CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Beetroot +1 moredrug
Likely dose
Beetroot 10gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02058849
NCT02058849Phase 2Completed

Randomized Phase II Study of Concentrated Beet Root in Participants Being Treated for Locally Advanced Unresectable, Previously Untreated Squamous Cell Cancer of the Head and Neck

David Travis Thomas·interventional·Posted Feb 10, 2014·Updated Aug 14, 2019

In Brief

A Phase 2 clinical trial evaluating Beetroot and Placebo for Mucositis. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The objective of the current proposal is to determine if concentrated beet root could improve medical treatment compliance as defined by completion of radiotherapy and 3 cycles of chemoradiation without dose reduction, preserve fat-free mass, and strength while reducing mucositis. The investigators central hypothesis is that dietary nitrate supplementation in head and neck cancer patients receiving aggressive medical care will improve compliance with medical treatment by attenuating the loss of muscle mass and strength and reducing symptoms (mucositis) associated with treatment compared to patients receiving standard care with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucositis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2014
Enrollment StartDec 1, 2014
Primary CompletionApr 1, 2018
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.4 years ago

Interventions

Beetrootdrug

10g Beetroot powder mixed with 4-8 oz.

Placeboother

Placebo