What side effects are associated with this type of intervention?

Common treatments for malnutrition, such as multimodal nutrition therapy, often involve oral nutritional supplements, appetite stimulants, and enteral feeding. Oral nutritional supplements can cause gastrointestinal issues like nausea, diarrhea, and bloating. Appetite stimulants, such as megestrol acetate, may lead to side effects including weight gain, edema, and thromboembolic events. Enteral feeding can result in complications like tube displacement, infections, and gastrointestinal discomfort. It is important to monitor patients closely to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for malnutrition, particularly in the context of cancer treatment. These include nutritional supplements like oral nutritional supplements (ONS) and enteral nutrition formulas designed to provide balanced nutrition and optimize caloric intake. Pharmacologic agents such as megestrol acetate have been approved to stimulate appetite and increase weight in patients with cancer-related cachexia. Additionally, therapies like parenteral nutrition are used when oral or enteral feeding is not feasible. These treatments align with the multimodal nutrition therapy approach, which combines primary nutrition intervention with adjuvant therapies to support patients' nutritional needs during cancer treatment.

What other types of research exist?

Promising novel alternatives to Multimodal Nutrition Therapy for malnutrition in cancer patients include: 1) Ghrelin and its mimetics like anamorelin, which have shown potential in increasing appetite and caloric intake. 2) Exercise interventions, particularly progressive resistance training, which can improve body composition and nutritional status. 3) Pharmacological agents such as melatonin and cyproheptadine, which have been studied for their effects on appetite and weight gain. These alternatives should be discussed with a healthcare provider to tailor the best approach for individual patient needs.

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Other

Resource® Support Plus for Malnutrition in Head and Neck Cancer Patients

Phase 2

Waitlist Available

Led By Vickie Baracos

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy

An Eastern Cooperative Oncology Group Performance Status of ≤ 2

Must not have

Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis)

Fed by nasogastric tube, gastrostomy or total parenteral nutrition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days prior to start of treatment, week 14

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special diet plan to help head and neck cancer patients eat enough. The diet includes two types of medical foods designed to provide necessary calories and nutrients, making it easier for patients to maintain their energy levels.

Who is the study for?

This trial is for adults over 18 with squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx planning to undergo radical radiotherapy. They must be able to eat orally and have a performance status indicating they can carry out some activity. Excluded are those with certain other cancers, on conflicting trials, using tube feeding, having conditions affecting nutrient metabolism/absorption, untreated brain metastases, severe chronic illnesses or allergies to trial supplement ingredients.

What is being tested?

The study tests if multimodal nutrition therapy helps patients maintain their calorie intake during cancer treatment. It compares the average energy consumed by patients receiving primary nutrition intervention plus adjuvant therapy (Resource® Support Plus) against a control group throughout their treatment period.

What are the potential side effects?

Potential side effects may relate to allergic reactions due to ingredients in Resource® Support Plus such as milk/lactose or fish. Since it's nutritional support rather than medication being tested here, fewer side effects are expected compared to drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a confirmed diagnosis of squamous cell carcinoma in the mouth or throat area and will undergo intensive radiotherapy.

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I can perform daily activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any poorly controlled chronic illnesses like COPD, diabetes, or rheumatoid arthritis.

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I am fed through a tube or IV nutrition.

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My cancer is in the nasopharynx, thyroid, or salivary gland.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days prior to start of treatment, week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days prior to start of treatment, week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days prior to start of treatment, week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in mean cumulative energy intake

Secondary study objectives

Change in Nutritional blood biomarkers

Change in body weight (kg)

Change in computed-tomography (CT) defined skeletal muscle and fat mass)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal Nutrition TherapyExperimental Treatment1 Intervention

To assess a multimodal nutrition therapy (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient). Resource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition. BOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and/or radiotherapy.

Group II: Standard of CareActive Control1 Intervention

In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for malnutrition, particularly in the context of multimodal nutrition therapy, work by optimizing total caloric intake and improving nutrient absorption. Primary nutrition intervention focuses on providing a balanced diet rich in essential nutrients, while adjuvant nutrition therapy may include supplements or specialized feeding techniques to ensure adequate energy intake. These treatments are crucial for malnutrition patients as they help address the root causes of inadequate nutrition, support metabolic function, and enhance the body's ability to recover and maintain health during periods of increased physiological stress, such as cancer treatment.