Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04029857 |
| Other study ID # |
2017-0772 |
| Secondary ID |
NCI-2019-0416520 |
| Status |
Withdrawn |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
March 14, 2019 |
| Est. completion date |
January 31, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
