Hyperbaric Oxygen Therapy for Radiation Induced Xerostomia (Dry Mouth)

Hyperbaric oxygen therapy versus control to assess affect on quality of life and saliva analysis in patients with established xerostomia following radiotherapy in head and neck cancer.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000084886

Acronym

HOTRIX

Enrollment

Registered

2012-01-17

Start date

2012-04-24

Completion date

2013-03-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will assess the effect of hyperbaric oxygen therapy on quality of life and saliva in patients with dry mouth (xerostomia) following radiotherapy for head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18-90 years and have been diagnosed with xerostomia of at least 6 months duration following radiotherapy for head and neck cancer. Trial details Participants in this trial will be randomly (by chance ) allocated to one of two groups. Participants in one group will undergo 30 daily hyperbaric oxygen treatments of 90 minutes duration each. Participants in the other group will receive 30 placebo (control) treatments initially but will be offered the hyperbaric oxygen treatment after 3 months. Participants will not know which group they are in until the trial is completed. Participants will be regularly assessed over a 12 month period to determine their quality of life, saliva components and treatment costs.

Interventions

Hyperbaric oxygen therapy at 2.4 ATA for 30 treatments. Each treatment is 90 mins, daily (Mon-Fri) for 6 weeks.This would be at least 6 months after completion of radiotherapy.The treatment is given in a monoplace hyperbaric chamber so no hoods/ masks are required.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

head and neck cancer with radiation therapy>50Gy established xerostomia of at least 6 months duration no contraindiations to hyperbaric oxygen therapy

Exclusion criteria

Contraindication to hyperbaric therapy

Outcome results