Meal Impact on Radiation Planning for Liver Cancer

Overseen By Brieanna Marino, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Prior liver radiation, Renal insufficiency, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how eating affects radiation treatment planning for liver cancer. Researchers seek to understand how liver size changes throughout the day and after meals might impact radiation therapy. Participants will undergo CT scans before and after consuming a standardized high-carbohydrate meal to observe these changes. The trial suits individuals with upper abdominal cancer who have not received prior radiation to the liver and can fast for at least 8 hours. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance future radiation treatment strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a condition that prevents you from fasting, you may not be eligible to participate.

What prior data suggests that this protocol is safe for liver cancer patients?

Research has shown that the high-carbohydrate meals used in this trial are generally safe for most people. These meals often include products like Ensure® nutritional shakes, which are easy to digest and provide balanced nutrition. The trial has not identified any specific safety concerns related to these meals.

While other studies have linked high-fat diets to liver issues, this trial uses a high-carb diet, so those concerns do not apply. The goal is to observe how eating affects liver size, not to test new drugs or risky treatments. Therefore, based on existing dietary research, participation in this trial appears safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how a high-carbohydrate meal might affect the precision of radiation therapy planning for liver cancer. Unlike traditional methods that rely solely on fasting scans, this approach investigates whether eating a standardized meal like Ensure® can alter liver positioning or size, potentially leading to more accurate targeting of cancerous tissues. If successful, this method could enhance treatment efficacy and reduce radiation exposure to healthy tissues, making liver cancer treatment safer and more effective.

What evidence suggests that this method is effective for liver cancer treatment planning?

Early research shows that changes in liver size can affect the accuracy of radiation delivery during cancer treatment. This trial will examine how a high-carbohydrate meal might alter liver size before and after consumption. Strong evidence suggests that diet can impact liver health and may influence the risk of liver cancer. However, specific information on how a standard high-carb meal affects radiation planning for liver cancer remains unknown. By understanding how meals change liver size, the study aims to improve the precision of liver cancer treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

Susannah Ellsworth, MD

Principal Investigator

UPMC Hillman Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with primary upper abdominal cancers (like pancreatic, bile duct, or liver) or metastases in the area who are set to receive SBRT. They must be able to fast and not have had previous radiation therapy to the liver. Pregnant women or those who can't use contraception during treatment cannot join.

Inclusion Criteria

I have cancer in my upper abdomen or its metastases and am planned for SBRT.

Exclusion Criteria

Inability to fast.

Contraindication to receipt of iodinated IV contrast for CT (such as renal insufficiency or allergy that cannot be overcome by premedication)

I am not pregnant or breastfeeding and willing to use contraception during treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial CT scan after an overnight fast for treatment planning

1 day

1 visit (in-person)

Intervention and Scanning

Participants consume a high-carb meal followed by two additional CT scans to assess liver volume changes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standardized high-carbohydrate meal

Trial Overview The study is looking at how eating a standardized high-carbohydrate meal before treatment affects liver volume and thus impacts planning and delivery of SBRT for stomach cancer and other upper abdominal malignancies.

How Is the Trial Designed?

Group I: High Carbohydrate Diet Experimental Treatment 1 Intervention

1. First scan: after an overnight fast of at least 8 hours using standard radiation oncology CT scan with contrast for treatment planning. 2. Standardized high-carb meal such as 8 ounces of Ensure® nutritional protein shake or a similar meal, immediately following first scan and consumed within 15 minutes. 3. Second scan: within 1 hour of ingestion of the high-carb meal using similar settings to those used in the first scan except for contrast use. 4. Third CT scan at least 4 hours (but no more than 5 hours) after ingestion of high-carb diet on the same day utilizing same set up used in first scan with exception for the use of contrast.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

American College of Radiation Oncology

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study of 45 elderly men undergoing radiotherapy for prostate cancer, the antifermentative diet led to a significant decrease in energy and nutrient intake, including essential vitamins and minerals, during treatment.

Body composition was adversely affected by the diet, with participants experiencing reductions in body weight, arm circumference, and other measurements by the end of radiotherapy, indicating potential negative impacts on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the antifermentative diet during radiotherapy for prostate cancer in elderly, SÃO Paulo, Brazil. de Oliveira Pedron, ÉL., de Cássia de Aquino, R., Borin da Silva, C.[2021]

A dietary intervention aimed at reducing insoluble fiber and lactose intake in patients undergoing high-dose radiotherapy for prostate cancer did not significantly improve long-term gastrointestinal symptoms or health-related quality of life compared to a standard diet.

Most gastrointestinal symptoms reported by patients post-treatment were mild, with the only notable changes being related to unintentional stool leakage and limitations on daily activities, indicating that dietary changes may not be necessary for symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a dietary intervention on gastrointestinal symptoms after prostate cancer radiotherapy: long-term results from a randomized controlled trial. Pettersson, A., Nygren, P., Persson, C., et al.[2018]

A survey of 14 Dutch Head and Neck Oncology centres revealed significant variations in nutritional interventions during chemoradiotherapy, particularly in the use of gastrostomy for tube feeding, with 77% of centres using it for most patients.

There is a need for standardized dietetic guidelines, as practices varied widely, including the number of dietetic consultations (2 to 7), methods for calculating energy and protein requirements, and the timing for removing gastrostomies after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional interventions in patients with head and neck cancer undergoing chemoradiotherapy: Current practice at the Dutch Head and Neck Oncology centres. Kok, A., van der Lugt, C., Leermakers-Vermeer, MJ., et al.[2022]

The Malnutrition Universal Screening Tool (MUST) was validated in a study of 450 cancer patients undergoing radiotherapy, showing high sensitivity (0.80) and specificity (0.89) for identifying those at nutritional risk, making it a reliable screening method.

Percentage weight loss over the previous 3-6 months was found to be a highly effective indicator of undernutrition, with a sensitivity of 0.76 and specificity of 0.85, suggesting it could be a quick and practical measure for routine nutritional assessments in busy clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Malnutrition Universal Screening Tool (MUST) in cancer. Boléo-Tomé, C., Monteiro-Grillo, I., Camilo, M., et al.[2019]

Radiotherapy targeting the gastrointestinal tract can lead to significant nutritional issues due to its impact on normal tissue function, with effects varying based on radiation dose, timing, and treatment area.

To mitigate these nutritional consequences, careful monitoring and supportive therapy are essential, and further clinical trials are needed to explore how nutritional support can enhance tolerance to radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional consequences of radiotherapy. Donaldson, SS.[2006]

Rats on an elemental diet required 37% more radiation to reach both 0% and 100% mortality compared to those on laboratory chow, indicating enhanced radio-resistance in the elemental diet group.

Both groups experienced similar levels of anorexia, but the rats on the elemental diet lost weight more slowly, suggesting that this diet may provide some protective effects against radiation-induced weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary enhancement of intestinal radioresistance during fractionated irradiation. Pageau, R., Saint-Pierre, C.[2007]

In a study of 352 patients with laryngeal and oropharyngeal cancers treated with radiation therapy, those who complied with nutritional counseling showed a significant 31% reduction in disease progression risk.

Higher pretreatment body mass index (BMI) was associated with a lower risk of death and disease progression, suggesting that maintaining a healthy weight may be beneficial for patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of dietary regimen compliance on outcomes for HNSCC patients treated with radiation therapy. Kabarriti, R., Bontempo, A., Romano, M., et al.[2022]

Patients undergoing radiation therapy for cancer are at risk for nutritional issues due to both their cancer and the treatment itself, which can be acute or chronic depending on the tumor location and irradiated areas.

Despite the common use of nutritional support during radiotherapy, current randomized trials indicate that routine nutritional intervention does not significantly improve treatment response, local control, survival rates, or reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional support as an adjunct to radiation therapy. Donaldson, SS.[2017]

In a study of 208 patients with locally advanced pancreatic adenocarcinoma treated with stereotactic body radiotherapy (SBRT), low albumin levels and a high neutrophil-lymphocyte ratio (NLR>5) were associated with decreased survival, highlighting the importance of nutritional status and inflammation in prognosis.

Patients with better nutritional markers (higher albumin and lower NLR) and those receiving chemotherapy showed improved overall survival, suggesting that addressing nutritional deficiencies and inflammation could enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Albumin and Neutrophil-Lymphocyte Ratio (NLR) Predict Survival in Patients With Pancreatic Adenocarcinoma Treated With SBRT. Alagappan, M., Pollom, EL., von Eyben, R., et al.[2023]

A study involving 130 prostate cancer patients undergoing radiotherapy found that a dietary intervention aimed at reducing insoluble dietary fibers and lactose did not significantly impact gastrointestinal side effects or health-related quality of life (HRQOL) over a 2-month period after treatment.

While the intervention group reported a lower percentage of bowel symptoms compared to the standard care group, these differences were not statistically significant, suggesting that more research is needed to determine the true effects of dietary changes on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: a randomized controlled trial in prostate cancer patients undergoing radiotherapy. Pettersson, A., Johansson, B., Persson, C., et al.[2018]

Citations

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