A Study of Herbal Supplements in Cancer Survivors With Constipation

Inclusion Criteria

• •Age 18 years or greater;
• •A diagnosis of cancer with no restrictions placed on type of cancer or stage;
• •Completed surgery, chemotherapy, immunotherapy, and/or radiotherapy, or an investigational therapy at least one month prior to study initiation. Patients on stable doses of hormone therapy or targeted therapies will not be excluded;
• •Karnofsky functional score of ≥ 60;
• •Cancer survivors who have met the Rome IV criteria (Table 3) of the symptoms of functional constipation which must include two or more of the following:
• •* Straining more than 25% of defecations.
• •* Lumpy or hard stools (7-point Bristol stool scale 1 or 2) more than 25% of defecations.
• •* Sensation of incomplete evacuation more than one-fourth (25%) of defecations.
• •* Sensation of anorectal obstruction/blockage more than one-fourth (25%) of defecations.
• •* Manual maneuvers to facilitate more than one-fourth (25%) of defecations.
• •* Fewer than three spontaneous bowel movements per week.
• •* Loose stools are rarely present without the use of laxatives.
• •* Insufficient criteria for irritable bowel syndrome.
• •Patient should be able to understand and complete all study assessments on their own
• •Patient should be able to understand and provide signed informed consent in English.
• •Table 3. Rome IV criteria for functional constipation FUNCTIONAL CONSTIPATION Diagnostic criteria\*
• •1. Must include two or more of the following:\*\*
• •2. Straining during more than ¼ (25%) of defecations
• •3. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
• •4. Sensation of incomplete evacuation more than ¼ (25%) of defecations
• •5. Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations
• •6. Fewer than three SBM per week
• •7. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor)
• •9\. Loose stools are rarely present without the use of laxatives 9. Insufficient criteria for irritable bowel syndrome Note \*Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis