NCT00497380

Brief Summary

Muscle catabolism is a major problem in cancer patients undergoing surgery as it negatively affects post-operative recovery. Recent evidence exists that protein metabolic changes are already apparent in cancer before muscle wasting is being present. In line, patients with breast cancer, generally characterized by a normal nutritional status, were recently found to be arginine deficient. Arginine deficiency in cancer can be explained by: 1) Reduced arginine availability, due to exhaustion of endogenous (muscle) sources of arginine 2) Enhanced arginine catabolism, due to conversion of arginine by arginase, which is abundant in tumors. Protein is the most important endogenous source of arginine. Arginine deficiency will lead to a negative feedback loop in cachexia by promoting protein breakdown in an attempt to restore plasma arginine levels. We hypothesize that pre-operative arginine supplementation in breast cancer patients diminishes the occurrence of muscle wasting after surgery by 1) normalizing arginine availability pre-operatively, resulting in conservation of protein, 2) diminishing the catabolic effects of surgery by supplying exogenous arginine for the post-operative response, 3) enhancing the anabolic capacity to feeding through supplying substrate for protein synthesis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 18, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2012

Completed
Last Updated

September 30, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

July 5, 2007

Last Update Submit

September 26, 2025

Conditions

Protein Metabolism

Outcome Measures

Primary Outcomes (1)

  • Net protein balance

    end of study

Secondary Outcomes (1)

  • Arginine turnover

    end of study

Study Arms (2)

Arginine enriched nutrition

EXPERIMENTAL
Dietary Supplement: Arginine

Nutrition

PLACEBO COMPARATOR
Dietary Supplement: Arginine

Interventions

ArginineDIETARY_SUPPLEMENT

Oral nutritional supplement

Arginine enriched nutritionNutrition

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer groups (for aims 1 and 2)
  • Recently diagnosed (up to 4 weeks prior to treatment for cancer) with stage I, II or III invasive breast cancer
  • Undergoing mastectomy
  • Age greater than 30 years
  • Ability to sign informed consent
  • Good performance status defined by ECOG scale 0,1 or 2 (see CRF performance status)
  • Control group (for aim 1)
  • Age greater than 30 years
  • Undergoing prophylactic mastectomy
  • Ability to sign informed consent
  • Good performance status defined by ECOG scale 0,1 or 2 (see CRF performance status)

You may not qualify if:

  • All groups (aim 1 and 2)
  • Body weight loss of greater than 10% in the past 3 months
  • Previous anti-cancer therapy (e.g. chemotherapy or radiotherapy) or surgery less than 4 weeks prior to the experiment
  • Diagnosed diabetes type I or II
  • Untreated metabolic diseases including liver or renal disease
  • Any documented autoimmune disease
  • Use of corticosteroids, beta-antagonists or nitrovasodilators
  • Use of supplements enriched with amino acids
  • Presence of acute illness or metabolically unstable chronic illness
  • Unstable heart disease requiring therapy or recent myocardial infarction (less than 1 year)
  • Current alcohol or drug abuse (ETOH more than 2 servings per day)
  • Allergy/intolerance to any of the ingredients of the study products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

  • Engelen MPKJ, Klimberg VS, Allasia A, Deutz NEP. Major surgery diminishes systemic arginine availability and suppresses nitric oxide response to feeding in patients with early stage breast cancer. Clin Nutr. 2018 Oct;37(5):1645-1653. doi: 10.1016/j.clnu.2017.07.019. Epub 2017 Aug 5.

    PMID: 28826699DERIVED

MeSH Terms

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Nicolaas Deutz, M.D., Ph.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

August 18, 2009

Primary Completion

February 4, 2012

Study Completion

February 4, 2012

Last Updated

September 30, 2025

Record last verified: 2025-09

Locations

US(1)