A trial looking at two surgical treatments for early mouth cancer (SEND-001)

Removing the lymph glands at the same time as the mouth cancer when there is no evidence that the cancer has spread to the glands increased the cure rate. 

About this trial
596 people in 28 UK hospitals joined the trial. 

For 230 people who had no signs of cancer in their neck glands neither they nor their doctor chose which type of surgery they had. They were put into 1 of the 2 groups at random. These were the randomised patients.
 

• 114 had their cancer and lymph glands removed.
• 116 had only their cancer removed.

Diagram 1

Also, as part of the study, 346 people chose which type of surgery they had with their surgeon. These patients were not randomised. 

• 112 people had their cancer and lymph glands removed.
• 234 people had only their cancer removed.

Results
The researchers found that the results of the randomised patients were similar to those from the patients who had not been randomised. This strengthens the evidence and recommendations from this project.

In this summary we are providing the results for only the randomised patients. 

The average follow up was just under 5 years (57 months).

The team looked at how many people were alive at 5 years after treatment. They found it was:

• 77 people out of every 100 (77.5%) who had their cancer and lymph glands removed
• 65 people out of every 100 (65.6%) who had only their cancer removed 

This shows that people who have their cancer and lymph glands removed at the same time are more likely to be alive at 5 years after treatment than people who have only their cancer removed.

Graph 1

At 5 years after treatment they looked at the number of people who had no sign of their cancer coming back. They found it was:

• 64 people out of every 100 people (64.4%) who had their cancer and lymph glands removed
• 50 people out of every 100 (50.9%) who had only their cancer removed

This shows that people who have their cancer and lymph glands removed at the same time are more likely to stay alive and free of cancer than people who have only their cancer removed.

Graph 2

Quality of life
The quality of life reported by both groups was similar overall. 

Where it was statistically significant  the differences were:

• people who had their cancer and lymph glands removed were more likely to experience a dry mouth compared to people who had only their cancer removed 
• people who had their cancer and lymph glands removed were less likely to feel nauseous compared to people who had only their cancer removed

Complications from surgery
People who had their cancer and lymph glands removed reported more complications. But the majority were not severe. 

There was no major difference in the number of severe side effects reported by both groups. 

The most common side effects reported by both groups were:

• problems with the nerves in the neck causing a decrease in feeling and movement
• swallowing problems 

However these side effects were short lived and disappeared in most people.

Time in hospital 
The researchers compared the average number of days in hospital after surgery. They found it was:

• 6 days for those who had their cancer and lymph glands removed
• 2 days for those who had only their cancer removed

Up to 2 years after the surgery the average number of days people were in hospital were:

• 4½ days for those who had their cancer and lymph glands removed
• 3 days for those who had only their cancer removed

The team also found there wasn’t much difference between the groups in the number of:

• clinic (outpatient) appointments 
• GP visits 

Conclusion
The team conclude these results provide clear evidence about the benefits and impact of surgery to remove the cancer and lymph glands in the same operation, even with the smallest mouth cancers. 

They say this should remove the uncertainty in national guidelines about removing the cancer and lymph glands at the same time. They also provide measurable evidence between the 2 groups comparing:

• quality of life
• hospital stays
• outpatient and GP visits
• complications after surgery

All this information can help patients take a more active part in the decisions regarding their treatment. 

The surgeons collected blood samples and samples of cancer tissue. They plan to do laboratory research to see if they can find factors in the samples such as genes that might tell them who would need SEND and who wouldn’t. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.