Evidence map›Paper›PMID 33511299›Full record

ArticleContemporary clinical trials communications2021

Protocol for a feasibility and early efficacy study of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2).

A M Algotar, R Kumar, H M Babiker, S T Dougherty, C H Hsu, H-H Chow, T E Smith, D G Marrero, K S Courneya, I Abraham and 2 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04228055 (Comprehensive Lifestyle Improvement Program for Men With Prostate Cancer2), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.1field-weighted citation impact, top 53% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04228055 naunknown statusnot on this map

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

TypeinterventionalSponsorUniversity of ArizonaRan2020 to 2022Enrolled36ConditionsProstate CancerArmsCLIPP2
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 2 countries.

A M AlgotarDepartment of Family and Community Medicine, University of Arizona, USA.
R KumarRadiation Oncology, Banner MD Anderson Cancer Center, USA.
H M BabikerThe University of Arizona Cancer Center, USA.
S T DoughertyThe University of Arizona Cancer Center, USA.
C H HsuThe University of Arizona Cancer Center, USA.
H-H ChowThe University of Arizona Cancer Center, USA.
T E SmithDepartment of Family and Community Medicine, University of Arizona, USA.
D G MarreroDepartment of Health Promotion Science, Mel and Enid College of Public Health, University of Arizona, USA.
K S CourneyaFaculty of Kinesiology, Sport, and Recreation, University of Alberta, Canada.
I AbrahamDepartment of Family and Community Medicine, University of Arizona, USA.
J A LigibelDana Farber Cancer Institute, Harvard Medical School, USA.
C A ThomsonThe University of Arizona Cancer Center, USA.
University of Arizona · USUniversity of Arizona Cancer CenterBanner MD Anderson Cancer CenterDana-Farber Cancer Institute · USUniversity of Alberta · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough androgen deprivation therapy (ADT) for prostate cancer demonstrates improved overall and disease-free survival, it is associated with adverse effects such as obesity and metabolic syndrome that increase risk of cardiometabolic disease and diabetes type 2. ADT also leads to fatigue, depression and erectile dysfunction, which reduce quality of life (QoL). Lifestyle modification has shown promise in reducing obesity, metabolic syndrome and diabetes type 2 in other disease types. However, there is a paucity of data regarding the utility of lifestyle modification in men receiving ADT for prostate cancer.

methodsThe primary aim of the Comprehensive Lifestyle Improvement Program for Prostate Cancer-2 (CLIPP2) is to test the feasibility of conducting a 24-week lifestyle modification intervention in men on ADT for prostate cancer. Additionally, it will also determine the effect of this intervention on weight loss, cardiometabolic markers (secondary aim and markers of interest: serum glucose, insulin resistance, hemoglobin A1C and lipid panel), and QoL (tertiary aim). The intervention will be delivered weekly via telephone for the first 10 weeks and bi-weekly for the remaining 14 weeks. Questionnaires and serum samples will be collected at baseline, week 12, and week 24. Anthropometric measurements will be collected at baseline, week 6, week 12, week 18 and week 24.

resultsWe hypothesize that the CLIPP2 intervention will produce a 7% weight loss that will result in improved markers associated with cardiometabolic disease and type 2 diabetes in the study population.

conclusionResults will provide insight into the role of lifestyle modification in addressing ADT adverse effects as well as provide preliminary data to inform the development of future lifestyle interventions in this area.

trial registrationNCT04228055 Clinicaltrials. gov.

Indexed as

Androgen Deprivation TherapyLifestyle ModificationProstate Cancer

Identifiers

PMID33511299
PMCPMC7815988
OpenAlexW3119598919

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.