WithdrawnPhase 3

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

Stopped: 0 participant accrual

0Started 2019-03-14

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Patient well-being improvement

Timeframe: Up to 30 days post-surgery

Trial details

NCT IDNCT04029857

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31