Skip to content

Early tube feeding in head and neck cancer

A randomized comparison of early prophylactic feeding via gastrostomy versus standard care in high risk patients with head and neck cancer to determine impact on nutrition outcomes, quality of life and clinical outcomes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000579897
Enrollment
123
Registered
2012-05-29
Start date
2012-09-19
Completion date
Unknown
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 aims to compare the outcome of early tube feeding compared to commencement of feeding as per current standard practice in patients undergoing gastrostomy prior to treatment for head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with head and neck cancer, and have been referred for a preventive gastrostomy (insertion of feeding tube into the stomach) prior to treatment for your cancer. Trial details Participants in this trial will be randomly (by chance) allocated to one of two treatment groups. Participants in one group will commence two supplementary feeds per day at the time of feeding tube insertion (gastrostomy). These feeds will be in addition to the patient's usual dietary intake and will continue throughout cancer treatment. Participants in the other group will receive standard care. This involves water flushes via the gastrostomy throughout cancer treatment and feeds will be commenced by the dietitian as clinically indicated during treatment. Participants will be assessed at baseline and 3 months post completion of treatment in order to determine impact on nutrition outcomes, quality of life and clinical outcomes.

Interventions

Patients randomised to the intervention will commence two supplementary bolus feeds (standard enteral formula 1.5kcal/ml with fibre) per day in addition to usual dietary intake at the time of gastrostomy placement. The supplementary feeds will continue pre treatment and throughout treatment. Most patients will be anticipated to be receiving chemoradiotherapy with a duration of 7 weeks. Tube placement is usually within 1-2 weeks prior to chemoradiotherapy, and so total predicted duration of inte

Patients randomised to the intervention will commence two supplementary bolus feeds (standard enteral formula 1.5kcal/ml with fibre) per day in addition to usual dietary intake at the time of gastrostomy placement. The supplementary feeds will continue pre treatment and throughout treatment. Most patients will be anticipated to be receiving chemoradiotherapy with a duration of 7 weeks. Tube placement is usually within 1-2 weeks prior to chemoradiotherapy, and so total predicted duration of intervention is 8-9 weeks. Additional feeds will be commenced as clinically indicated during treatment by the clinical dietitian.

Sponsors

Teresa Brown
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosed with head and neck cancer AND Referred for prophylactic gastrostomy prior to treatment

Exclusion criteria

patients with severe malnutrition at diagnosis OR patients with moderate malnutrition and severe dysphagia at diagnosis (requiring puree/liquid diets)

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 9, 2026