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NCT04700527
LCCC2032: The Effects of Short Chain Fatty Acid Supplementation on the Quality of Life and Treatment-related Toxicities in Subjects Receiving Abdominopelvic Radiotherapy: A Randomized Controlled Study
Phase 1/Phase 2 trial testing Short Chain Fatty Acid in Toxicity in 122 participants. Currently enrolling.
21 April 2027
Quick facts
| Lead sponsor | UNC Lineberger Comprehensive Cancer Center |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 122 |
| Start date | 15 December 2023 |
| Primary completion | 21 April 2027 |
| Estimated completion | 1 May 2031 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Short Chain Fatty Acid — full drug profile →
- Tapioca Flour — full drug profile →
Conditions studied
- Toxicity — all drugs for Toxicity →
- Radiation Toxicity — all drugs for Radiation Toxicity →
Sponsor
UNC Lineberger Comprehensive Cancer Center — full company profile →
Who can join
18 and older, any sex, with Toxicity or Radiation Toxicity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The rate and severity of patient reported and physician determined toxicities between subjects who receive therapeutic SCFA and those who receive placebo.
Time frame: baseline-3 months
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.
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Butyrate as a promising therapeutic target in cancer: From pathogenesis to clinic (Review).
Sun J, Chen S, Zang D, Sun H, et al · · 2024 · cited 71× · PMID 38426581 · DOI 10.3892/ijo.2024.5632 -
Disentangling the molecular mystery of tumour-microbiota interactions: Microbial metabolites.
Duan YF, Dai JH, Lu YQ, Qiao H, et al · · 2024 · cited 13× · PMID 39568157 · DOI 10.1002/ctm2.70093 -
Short-chain fatty acids in the tumor microenvironment: from molecular mechanisms to cancer therapy.
Xiang Y, Du A, Wang Z, Pan H, et al · · 2026 · cited 1× · PMID 41355959 · DOI 10.7150/thno.119304 -
Unveiling the Interplay Between the Human Microbiome and Gastric Cancer: A Review of the Complex Relationships and Therapeutic Avenues.
Al-Matouq J, Al-Ghafli H, Alibrahim NN, Alsaffar N, et al · · 2025 · cited 1× · PMID 39858007 · DOI 10.3390/cancers17020226
Verify or expand the search:
- PubMed search for NCT04700527
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Short Chain Fatty Acid
Trials testing the same drug.
- NCT06951581 — Impact of SCFA Supplementation on Metabolic Profiles in Serum and Urine of Kidney Transplant Recipients. · NA · completed
Other recruiting trials for Toxicity
Currently open trials in the same condition.
- NCT06870617 — Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70) · recruiting
- NCT06542159 — Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer · Phase 2 · recruiting
- NCT06044623 — Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast · Phase 3 · recruiting
- NCT06281886 — Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advance · Phase 2 · active not recruiting
- NCT04879563 — Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project · Phase 2 · active not recruiting
Other UNC Lineberger Comprehensive Cancer Center trials
Trials by the same sponsor.
- NCT06656936 — The PharmFIT Study · NA · not yet recruiting
- NCT05937659 — Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT · not yet recruiting
- NCT07479199 — Local Radiofrequency Ablation Plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors · not yet recruiting
- NCT07069595 — PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease · Phase 2 · recruiting
- NCT04266730 — Trial of a Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine Concurrently With Pembrolizumab · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04700527 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center
- Last refreshed: 1 June 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04700527.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing