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Prostate CancerCLIPP2NCT04228055

Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2 (CLIPP2)

A study testing CLIPP2 in people with Prostate Cancer, run by University of Arizona at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 36 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle… Read more about this study

Who is it for?
Ages 40 to 80 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
CLIPP2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesUnited States
Study dates
7 Aug 2020to 31 Oct 2022
Phase
Interventional
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 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with prostate cancer Stage I, II or III
  • On androgen deprivation therapy with last 5 years
  • Willing to participate in a lifestyle modification program
  • Willing to modify diet and eating practices
  • Willing to participate in blood collection, urine collection and measurements
  • Minimum of 30 days since participating in another study/trial
Show all 9Show fewer
  • English speaking
  • 40 to 80 years of age
  • BMI >25%

Who cannot join

  • Currently participating in another study or trial
  • Currently in hospice
  • Inability to walk two city blocks
  • Inability to comprehend informed consent or procedural requirements
  • Digestive Diseases (IBD, Diverticulitis, etc) that might prevent him from increasing fruit and vegetable intake
  • Subjects already following an intensive lifestyle modification plan
  • BMI <25%

Trial locations and contacts

2 sites in 1 country.

Tracey Smith contact

5206268038

traceysmith@email.arizona.edu

Amit Algotar, MD, PhD, MPH contact

5206268038

algotar@email.arizona.edu

United States2 sites, 2 recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Tracey Smith, 520-626-8038, traceysmith@arizona.edu

    Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona, 85714

    Tracey Smith, 520-626-8038, traceysmith@email.arizona.edu

    Amit Algotar, MD

    Not yet recruiting

Other trials in United States

About this study

This study is an investigator initiated clinical study. A prospective, single arm unblinded, open label study will be carried out to determine the feasibility of recruitment, retention and adherence of 36 prostate cancer survivors who have been on androgen deprivation therapy within the last 5 years for a lifestyle modification intervention.

Read the detailed description

INTRODUCTION:

Androgen deprivation therapy (ADT) has been demonstrated to improve disease free and over-all survival in men with prostate cancer (PCa).

ADT for PCa is associated with adverse cardio-metabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction and stroke. This reduces quality of life (QoL) and potentially affects mortality.

There is paucity of data regarding comprehensive lifestyle interventions in men on ADT for Pca. Existing studies used non-standardized interventions or lack data on metabolic risk factors.

CLIPP is designed to address these gaps by using an intervention modelled after the Diabetes Prevention Program (DPP) with an emphasis on low carbohydrate and a Keto Diet, a standardized multi-component intervention with demonstrated effectiveness in reducing diabetes risk factors that has been successfully adapted for multiple disease types including breast cancer.

INTERVENTION:

  • 24 Weeks
  • Health Coaching Weekly
  • Serum \& Urine Baseline, Week 12 and Week 24
  • Anthropometric Measures
  • Questionnaires
  • BMI Measurements
Conditions
Prostate Cancer
Being tested
CLIPP2
Keywords
Low Carbohydrate, Ketogenic, Androgen Deprivation Therapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLIPP2Behavioural

    Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.

Study groups in NCT04228055
Study groupRoleWhat they receive
CLIPP2Experimental24 Week Lifestyle Modification Intervention
Receives: Behavioral: CLIPP2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reach Recruiting Target

    Recruit 36 men with prostate cancer who have been on androgen deprivation therapy within the last 5 years.

    Measured: 6 Months

  2. Retention of Participants

    75% retention rate

    Measured: 6 Months

  3. Adherence to Intervention

    75% attendance rate throughout 24 intervention visits

    Measured: 6 Months

Secondary outcomes (7)

  1. Fasting Glucose

    Unit of Measure Mg/dL

    Measured: 6 Months

  2. Lipid Panel

    Unit of Measure Mg/dl

    Measured: 6 Months

  3. Hemoglobin A1c

    Unit of Measure %

    Measured: 6 Months

  4. CBC

    Unit of Measure Mg/dL

    Measured: 6 Months

  5. CMP

    Unit of Measure Mg/dL

    Measured: 6 Months

  6. Global Quality of Life Questionnaire

    PROMIS Scale v 1.2 Global Health. Scale Measurements 1 to 5 1=Poor 5=Excellent

    Measured: 6 Months

  7. Specific Quality of Life Questionnaire

    Expanded Prostate Cancer Index Composite Short Form (EPIC-26) Scale of Measurement 0 to 4. 0=No Problem 4=Big Problem

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2020
  2. Study start7 Aug 2020
  3. Primary completion28 Feb 2022 (estimated)
  4. Study completion31 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Pre and Post Study Model
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04228055
Sponsor's protocol ID
1806697620-2
Acronym
CLIPP2
Status last verified
Aug 2021
First submitted
10 Jan 2020
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Algotar AM, Kumar R, Babiker HM, Dougherty ST, Hsu CH, Chow HH, Smith TE, Marrero DG, Courneya KS, Abraham I, Ligibel JA, Thomson CA. Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2). Contemp Clin Trials Commun. 2021 Jan 13;21:100701. doi: 10.1016/j.conctc.2021.100701. eCollection 2021 Mar.

    PubMed 33511299

Questions about this trial

What is this clinical trial studying?

A study testing CLIPP2 in people with Prostate Cancer, run by University of Arizona at 2 sites 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 9 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tracey Smith (5206268038, traceysmith@email.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach Recruiting Target (time frame: 6 Months). The study lists 3 primary outcomes in all. 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 NCT04228055, 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 31 Aug 2021.

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