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The purpose of this study is to assess and compare GI toxicity from RT between subjects who receive therapeutic SCFA and those who receive placebo, in hopes of identifying a safe, low-cost therapeutic to reduce GI toxicity from therapeutic or environmental radiation.
Radiation therapy is a critical modality for treatment of urologic, gynecologic and gastrointestinal malignancies among others. Though advances in treatment techniques have reduced treatment-associated morbidity and mortality, normal tissue toxicity still limits dose escalation and treatment tolerance. Over 50% of patients receiving abdominal or pelvic radiation therapy (RT) develop clinically meaningful toxicity. Pharmacologic strategies to reduce normal tissue damage represent a tremendous unmet need in RT. Investigators propose a novel application of short chain fatty acids (SCFA) as a therapeutic to reduce incidence and severity of gastrointestinal (GI) toxicity from RT. Short chain fatty acids (SCFA) are fatty acids with fewer than six carbon atoms ingested or formed during bacterial fermentation of partially- and non-digestible polysaccharides carbohydrates. Patients who are enrolled will be randomized to receive SCFA supplements or a placebo, and will start taking it everyday one week prior to starting RT through 1 week after completing RT. Patients will keep a log of daily administration during the entire time while taking the study drug, and will complete patient reported outcomes (PROs) involving toxicities starting at baseline through 3 months post RT. The patient's treating physician will also complete an assessment of the patients toxicities starting at the baseline through follow up visits up to 5 years post RT, which will be used to compare to the PROs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Chain Fatty Acid (SCFA) | Active Comparator | 4-6 grams of powder mixed with food and taken everyday starting 1 week prior-1 week post Radiation Therapy. |
|
| Placebo (Tapioca) | Placebo Comparator | 5 grams taken everyday starting 1 week prior-1 week post Radiation Therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Chain Fatty Acid | Drug | Participants will take the supplement as prescribed to determine if it can help with GI toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo. | GI toxicities (PRO-CTCAE v5 for patients and CTCAE v5 for physicians) will be recorded and compared between the 2 groups to identify any differences. | baseline-3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physician determined acute toxicity profile using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) for both subjects who receive therapeutic SCFA versus those who receive placebo. | Physicians will complete toxicity assessments using the CTCAE v5 at each visit with the patient up until 5 years post RT | baseline- up to 5 years post RT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flora Danquah | Contact | 9849748441 | flora_danquah@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shivani Sud, MD | UNC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flora Danquah | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005232 | Fatty Acids, Volatile |
| D020148 | Butyric Acid |
| C514135 | sodium propionate |
| ID | Term |
|---|---|
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 |
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| Tapioca Flour | Drug | Participants taking this will be used as a control group compared to those receiving the SCFA supplement |
|
| Subject reported acute toxicity profile as ascertained by patient-reported outcomes version of the CTCAE (PRO-CTCAE) for both subjects who receive therapeutic SCFA versus those who receive placebo. | Patients will complete PRO-CTCAE at each visit starting at baseline through 3 months after completing the study drug. | baseline- 3 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| Carboxylic Acids |
| D009930 | Organic Chemicals |