Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Peritoneal Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Patients undergoing primary surgical intervention complete surveys, undergo CT, and undergo collection of blood samples at baseline.

Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.

Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.

Behavioral Counseling

Nutritional Supplement Drink

Physical Activity

Survey Administration

Computed Tomography

Biospecimen Collection

Health Education

Medical Device Usage and Evaluation

Clinical Trials Referral Office

Amanika A. Kumar, M.D.

This clinical trial evaluates whether a prehabilitation program started at the time of neoadjuvant chemotherapy will affect surgical recovery in patients with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer. A prehabilitation program may improve the quality of life after surgery for patients with ovarian, fallopian tube, or primary peritoneal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the baseline difference in objective frailty measurements in patients with advanced ovarian cancer clinically deemed acceptable for primary surgery versus neoadjuvant chemotherapy.

II. To evaluate level of adherence and retention of patients with advanced ovarian cancer undergoing neoadjuvant chemotherapy with a prehabilitation program.

EXPLORATORY OBJECTIVE:

I. Will examine longitudinal trends and variability in function by the Short Physical Performance Battery (SPPB) over time and in response to the intervention.

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT 1: Patients undergoing primary surgical intervention complete surveys, undergo computed tomography (CT), and undergo collection of blood samples at baseline.

COHORT 2: Patients undergoing neoadjuvant chemotherapy complete physical activity for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily, and complete Resilient Living program in-person or remotely over 60 minutes. Patients also undergo CT scans throughout the trial.

COHORT 3: Patients undergoing neoadjuvant chemotherapy complete physical activity remotely for 30 minutes per day 3 times a week. Patients receive nutritional supplement drink up to 4.5 times daily. Patients also undergo health coaching remotely for 60 minutes weekly, complete Resilient Living program remotely over 60 minutes, and may wear a FitBit throughout the study.

Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

Prehabilitation for Advanced Ovarian Cancer Patients

Assessed based on patient reported adherence in Cohort 2. For cohort 3, adherence will be documented in MyDataHelps® and monitored remotely by the study team on the Care Evolution platform®. Participants will be evaluated weekly for compliance with the recommended exercise and nutrition and resilience interventions. Documentation of adherence will be through online patient messages, phone call, or during in person visits, whichever the patient prefers

Ability to recruit to this type of study and perform assessments at our institution will be measured based on the number of patients enrolled and the number of assessments completed throughout the study.

Short Physical Performance Battery (SPPB) will be measured at baseline in both cohorts.

The Short Physical Performance Battery (SPPB) assessment will be administered and scored at baseline and at each study visit to assess lower extremity functioning (balance, gait, standing up from a chair).

The following assessment tools will be completed at baseline, after chemotherapy/prior to surgery (cohort 2), 6 weeks post surgery (cohort 2), and after completion of all primary anti-cancer treatment (cohort 2): Short Physical Performance Battery (SPPB); gait speed (measured in meters/second); patient reported outcomes through Patient-Reported Outcomes Measurement Information System (PROMIS) short form surveys in the domains of pain, physical function, anxiety, emotional support, and fatigue; perceived stress scale; Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale.

The following assessments will be completed at baseline, after chemotherapy/prior to surgery (cohort 2), 6 weeks post surgery (cohort 2), and after completion of all primary anti-cancer treatment (cohort 2): Fried Frailty index; body composition measurements on CT scans performed for clinical purposes; serum collection for frailty biomarker; and Mindfulness Attention awareness scale. Results from these will be compared for correlation.

Qualitative data from weekly contacts and exit interviews will be analyzed for codes and organized in themes to elucidate barriers, facilitators, perceived benefits, and negative effects of the program.

Assessed using an Acceptability Questionnaire, which consists of 6 questions answered on a scale of 1-10 where 1=not at all and 10=extremely.

Mayo Clinic

Principal Investigator

Carcinoma, Squamous Cell

Adenocarcinoma

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Patients receive standard of care nutritional supplementation.

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.

Given standard of care nutritional supplementation

Given Impact Advanced Recovery PO or via feeding tube

Nutritional Supplementation

Wayne L Hofstetter

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.

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.

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

Nutritional Supplementation for Esophageal Cancer Patients Undergoing Trimodality Therapy

Will be measured by weight loss change incurred during the course of therapy and maintenance of patient performance status. The composite outcome will be Clavien-Dindo postoperative morbidity (POM) score, which is an ordinal health quality outcome variable with six levels: 0=normal recovery, 1=minor complication, 2=complication requiring pharmaceutical intervention, 3=complication requiring surgical, endoscopic or radiological intervention, 4=life-threatening complication requiring intensive care and 5=complication leading to the patient's death. Each patient will be monitored for up to 30 days after their operation, and their POM score based on this postoperative period will be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients	NCT05047926	Advanced Ovaria... Stage IIIC Fall... Stage IIIC Ovar... Stage IIIC Prim... Stage IV Fallop... Stage IV Ovaria... Stage IV Primar...	Behavioral Coun... Nutritional Sup... Physical Activi... Survey Administ... Computed Tomogr... Biospecimen Col... Health Educatio... Medical Device ...	18 Years -	Mayo Clinic
Prehabilitation for Stage IIIC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients	NCT05047926	Advanced Ovaria... Stage IIIC Fall... Stage IIIC Ovar... Stage IIIC Prim... Stage IV Fallop... Stage IV Ovaria... Stage IV Primar...	Behavioral Coun... Nutritional Sup... Physical Activi... Survey Administ... Computed Tomogr... Biospecimen Col... Health Educatio... Medical Device ...	18 Years -	Mayo Clinic
Nutritional Supplementation in Reducing Complications in Patients With Locally Advanced Esophageal Cancer Undergoing Chemotherapy, Radiation Therapy, and/or Surgery	NCT04029857	Clinical Stage ... Clinical Stage ... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Pathologic Stag... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Postneoadjuvant... Resectable Mass	Nutritional Sup... Nutritional Sup...	18 Years - 80 Years	M.D. Anderson Cancer Center

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