Digestive System Diseases

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Patients will chew sugar free gum three times a day

Chewing gum

Dale Vimalachandran, MD FRCS

Sheila Williams

Rachel Clifford, MRCS

It is unknown whether post operative chewing gum will reduce post operative ileus. This study is a randomised controlled trial that will determine whether chewing gum three times a day following surgery will reduce post operative ileus. Time to passage of flatus will be used to determine that incidence of ileus.

Patients will be randomised to one of two arms, the experimental arm will be chewing gum and the control arm will be normal post operative care.

The primary endpoint is time to passage of flatus (defined as end of operation to first passage of flatus, in minutes).

The trial will be unblinded to patients and observers and has been powered to demonstrate a 15% reduction in passage to flatus (130 patients required)

Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery

Randomised Controlled Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery

Countess of Chester NHS Foundation Trust

Consultant Colorectal Surgeon

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Head and Neck Neoplasms

Xerostomia

Oropharyngeal Neoplasms

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Patients use tasteless and sugar free chewing gum up to 5 times a day for 1 month.

Daily registrations in a patient dairy.

Patients continue with daily routine to relieve oral discomfort. No chewing gum allowed.

Julie K Kaae, MD

This study evaluates the possible benefits of a tasteless and sugar free chewing gum as a salivary stimulant for head and neck cancer patients treated with curative intended radiotherapy.

Radiation-induced xerostomia and hyposalivation are frequent side effects after completed treatment for oral and oropharyngeal cancers. This may induce eating and swallowing difficulties, compromised oral hygiene, pain in the mouth, or speech deficiencies. As a consequence, quality of life is often impaired for this group of patients even after completing treatment.

This study hypothesize that chewing gum can stimulate salivary flow from the residual functional salivary glands and thereby improving the patient's oral well-being.

Primary endpoint:

- To assess whether the difference between the unstimulated and stimulated salivary flow after a one-month period of using chewing gum will result in improved oral well-being.

Secondary endpoint:

* To assess if unstimulated and stimulated salivary flow differs between the two groups of patients
* To evaluate changes in quality of life with EORTC QLQ H\&N-35 for patients using chewing gum
* To evaluate differences in quality of life with EORTC QLQ H\&N-35 between the two groups of patients.

All patients who have received curative intended treatment for oral or oropharyngeal carcinomas at the Department of Oncology, Odense University Hospital, will be invited to participate in the study. If the eligibility criteria are met the patient will be randomized 2:1 to either the intervention arm with chewing gum or the control arm with standard oral care. The study intends to include 210 patients in total. Of these, 140 patients in the intervention arm and 70 in the control arm. Recruitment to the study was initiated in September 2016 and is expected to be completed in July 2018.

The duration of the study is one month from inclusion and randomization to final follow up. For all included patients, saliva samples are collected (unstimulated and stimulated sialometry) and the EORTC QLQ H\&N-35 questionnaire and a xerostomia specific questionnaire are completed. The patients in the control arm are only introduced to chewing gum at the last follow up visit. In the intervention arm, all patients are instructed to use the chewing gum on a daily basis (preferably 5 times a day) and to make notes in a patient diary to document compliance.

2:1 randomization in favor of chewing gum (intervention)

The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors

Patients in the intervention arm will experience increase in stimulated salivary flow at follow up as compared to unstimulated salivary flow at baseline.

The difference between unstimulated and stimulated salivary flow will be higher for patients in the intervention arm as compared to the difference in salivary flow for patients in the control arm.

Danish Cancer Society

Odense Patient Data Explorative Network

Odense University Hospital

M.D.

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Pancreatic Cancer

This intervention group will receive chewing gum four times daily following surgery. Each of which they are encouraged to chew for 30 minutes.

Gum chewing is terminated when one of the primary end points occurs.

This group will receive the normal postoperative treatment. Occurence of primary end points are registrered.

The intervention group will receive chewing gum four times daily following surgery.

Christian Lolle Norregaard, MD

Michael Bau Mortensen, Professor

Every patient undergoing surgery in the abdomen will experience temporary paralysis of bowel function. This study evaluates whether chewing gum can reduce the bowel paralysis after surgery in patients undergoing either esophageal resection or whipples procedure. Half the study population will receive chewing gum while the other half will act as control.

Every surgical procedure results in a temporary paralysis of bowel function. This condition is named postoperative ileus (POI) and it is characterized by absence of intestine motility, accumulation of gas and fluid inside the intestines and absence of flatus and defecation. It results in nausea, vomiting, abdominal distension, pain and lowered tolerance towards intake of fluid and solid foods. POI is the organism's reaction to the surgical trauma and it is most often the single most important factor determining the length of patient admission. Prolonged POI can also result in medical complications.

The length of POI following elective abdominal surgery is most often 3 to 6 days. Gradually during this period the intestines regain their normal behavioral pattern. The colon is the last segment to regain its motility which decides the patient's wellbeing. Therefore most investigations of POI measure time from surgery to first flatus or defecation.

The cause of POI is found in the surgical trauma. When the abdominal wall and the peritoneum are penetrated and the intestines exposed and handled, the immune system is activated. The immune system creates an inflammatory response that inhibits the local neural pathways in the intestines. The size of the immune response is related to the size of the surgical procedure and the length of POI. Together with the overall hormonal surgical stress response the inflammatory response creates a shift in the autonomous nervous system towards sympathetic domination. This further inhibits bowel activity.

The intake of food activates parasympathetic activity and promotes bowel activity. Early food intake following abdominal surgery, however, is often ill received by the patients hence the above mentioned symptoms of POI. The early food intake can also worsen complications following surgery such as anastomotic leakage. This is most pronounced with anastomoses on the esophagus and stomach. Therefore abstinence from food intake is often recommended in the immediate postoperative period.

Chewing of chewing gum following surgery can be perceived as placebo intake of food because it also activates the parasympathetic nervous system and under normal conditions the cephalic part of the digestion. Gum chewing does not, however, result in worsening of potential surgical complications and it is generally well tolerated by the patients. Postoperative gum chewing has been investigated and found effect full in the shape of reduced POI following colorectal surgery, abdominal surgery on the aorta, bladder surgery, and caesarian section.

The effect of gum chewing following surgery on the esophagus and the pancreas has to our knowledge not yet been investigated.

With this study we wish to investigate the effect of gum chewing on POI in a patient population undergoing either esophageal resection or pancreaticoduodenectomy (whipples procedure) due to cancer in either the esophagus or the pancreas.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Chewing Gum to Reduce Post Operative Ileus in Elective Colorectal Surgery	NCT02372500	Colorectal Canc... Surgery	Chewing gum	18 Years -	Countess of Chester NHS Foundation Trust
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors	NCT03302676	Head and Neck C... Radiation Thera... Xerostomia Hyposalivation	Chewing gum	18 Years -	Odense University Hospital
Effect of Chewing Gum on Postoperative Bowel Function Following Upper GI Tract Cancer Surgery	NCT02260128	Cancer Esophagu... Pancreatic Canc...	Chewing gum	18 Years -	Odense University Hospital

Spots Global Cancer Trial Database for chewing gum

Every month we try and update this database with for chewing gum 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 chewing gum

Every month we try and update this database with for chewing gum 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 chewing gum 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.