Bladder CancerEarly Phase 1NCT01868087
Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study
A Early Phase 1 study testing Boost Plus® and Impact Advanced Recovery® in people with Bladder Cancer and Radical Cystectomy, run by Jill Hamilton-Reeves, PhD RD LD at 1 site in United States.
Trial summary
The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications. Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms
- What is being tested?
- Boost Plus® and Impact Advanced Recovery®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men undergoing RC surgery for primary bladder cancer
Who cannot join
- Patients with swallowing difficulties or unable to tolerate oral intake
- Evidence of metastatic disease
- Weight loss ≥ 10% (with respect to usual body weight) in the 6 months prior to surgery or BMI ≤ 18.5
- Patients undergoing cystectomy for non-bladder primary malignancy or cancer type other than urothelial
- Active viral infections such as Human immunodeficiency virus (HIV) positive, hepatitis, or who have a known immunodeficient state
- Prior history of gouty arthritis or uric acid stones
- Patients with milk, soy, or fish allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Impact Advanced Recovery® for Radical Cystectomy (RC) Patients
The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.
Read the detailed description
Radical cystectomy (RC) is the removal of the entire bladder and nearby organs that may contain cancer cells. It is a major surgery that can lead to breakdown of proteins in the body and a decreased immune response, both of which increase the risk of illness and death. Poor nutrition status before RC surgery is linked to a higher rate of death after surgery. Therefore, it is important to eat a balanced diet before and after RC surgery to avoid negative outcomes.
Studies show that patients who drink a nutritional supplement that may enhance the immune system before and after gastro-intestinal surgery may have fewer infections and shorter hospital stays after surgery. Patients with cancer of the colon/rectum, stomach, and pancreas who drank a similar immune-enhancing nutritional supplement before and after surgery also had fewer infections.
The purpose of this study is to attain pilot data for a larger trial.
- Conditions
- Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms, Surgery
- Being tested
- Boost Plus®, Impact Advanced Recovery®
- Keywords
- nutritional supplement, immune system, RC surgery
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost Plus®Dietary supplement
Impact Advanced Recovery®Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Impact Advanced Recovery® | Experimental | 3 briks daily (240 mL per brik) of Impact Advanced Recovery® to be take for 5 days before and after RC surgery Receives: Dietary Supplement: Impact Advanced Recovery® |
| Boost Plus® | Placebo comparator | 3 briks daily (240 mL per brik) of Boost Plus® to be take for 5 days before and after RC surgery Receives: Dietary Supplement: Boost Plus® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune and Inflammation Response
Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.
Measured: Change from Baseline to Day 30
Secondary outcomes (3)
preservation of body weight and fat free mass (FFM)
measure of body weight and fat free mass between groups over course of the study
Measured: Change from Baseline to 30 Days
count of infections after surgery
count of total number of infections affecting study participants
Measured: Change from Baseline to 30 Days
hospital readmission rate
readmissions required for study partipants
Measured: Change from Baseline to 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jill Hamilton-Reeves, PhD RD LD
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Société des Produits Nestlé (SPN)
- Responsible party
- Sponsor-investigator, Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center
- Investigators
- Jill Hamilton-Reeves, PhD, RD, LD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868087
- Sponsor's protocol ID
- 13730
- Status last verified
- Oct 2024
- First submitted
- 29 May 2013
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamilton-Reeves JM, Bechtel MD, Hand LK, Schleper A, Yankee TM, Chalise P, Lee EK, Mirza M, Wyre H, Griffin J, Holzbeierlein JM. Effects of Immunonutrition for Cystectomy on Immune Response and Infection Rates: A Pilot Randomized Controlled Clinical Trial. Eur Urol. 2016 Mar;69(3):389-92. doi: 10.1016/j.eururo.2015.11.019. Epub 2015 Nov 30.
PubMed 26654125
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Advanced Recovery® for Radical Cystectomy (RC) Patients
- ClinicalTrials.gov ID
- NCT01868087
- Acronym / sponsor ID
- 13730
- Conditions
- Bladder Cancer, Radical Cystectomy, Urinary Bladder Neoplasms, Surgery
- Keywords
- nutritional supplement, immune system, RC surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jill Hamilton-Reeves, PhD RD LDUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Société des Produits Nestlé (SPN)
- Study start
- Jul 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.
Detailed description
Radical cystectomy (RC) is the removal of the entire bladder and nearby organs that may contain cancer cells. It is a major surgery that can lead to breakdown of proteins in the body and a decreased immune response, both of which increase the risk of illness and death. Poor nutrition status before RC surgery is linked to a higher rate of death after surgery. Therefore, it is important to eat a balanced diet before and after RC surgery to avoid negative outcomes.
Studies show that patients who drink a nutritional supplement that may enhance the immune system before and after gastro-intestinal surgery may have fewer infections and shorter hospital stays after surgery. Patients with cancer of the colon/rectum, stomach, and pancreas who drank a similar immune-enhancing nutritional supplement before and after surgery also had fewer infections.
The purpose of this study is to attain pilot data for a larger trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impact Advanced Recovery® | Experimental | Dietary Supplement: Impact Advanced Recovery®3 briks daily (240 mL per brik) of Impact Advanced Recovery® to be take for 5 days before and after RC surgery |
| Boost Plus® | Placebo comparator | Dietary Supplement: Boost Plus®3 briks daily (240 mL per brik) of Boost Plus® to be take for 5 days before and after RC surgery |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men undergoing RC surgery for primary bladder cancer
Key exclusion criteria (7 listed)
- Patients with swallowing difficulties or unable to tolerate oral intake
- Evidence of metastatic disease
- Weight loss ≥ 10% (with respect to usual body weight) in the 6 months prior to surgery or BMI ≤ 18.5
- Patients undergoing cystectomy for non-bladder primary malignancy or cancer type other than urothelial
- Active viral infections such as Human immunodeficiency virus (HIV) positive, hepatitis, or who have a known immunodeficient state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boost Plus® | Dietary supplement | Boost Plus® |
| Impact Advanced Recovery® | Dietary supplement | Impact Advanced Recovery® |
Primary outcome
Immune and Inflammation Response
Time frame: Change from Baseline to Day 30
Measure ability of Impact Advanced Recovery® to alter body's immune and inflammation response.
3 secondary outcomes
preservation of body weight and fat free mass (FFM)
Time frame: Change from Baseline to 30 Days
count of infections after surgery
Time frame: Change from Baseline to 30 Days
hospital readmission rate
Time frame: Change from Baseline to 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Results publication: PubMed 26654125Hamilton-Reeves JM, Bechtel MD, Hand LK, Schleper A, Yankee TM, Chalise P, Lee EK, Mirza M, Wyre H, Griffin J, Holzbeierlein JM. Effects of Immunonutrition for Cystectomy on Immune Response and Infection Rates: A Pilot Randomized Controlled Clinical Trial. Eur Urol. 2016 Mar;69(3):389-92. doi: 10.1016/j.eururo.2015.11.019. Epub 2015 Nov 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Hamilton-Reeves, PhD, RD, LD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Boost Plus® and Impact Advanced Recovery® in people with Bladder Cancer and Radical Cystectomy, run by Jill Hamilton-Reeves, PhD RD LD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune and Inflammation Response (time frame: Change from Baseline to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.