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

Trial Summary

What is the purpose of this trial?

Standard planning constraints for liver SBRT incorporate strict dose-volume limits for normal liver parenchyma to minimize the risk of radiation-induced liver disease. The presence of diurnal and fasting/fed variations in liver volume therefore carry substantial potential for introducing errors into estimates of dose-volume distribution within normal liver tissue, as well as affecting day-to-day setup fidelity and organ alignment for treatment. This prospective study will examine how diurnal and fast-fed variations in liver volume affect treatment planning for abdominal SBRT.

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 data supports the effectiveness of the treatment Standardized high-carbohydrate meal for liver cancer?

There is no direct evidence from the provided research articles supporting the effectiveness of a standardized high-carbohydrate meal specifically for liver cancer. However, nutritional support in general is noted to be beneficial for patients undergoing radiation therapy, especially if they are malnourished, although no specific benefits in terms of improved treatment response or survival rates have been conclusively shown. ^{1 2 3 4 5}

Is the standardized high-carbohydrate meal safe for humans?

The research articles discuss nutritional interventions during radiotherapy, indicating that nutritional support is generally safe and often used to help patients undergoing radiation treatment. However, specific safety data for a standardized high-carbohydrate meal is not directly addressed in these studies. ^{3 5 6 7 8}

How does the meal impact treatment for liver cancer differ from other treatments?

This treatment is unique because it explores how meals can affect the planning and effectiveness of radiation therapy for liver cancer, which is not a standard approach. Unlike typical treatments that focus solely on radiation or chemotherapy, this study considers the role of diet in enhancing treatment outcomes. ^{1 5 7 9 10}

Research Team

Susannah Ellsworth, MD

Principal Investigator

UPMC Hillman Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The impact of dietary regimen compliance on outcomes for HNSCC patients treated with radiation therapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Albumin and Neutrophil-Lymphocyte Ratio (NLR) Predict Survival in Patients With Pancreatic Adenocarcinoma Treated With SBRT. [2023]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Validation of the Malnutrition Universal Screening Tool (MUST) in cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Ireland 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. [2018]

7. Ireland 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. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Nutritional consequences of radiotherapy. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Dietary enhancement of intestinal radioresistance during fractionated irradiation. [2007]

10. Germany pubmed.ncbi.nlm.nih.gov

Impact of the antifermentative diet during radiotherapy for prostate cancer in elderly, SÃO Paulo, Brazil. [2021]