy and radiation therapy before surgery. Starting 5-7 days before surgery, patients receive Impact Advanced Recovery PO three times daily (TID) until surgery. Within 2 days following surgery, patients may continue to receive Impact Advanced Recovery via feeding tube at the discretion of the treating physician.

After completion of study, patients are followed up at 24 and 30 days.

Conditions

Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage III Esophageal Adenocarcinoma AJCC v8; Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8; Resectable Mass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group I (standard of care)

Patients receive standard of care nutritional supplementation.

Group Type: ACTIVE_COMPARATOR

Nutritional Supplement Drink

Intervention Type: DIETARY_SUPPLEMENT

Given standard of care nutritional supplementation

Group II (Impact Advanced Recovery)

Patients receive Impact Advanced Recovery PO or via feeding tube BID on days 1-7 for weeks 1, 3, and 5 during chemotherapy and radiation therapy before surgery. Starting 5-7 days before surgery, patients receive Impact Advanced Recovery PO TID until surgery. Within 2 days following surgery, patients may continue to receive Impact Advanced Recovery via feeding tube at the discretion of the treating physician.

Group Type: EXPERIMENTAL

Nutritional Supplementation

Intervention Type: DIETARY_SUPPLEMENT

Given Impact Advanced Recovery PO or via feeding tube

Interventions

Nutritional Supplement Drink

Given standard of care nutritional supplementation

Intervention Type: DIETARY_SUPPLEMENT

Nutritional Supplementation

Given Impact Advanced Recovery PO or via feeding tube

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Boost; Ensure; polymeric enteral nutrition formula; Supplementation

Eligibility Criteria

Inclusion Criteria

• Resectable, locally advanced esophageal cancer (adenocarcinoma, squamous cell, other histology).
• Medically operable.
• Treatment plan for (i) chemoradiation then surgery or chemotherapy followed by chemoradiation then surgery, or (ii) salvage esophagectomy.
• Able to tolerate feeds either orally or via tube gastrostomy or enterostomy.

Exclusion Criteria

• Allergy to supplement.
• Pregnant.
• Hepatic insufficiency.
• Serum creatinine > 2.0.
• Metastatic disease.
• Performance status of > or equal to 2.
• Inability to take either oral intake or enteral feeds or both.
• Given increased rates of perioperative morbidity and mortality historically observed at our institution, patients undergoing salvage resection for squamous cell carcinoma will not be eligible for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wayne L Hofstetter

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2019-04165

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0772

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0772

Identifier Type: -

Identifier Source: org_study_id