Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors

Completed · Phase 2

Conditions studied: Rectal Carcinoma, Rectosigmoid Carcinoma

In brief

This phase II trial studies how a diet intervention works in improving bowel dysfunction symptoms related in colon or rectal cancer survivors. Changing a diet may be helpful in reducing the severity of bowel symptoms, including diarrhea and constipation, and improve quality of life in colon or rectal cancer survivors and help doctors learn how to help patients better in the future.

Key facts

Study ID

NCT04205955

Run by

SWOG Cancer Research Network

People needed

95

Starts

2020-02-10

Expected to finish

2023-08-01

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PRIOR TO STEP 1 REGISTRATION:
• Patients must have prior history of rectosigmoid colon cancer or rectal cancer
• Patients must have a post-surgical permanent ostomy or anastomosis
• Patient's last date of treatment for rectal cancer (any surgery, chemotherapy, radiation therapy) must be at least 6 months prior to registration and not more than 24 months prior to registration
• Anastomosis patients must have low anterior resection syndrome (LARS) score of 21-42 (minor to major symptoms) within 5 calendar days prior to registration
• Patient must have completed all baseline questionnaires within 5 days prior to registration
• Patients must be able to read, write and speak English. Study materials and telephone calls are only available in English
• Patients with a prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Patients who are currently undergoing treatment for another cancer will have a different symptom profile than what this study is targeting and are not eligible
• Patients who have been diagnosed with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease, are not eligible
• PRIOR TO STEP 2 REGISTRATION:
• Patient must meet all eligibility criteria for step 1
• Patient must have successfully completed ("pass") the run-in period, as per email notification from the University of Arizona
• Patient must be registered to step 2 no more than 40 days after step 1 registration. If day 40 falls on a weekend or holiday, the limit may be extended to the next working day
• Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Where it is running

• AnMed Health Cancer Center — Anderson, South Carolina, United States
• Prisma Health Cancer Institute - Spartanburg — Boiling Springs, South Carolina, United States
• Prisma Health Cancer Institute - Butternut — Greenville, South Carolina, United States
• Prisma Health Cancer Institute - Faris — Greenville, South Carolina, United States
• Prisma Health Cancer Institute - Eastside — Greenville, South Carolina, United States
• Prisma Health Cancer Institute - Greer — Greer, South Carolina, United States
• Prisma Health Cancer Institute - Seneca — Seneca, South Carolina, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Virginia Cancer Institute — Richmond, Virginia, United States
• VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States
• VCU Community Memorial Health Center — South Hill, Virginia, United States
• Shenandoah Oncology PC — Winchester, Virginia, United States
• Valley Health / Winchester Medical Center — Winchester, Virginia, United States
• Skagit Valley Hospital Regional Cancer Care Center — Mount Vernon, Washington, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center - Montlake — Seattle, Washington, United States
• Olympic Medical Cancer Care Center — Sequim, Washington, United States
• Wenatchee Valley Hospital and Clinics — Wenatchee, Washington, United States
• Langlade Hospital and Cancer Center — Antigo, Wisconsin, United States
• Marshfield Clinic-Chippewa Center — Chippewa Falls, Wisconsin, United States
• Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States

Full record on ClinicalTrials.gov

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