Chemoprevention of Head and Neck Squamous Cell Carcinoma (HNSCC) With Valproic Acid

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

July 31, 2017

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Valproic Acid

Half of the participants will receive valproic acid orally for three months. Saliva and blood will be sampled in the study entry. The participants will be followed with blood tests every month for three cycles. After the third cycle, saliva and blood will be sampled once more. Finally, histone acetylation and DNMT expression will be studied comparing the samples collected in different timelines and comparing them to saliva collected in placebo arm.

DRUG

Placebo

The other half of the participants will receive placebo for three months. Saliva and blood will be sampled in the study entry. The participants will be followed with blood tests every month for three cycles. After the third cycle, saliva and blood will be sampled once more. Finally, histone acetylation and DNMT expression will be studied comparing the samples collected in different timelines and comparing them to saliva collected in valproic acid arm.

Trial Locations (1)

14784-400

Barretos Cancer Hospital, Barretos

All Listed Sponsors
lead

Barretos Cancer Hospital

OTHER

NCT02608736 - Chemoprevention of Head and Neck Squamous Cell Carcinoma (HNSCC) With Valproic Acid | Biotech Hunter | Biotech Hunter