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Cola

The control group (group 1) will continue their regular diet.

The intervention group (group 2) will get preoperative nutritional support two weeks before the operation and the nutritional support will continue 10 days after the operation.

regular diet

The intervention group (group 2) will get preoperative nutritional support (Resource 2.5 Compact/fibre combact) two weeks before the operation and the nutritional support will continue 10 days after the operation.

nutritional support Resource 2.5

Raila Aro

Sanna Meriläinen

Juha Saarnio, docent

This is a multicenter, unblinded, randomized study. The aim of this study is to research whether preoperative and postoperative oral nutritional supplement (ONS) (Resource 2.5 Compact/fibre compact) used at least 2 weeks prior the surgery and 10 days after surgery can improve the nutritional status of a colon cancer patient and reduce number of complications. The aim is also to investigate whether the oral nutritional support can shorten the hospital stay and improve the patients´ quality of life. The aim is also to find out whether the oral nutritional support can reduce 90-day mortality and improve disease free and overall survival.

Consecutive patients diagnosed with primary adenocarcinoma of the colon who are considered for radical surgical procedure are enrolled in this study provided that the inclusion criteria are filled.

Patients in the intervention group start oral nutritional support (ONS)2 portions a day for about 2 weeks prior to the operation starting at the time of randomization and continue ONS 10 days after the operation. Control group will continue with their regular diet without ONS until the operation. Both groups keep a food diary for 4 days right after the randomization and both one month and three months after the operation to assess the energy and nutrient intakes.

Laboratory markers, NRS 2002, quality of life questionnaire, exercise questionnaire, bioelectrical impedance analysis (BIA) and handgrip strength as well as body composition on computer tomography scan are assessed prior to any treatment or supplement in order to estimate the patients' well-being and nutritional status prior to surgical operation. Laboratory parameters and QoL questionnaire are repeated right before the operation on admission to hospital as well as about 30 and 90 days after the operation in addition to BIA, handgrip strength to assess the effect of nutritional support. Data on complications, infections, length of stay in the hospital and mortality are collected.

Another arm in this research is to discover more information on biological markers in colon cancer and cancer related malnutrition thus providing targets for future treatment and prognostic predictors. Tissue samples are collected during this research at the surgery.

The hypothesis in this study are:

1. Perioperative ONS decreases surgery related morbidity
2. Perioperative ONS increases the quality of life after surgery
3. Perioperative ONS decreases the length of stay in institutional care
4. Perioperative ONS decreases 90-day mortality and improve 5-year survival
5. Perioperative ONS benefits the patients to tolerate the adjuvant chemotherapy with less side effects
6. Perioperative ONS protects patients from postoperative nutritional depletion

Primary end point is to investigate whether the preoperative oral nutritional support decreases the number of complications during the 30-day follow up after the surgery. Secondary end points are to study the effect of oral nutritional support on quality of life after surgery, length of hospital stay, disease free and overall survival.

Randomization:

Patients having a surgery for adenocarcinoma of the colon are randomized on their preoperative visit in the outpatient clinic about 2-3 weeks prior to surgery.

The patients are randomized in two different groups according to NRS-2002 results. Both groups contain equal number of patients with normally nourished patients (NRS-2002 1-2) and malnourished patients by NRS 3 or more. NRS \>5 patients are excluded (nutritional support is recommended before the surgery). The control group (group 1) will continue their regular diet. The study group (group 2) will get preoperative nutritional support two weeks before the operation and the nutritional support will continue 10 days after the operation. The control group will continue their regular diet after the operation.

Thus the randomization groups will be (total number of patients 318):

1. no oral nutritional support (control group) n=159
2. pre and postoperative oral nutritional support (intervention group) n=159

Preoperative assessment and data-collection:

All patients attending this study have a visit in the out-patient clinic 2-3 weeks prior the surgery. The height and weight are measured at the baseline. 3 and 6 months previous weights recalled by patient. ASA (The American Society of Anesthesiologists) classification is estimated by anesthesiologist. Whole body computer tomography is done to assess the possibility of metastases or locally spread cancer. Laboratory markers including total blood count, CRP (C-reactive protein) , creatinine, sodium, potassium, albumin, prealbumin, HbA1c, CEA (Carcinoembryonic antigen), transferrin and lipids (LDL, HDL, triglycerides) concentration are measured. History of smoking, alcohol consumption and other diseases and medications are recorded. NRS-2002 questionnaire is filled, as well as QoL- questionnaire and exercise questionnaire. Bioelectrical impedance analysis (InBody) and handgrip strength are measured.

Laboratory parameters, as described above, are measured at the time of randomization, at admission to hospital on the morning of surgery, leaving the hospital and about 1 and 3 months and 1,2 and 5 years after surgery. BMI, hand grip strength, bioelectrical impedance analysis are collected and the patients fill the QoL-questionnaire and exercise questionnaire at the same time points. The side effects of chemotherapy are monitored, as well as discontinuation of chemotherapy. Complication form will be filled when necessary.

Follow- up:

Follow-up will be same as other colon cancer patients. The follow.up will continue 5 years and the only difference is 3 month phone call. Patients will also fill exercise and quality of life forms and bioimpedance and handgrip strength will be measured.

First follow up visit after the surgery is at the outpatient clinic 1 month after the surgery. At that time patient is interviewed about recovery from surgery, patients who went to health care center to recover from surgery are asked about the length of stay and possible complications after leaving the hospital. The patients´ fill the 4-day food diary, exercise questionnaire and QoL questionnaire (RAND-36). The blood samples are taken. Bioelectrical impedance analysis and handgrip strength are measured as well.

Second follow up at 3 months after the surgery is by phone. Then the recovery from surgery is checked, as well as patients are asked to keep 4-day food diary. The blood samples are collected. Patients fill quality of life and exercise questionnaire.

Patients have CEA, hemoglobin, leucocyte count and thrombocyte count measured every 3 months until 2 years, and every 6 months until 5 months on a routine basis. Whole body CT scan is done in a year after the surgery. There are also follow up CT scans at the oncology clinic on patients who receive adjuvant therapy. They will be utilized for analysis on recovery from the sarcopenia and its effect on survival and toxicity of chemotherapy. There are routine hospital visits 1,2 and 5 years after the surgery. Laboratory parameters, BMI, bioelectrical impedance analysis and handgrip strength are measures at each visit. The patients fill the QoL questionnaire and exercise questionnaire also at each time points. charlson comorbidity index and who classification are also marked.

A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri

A Prospective Multicenter Randomized Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer. Peri-Nutri

Primary end point is to investigate whether the pre and postoperative oral nutritional support decreases the number of complications during the 30-day follow up after the surgery

study the effect of oral nutritional support on quality of life after surgery (RAND-65 questionnaire)

study the effect of oral nutritional support on patients disease free and overall survival

effect of nutritional support on 90-day mortality

The aim is also to investigate whether the oral nutritional support can shorten the hospital stay

University of Oulu

Nutritional and Metabolic Diseases

Obesity

Polyps

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Rectal Diseases

Participants follow their normal diet (not including beans for 8 weeks)

Regular Diet

Participants add 1/2 cup of canned beans per day to their diets for the first 2 weeks. This is increased to 1 cup per day for the following 6 weeks of the study.

Navy Beans (Canned)

Carrie Daniel-MacDougall, PHD

You are being asked to take part in this study because either you are a survivor who has a previous history of colorectal cancer or an MD Anderson patient who had a precancerous colorectal polyp or you have a previous history of colorectal cancer, and you have a current adult body mass index (BMI) score of 25 or higher.

The BMI score is used as an indicator of the level of body fat, based on height and weight.

The goal of this clinical research study is to learn if eating canned, pre-cooked beans can help improve the levels of healthy bacteria in the digestive system and reduce the effects of obesity on cancer risk.

This is an investigational study.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Study Groups:

If you are found to be eligible, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (intervention or control). This is done because no one knows if one study group is better, the same, or worse than the other group. Both groups will be given a diet to follow for 8 weeks.

Intervention group participants will add canned beans into their diets beginning at ½ cup per day. This will be increased to 1 cup per day during the first 2 weeks, and then will continue at 1 cup per day for the following 6 weeks of the study. You will be asked to keep a log of your bean consumption during this time.

Control group participants will be instructed to follow their normal diet (not including beans) for 8 weeks.

Length of Study:

Your active participation on the study will last a total of 20 weeks. Your participation on the study will be over after the follow-up period.

Long-Term Follow-Up:

Up to 2 times each year for up to 5 years, a member of the study staff will contact you and ask about how you are doing. You will be contacted by phone, email, or standard mail. These calls will last 15-20 minutes each.

At 6 months and 1 year after your last visit, you will complete the same questionnaires you completed at screening.

Study Visits:

At each visit, your waist measurements and weight will be collected.

Every 4 weeks (Visits 2, 3, 4, 5, and 6), blood (about 3 tablespoons) will be drawn for routine tests. You will be asked to bring a stool sample to each visit and mail a stool sample at the end of week 1 during the intervention. You will be provided with a container and instructions to collect each stool sample. You may send your stool sample back to the study staff by mail. If you choose to send it by mail, you will be given a pre-paid envelope for this.

At Visit 4, your study group assignment will be switched, and you will be assigned to the opposite group and diet from your first assignment (meaning intervention group members will be switched to the control group as well as the other way around). You will follow this new diet for the remaining 8 weeks.

The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial

The primary outcome measures will be intra- and inter-individual changes in stool 16S rRNA gene profiles at baseline, week 4 and week 8 for each cross-over period.

The primary outcome measures will be intra- and inter-individual changes in blood makers and metabolites at baseline, week 8 for each cross-over period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri	NCT03863236	Colon Cancer Sarcopenia	regular diet nutritional sup...	18 Years -	University of Oulu
The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial	NCT02843425	Colorectal Canc...	Regular Diet Navy Beans (Can...	30 Years -	M.D. Anderson Cancer Center
A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri	NCT03863236	Colon Cancer Sarcopenia	regular diet nutritional sup...	18 Years -	University of Oulu
The Beans to Enrich the Gut Microbiome vs. Obesity's Negative Effects (BE GONE) Trial	NCT02843425	Colorectal Canc...	Regular Diet Navy Beans (Can...	30 Years -	M.D. Anderson Cancer Center

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