Neoplasms

All Conditions

Digestive System Diseases

Mouth and Tooth Diseases

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Mucositis

Neoplasms, Squamous Cell

Carcinoma

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Beetroot 10 grams concentrated organic beetroot crystals

Beetroot

Placebo

Travis Thomas, PH.D., RD

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.

This is a parallel 2-arm, 1:1 pilot randomized, placebo controlled supplementation study designed to examine improvements in chemoradiation compliance, body composition, strength/endurance, quality of life, nutrition status, and mucositis symptoms by supplementing beetroot juice over a period of 12 weeks. The Investigators plan to recruit 50 individuals with squamous cell carcinoma of the head and neck who are planning to undergo chemoradiation/intensity-modulated radiation therapy (IMRT). All subjects will be over 18 years of age. Eastern Cooperative Oncology Group (ECOG) performance status should be less than or equal to 2, which is necessary to ensure the patient can adequately participate in the supplementation and planned test procedures. All eligible participants will have a life expectancy greater than or equal to 3 months and normal organ and marrow function at the time of enrollment.

Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck

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

Peak force (kg) measured using a handgrip dynamometer

Handgrip strength (kg) at 30 seconds measured using a handgrip dynamometer

Bone mineral density (grams per centimeter squared)

Number of patients completing radiotherapy and three cycles of chemotherapy with no delay

Peak force (Nm) from one-legged maximum voluntary contraction (MVC) using the Biodex isokinetic machine.

David Travis Thomas

Associate Professor

Beetroot 10 grams concentrated organic beetroot crystals

Beetroot: 10g Beetroot powder mixed with 4-8 oz.

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The trial ended with only one participant in the placebo group. Intra-group and comparative statistics were thus not possible.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck	NCT02058849	Mucositis	Beetroot Placebo	18 Years -	University of Kentucky
Randomized Study of Beet Root in Locally Advanced Squamous Cell Cancer of the Head and Neck	NCT02058849	Mucositis	Beetroot Placebo	18 Years -	University of Kentucky

Spots Global Cancer Trial Database for beetroot

Every month we try and update this database with for beetroot cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for beetroot

Every month we try and update this database with for beetroot cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for beetroot cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.