Anabolic Response Cancer
| Status: | Withdrawn |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2016 |
| End Date: | May 2019 |
Assessment of Anabolic Responsiveness to Protein Intake in Advanced Cancer
Weight loss and muscle wasting commonly occurs in patients with cancer, negatively
influencing their quality of life, treatment response and survival. Weight changes in
patients with cancer may be the consequence of energy imbalance and disturbances in protein
metabolism, poor treatment tolerance, hormonal alterations, systemic inflammation etc. This
results in body composition modifications in favor of fat gain and/or lean body mass loss in
early stage cancer. However, in advanced cancer mostly loss of both fat mass and lean mass
has been found.
Unfortunately, gains in muscle mass are difficult to achieve. In a previous study of the
Investigators, a bolus (15 g) of an essential amino acid mixture as present in milk protein
was able to stimulate whole-body protein anabolism equally and effectively in weight-losing
patients with lung cancer. This indicates the high potential of proteins with high essential
amino acids as therapeutic agents to increase muscle mass in these patients. However, the
dose-response effect to reach optimal whole-body protein anabolism is yet unknown and can
differ among patients. Therefore, the Investigators would like to study the effects of
several dosages of a protein with high essential amino acid levels, administered by sip
feeding, on whole-body protein anabolism in patients with cancer in comparison with healthy
older adults. Furthermore, the individual protein requirements of cancer patients may be
established as this is the cornerstone of nutritional support. Specifically to establish 'the
anabolic threshold', when protein breakdown equals synthesis and the response and the
relation between protein intake and net protein synthesis are critical.
influencing their quality of life, treatment response and survival. Weight changes in
patients with cancer may be the consequence of energy imbalance and disturbances in protein
metabolism, poor treatment tolerance, hormonal alterations, systemic inflammation etc. This
results in body composition modifications in favor of fat gain and/or lean body mass loss in
early stage cancer. However, in advanced cancer mostly loss of both fat mass and lean mass
has been found.
Unfortunately, gains in muscle mass are difficult to achieve. In a previous study of the
Investigators, a bolus (15 g) of an essential amino acid mixture as present in milk protein
was able to stimulate whole-body protein anabolism equally and effectively in weight-losing
patients with lung cancer. This indicates the high potential of proteins with high essential
amino acids as therapeutic agents to increase muscle mass in these patients. However, the
dose-response effect to reach optimal whole-body protein anabolism is yet unknown and can
differ among patients. Therefore, the Investigators would like to study the effects of
several dosages of a protein with high essential amino acid levels, administered by sip
feeding, on whole-body protein anabolism in patients with cancer in comparison with healthy
older adults. Furthermore, the individual protein requirements of cancer patients may be
established as this is the cornerstone of nutritional support. Specifically to establish 'the
anabolic threshold', when protein breakdown equals synthesis and the response and the
relation between protein intake and net protein synthesis are critical.
In this study, the Investigators will test the following hypothesis: A protein meal with high
EAA levels will stimulate protein anabolism in a dose-dependent way but the exact
relationship differs among cancer patients. The primary endpoint will be the extent of
stimulation of net whole-body protein synthesis at each level of protein intake in the
individual cancer and control subject. This project will provide important clinical
information on the anabolic capacity of dietary protein with high EAA levels and the level of
protein intake required to become anabolic in cancer patients on an individual bases. In this
way, this study will provide preliminary data for the development of individualized
nutritional strategies that will stop the process of ongoing muscle loss in cancer patients.
General aims:
- To study the whole-body protein anabolic effect of several dosages of a high-quality
protein sip feeding in cancer subjects as compared to healthy controls.
- To investigate the anabolic threshold in subjects with cancer as compared to healthy
controls.
The mechanisms underlying lean tissue loss in cancer remain to be unraveled, which may be
because of the complexity of the metabolic alterations that are present when symptoms such as
weight loss become obvious. Multiple factors like anorexia and inflammation are present in
cancer, all contributing to the loss of lean tissue in these patients by creating a drain on
the body protein stores. Previous studies showed that oral supplementation of large amounts
of calories in cancer is only partially successful and this indicates that the composition of
dietary supplements and meals is important to successfully counteract muscle wasting.
Although our previous study supports the concept of supplementing high-quality milk proteins
in lung cancer subjects, the dose-response anabolic effects of proteins with high EAA levels
are still unclear. Furthermore, there is no insight in the actual protein requirements in
cancer. The knowledge gained from this study will benefit our insight in terms of promotion
of protein gain after feeding in cancer patients.
EAA levels will stimulate protein anabolism in a dose-dependent way but the exact
relationship differs among cancer patients. The primary endpoint will be the extent of
stimulation of net whole-body protein synthesis at each level of protein intake in the
individual cancer and control subject. This project will provide important clinical
information on the anabolic capacity of dietary protein with high EAA levels and the level of
protein intake required to become anabolic in cancer patients on an individual bases. In this
way, this study will provide preliminary data for the development of individualized
nutritional strategies that will stop the process of ongoing muscle loss in cancer patients.
General aims:
- To study the whole-body protein anabolic effect of several dosages of a high-quality
protein sip feeding in cancer subjects as compared to healthy controls.
- To investigate the anabolic threshold in subjects with cancer as compared to healthy
controls.
The mechanisms underlying lean tissue loss in cancer remain to be unraveled, which may be
because of the complexity of the metabolic alterations that are present when symptoms such as
weight loss become obvious. Multiple factors like anorexia and inflammation are present in
cancer, all contributing to the loss of lean tissue in these patients by creating a drain on
the body protein stores. Previous studies showed that oral supplementation of large amounts
of calories in cancer is only partially successful and this indicates that the composition of
dietary supplements and meals is important to successfully counteract muscle wasting.
Although our previous study supports the concept of supplementing high-quality milk proteins
in lung cancer subjects, the dose-response anabolic effects of proteins with high EAA levels
are still unclear. Furthermore, there is no insight in the actual protein requirements in
cancer. The knowledge gained from this study will benefit our insight in terms of promotion
of protein gain after feeding in cancer patients.
Inclusion criteria cancer subjects:
- Age 18 years or older
- Ability to lie in supine or elevated position for 8 hours
- Diagnosed with stage III/IV cancer (all solid tumors excluding breast or prostate)
- No chemotherapy/radiotherapy within past month prior to the study day
- Willingness and ability to comply with the protocol
Inclusion criteria healthy subjects:
- Healthy male or female according to the investigator's or appointed staff's judgment
- Age 18 years or older
- Ability to lay in supine or elevated position for 8 hours
- No diagnosis of cancer
- No diagnosis of diabetes
- Willingness and ability to comply with the protocol
Exclusion Criteria all subjects:
- Any condition that may interfere with the definition 'healthy subject' according to
the investigator's judgment (for healthy control group only)
- Presence of fever within the last 3 days
- Untreated metabolic diseases including hepatic or renal disorder
- Presence of acute illness or metabolically unstable chronic illness
- BMI of < 18.5 or ≥ 35 kg/m2 (for healthy control group only)
- Dietary or lifestyle characteristics: Current alcohol or drug abuse, Use of protein or
amino acid containing nutritional supplements within 5 days prior to the study day
- Known allergy to milk or milk products
- Failure to give informed consent or Investigator's uncertainty about the willingness
or ability of the subject to comply with the protocol requirements
- (Possible) pregnancy
- Any other condition according to the PI or nurse that was found during the screening
visit, that would interfere with the study or safety of the patient
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