Exercise for Prostate Cancer Patients

NCT00815672 | Completed DMC

• 1 other identifier: 1703DOD
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gain a better understanding of the mechanisms responsible for cancer-related fatigue.

Conditions

Fatigue

Keywords

Exercise; Prostate cancer; Fatigue

Outcome Measures

Primary Outcomes (1)

• Cancer-related fatigue

  The primary outcome measure for this study is CRF assessed by the FACIT-F fatigue subscale at the end of the 6th calendar week of the study.

  4.5 Months

Secondary Outcomes (6)

• To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Strength

  4.5 months

• To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Skeletal Muscle Mass

  4.5 months

• To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: QOL

  4.5 months

• To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Sleep Quality

  4.5 months

• To provide preliminary data on influence of home-based aerobic and resistance exercise on the following: Self Esteem

  4.5 months

Study Arms (2)

Treatment Arm 1

NO INTERVENTION

Usual Care: Standard care monitoring

Treatment arm 2

EXPERIMENTAL

Home-based Exercise: Progressive walking and resistance exercise treatment.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Progressive walking and resistance exercise treatment

Treatment arm 2

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a primary diagnosis of prostate cancer
• Have a KPS of 60 or greater.
• Be receiving any form of treatment for their prostate cancer or have received some form of treatment (e.g. surgery, chemotherapy, radiation therapy, hormone therapy) in the last 10 years
• Have approval of physician and be able to read English.
• Be 21 years of age or older and give informed consent

You may not qualify if:

• Have bone metastases that preclude participation due to symptoms such as pain or location of the bone metastasis.
• Have physical limitations that contraindicate participation.

Sponsors & Collaborators

• University of Rochester: lead
• United States Department of Defense: collaborator

Study Sites (1)

James P. Wilmot Cancer Center, University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Fatigue; Motor Activity; Prostatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karen Mustian, Ph.D.

  James P. Wilmot Cancer Center, University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 29, 2008
• First Posted: December 30, 2008
• Study Start: December 1, 2007
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 28, 2019

Record last verified: 2018-11

Locations

US (1)