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PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO) (PROSCARDIO)

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Standard care plus exercise

About this trial

This is an interventional prevention trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen deprivation therapy, Exercise

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Male
Aged 50 to 80 years
Histologically confirmed stage I-IV prostate cancer
Scheduled for treatment with a luteinizing hormone-releasing hormone (LHRH) agonist either alone or combined with radiotherapy
Anticipated to remain on androgen deprivation therapy (ADT) for at least the next 6 months
Willing and able to give written informed consent.
Understand written and verbal instructions in English
World Health Organisation (WHO) performance status 0 to 1

Exclusion Criteria:

Previously treated with ADT
Diagnosed or suspected metastatic bone disease
Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine (ACSM, 2010)
Prior myocardial infarction or heart failure
Chronic obstructive pulmonary disease (COPD)
Poorly controlled hypertension (≥ 200/110 mmHg)
Uncontrolled supraventricular tachycardia (≥ 100 bpm)
Pre-existing severe musculoskeletal, neurological or psychiatric condition that may affect their ability to complete the testing battery or exercise training, as determined by the patient's physician
Involvement in any other clinical trial or exercise trial

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Standard care plus exercise

Arm Description

This group did not receive any supervised exercise or were not given any specific exercise recommendations during the trial period. However, patients in this group were offered the exercise intervention after completing the study.

This group received standard care in addition to a 3-month exercise intervention upon initiating androgen deprivation therapy.

Outcomes

Primary Outcome Measures

Whole body fat mass (kg)

Whole body fat mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This was chosen as the primary outcome because adiposity has shown a high propensity to increase during the initial phases of androgen deprivation therapy, more so than other measures (Galvao et al. 2011), which highlights the importance of targeting body fat at this stage of treatment.

Secondary Outcome Measures

Whole body fat mass (kg)

Whole body fat-free mass (kg)

Whole body fat-free mass was measured with bioelectrical impedance analysis (BIA) and concurrent bioelectrical impedance vector analysis (BIVA) with a single-frequency, phase-sensitive 50 kilohertz bioelectrical impedance analyzer (BIA-101, RJL/Akern Systems, Florence, Italy). This method is highly valid for measuring changes in body composition (Savastano et al. 2010).

Anthropometric measurements (cm)

Waist, hip, mid-upper arm, forearm, mid-thigh and calf circumferences were measured with a non-stretching tape using standard techniques.

Peak oxygen consumption (VO2peak, ml/kg/min)

Determined as the highest oxygen consumption (V̇O2) attained during the cardiopulmonary exercise test

Ventilatory anaerobic threshold (ml/kg/min)

Estimated using the modified V-slope method and confirmed by evaluating ventilatory equivalents and end-tidal pressures. Two analysts independently determined the ventilatory anaerobic threshold, with discrepancies of ≥ 7.5% resolved through discussion and consultation with a third analyst if necessary.

Ventilatory equivalents for O2 (V̇E/V̇O2) and CO2 (V̇E/V̇CO2)

Ratio of minute ventilation to O2 consumption and CO2 output at the ventilatory anaerobic threshold

Oxygen pulse (ml/beat)

Ratio of oxygen consumption to heart rate at peak exercise during the cardiopulmonary exercise test

Oxygen uptake efficiency slope (OUES)

Determined as the linear relationship between oxygen uptake and the logarithmic transformation of minute ventilation during the cardiopulmonary exercise test

Concentration of cholesterol (mmol/L)

Concentrations of total cholesterol, low-density lipoprotein (LDL-C) and high-density lipoprotein (HDL-C) were measured from venous blood.

Concentration of triglycerides (mmol/L)

The concentration of triglycerides was measured from venous blood.

Concentration of testosterone (nmol/L)

Concentration of total testosterone was measured from venous blood.

Concentration of sex hormone binding globulin (nmol/L)

Concentration of sex hormone binding globulin was measured from venous blood.

QRISK®2-2017 score

The percent risk of a cardiovascular disease event occurring in the next 10 years was calculated with QRISK®2-2017 Web Calculator (https://qrisk.org/2017). The total score ranges from 0 to 100 %, with higher scores indicating a greater risk of cardiovascular disease.

Gleason score

Gleason scores were measured from prostate biopsies. A score of 1 to 5 is assigned to the cells that make up the largest area of the tumor and another score of 1 to 5 is assigned to the cells that comprise the next largest area. A total Gleason score is then calculated by adding both of these scores together. Total scores ranged from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.

Prostate specific antigen (ng/mL)

Concentration of prostate specific antigen was measured from venous blood.

Skinfold thickness (mm)

Skinfold thickness was measured at suprailiac and subscapular sites with a skinfold caliper (Harpenden Skinfold Caliper, Baty International, Sussex, UK).

Hand grip strength (kg)

Hand grip strength was measured with an analogue dynamometer (Takei Scientific Instruments Ltd., Tokyo, Japan).

The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire (version 4)

Disease-specific health-related quality of life was assessed with the FACT-P 39-item questionnaire (version 4). Each item has a 5-point Likert-like response scale ranging from 0 ("Not at all") to 4 ("Very much"). A total score is calculated as the sum of each score from items 1 to 39, which can range from 0 to 156. Negatively worded items are reverse scored (subtracted from 4) prior to summing so that higher total scores indicate better health-related quality of life.

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale (version 4)

Fatigue was assessed with the 13-item FACIT-Fatigue scale (version 4). Each item has a 5-point Likert-like response scale ranging from 0 ("Not at all") to 4 ("Very much"). A total score is calculated as the sum of each score from items 1 to 13, which can range from 0 to 52. Negatively worded items are reverse scored (subtracted from 4) prior to summing so that higher total scores indicate less experience of fatigue.

Godin Leisure-Time Exercise questionnaire

The Godin Leisure-Time Exercise questionnaire was used to characterise levels of physical activity. The questionnaire contains three items and asks the patient to recall the number of bouts of strenuous, moderate, or mild physical activity that exceed 15 min in duration in which they have engaged in over a typical week. A total score is calculated by multiplying the number of strenuous, moderate, and mild physical activity bouts by weights of 9, 5, and 3, respectively, and summing those values in an overall score that ranges from 0 to 119 in arbitrary units. Higher scores indicate participation in higher levels of physical activity.

Number of recruited participants

Measured as the number of eligible participants who were eligible and consented to participate in the trial. This will be reported in a Consolidated Standards of Reporting Trials (CONSORT) participant flowchart.

Number of adverse events

The number of adverse events were recorded to determine the feasibility of the exercise intervention. An adverse event was defined as the occurrence of any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the exercise intervention. The type of adverse events was also noted.

Attrition rate

Established as the number of patients in the experimental group who discontinued the exercise intervention

Number of patients who were lost to follow-up

In the experimental group, patients lost to follow-up were characterised as those who completed the exercise intervention but did not complete endpoint testing. In the control group, patients lost to follow-up were the number of patients who did not complete endpoint testing.

Average number of exercise sessions completed

The number of exercise sessions completed by each participant in the intervention group was recorded. These values were than averaged to provide a measure of adherence. The maximum number of exercise sessions that participants could complete was 24, so adherence ranged from 0 to 24 sessions, with higher scores indicating greater adherence.

Full Information

NCT ID

NCT03776045

First Posted

December 6, 2018

Last Updated

December 12, 2018

Sponsor

University of East Anglia

Collaborators

Norfolk and Norwich University Hospitals NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03776045

Brief Title

PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)

Acronym

PROSCARDIO

Official Title

Effects of Exercise in Prostate Cancer Patients Initiating Androgen Deprivation Therapy: A Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

August 12, 2013 (Actual)

Primary Completion Date

February 3, 2016 (Actual)

Study Completion Date

February 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of East Anglia

Collaborators

Norfolk and Norwich University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study evaluates whether exercise can reduce treatment-related adverse effects in prostate cancer patients initiating androgen deprivation therapy. Half of recruited participants completed a 3-month exercise intervention, while the other half did not perform any supervised exercise. It was anticipated that exercise would have a positive effect on body composition, cardiorespiratory fitness and quality of life.

Detailed Description

Androgen deprivation therapy (ADT) is routinely used as first-line treatment for locally advanced and metastatic prostate cancer. However, it is associated with many side effects such as increased fat mass and reduced skeletal muscle mass, cardiorespiratory fitness and metabolic health. Ultimately, these negative changes induced by ADT contribute to reduced health-related quality of life (HRQoL). This study evaluates whether 3-months of exercise can mitigate treatment toxicity in prostate cancer patients initiating ADT. In a parallel groups, prospective, randomised controlled design, participants were randomly allocated to a standard care control group or standard care plus exercise group. The exercise group completed 3-months of combined aerobic and resistance training. The standard care group did not receive any supervised exercise or specific physical activity recommendations. Outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up) endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate Cancer, Androgen deprivation therapy, Exercise

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

After baseline measures were collected, participants were randomly allocated (1:1) to standard care or standard care plus exercise using a randomisation sequence created by an independent researcher (nQuery, Statistical Solutions, USA). Treatment allocation was concealed from the research team until after baseline measurements were collected.

Masking

Outcomes Assessor

Masking Description

Outcome assessors and data analysts were blind to treatment allocation. It was not possible to blind participants or the intervention facilitator.

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

Arm Title

Standard care plus exercise

Arm Type

Experimental

Arm Description

This group received standard care in addition to a 3-month exercise intervention upon initiating androgen deprivation therapy.

Intervention Type

Other

Intervention Name(s)

Standard care plus exercise

Intervention Description

The exercise was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK. Participants competed two weekly sessions for 12 weeks upon initiating ADT. Each session lasted ~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. In addition to the supervised exercise sessions, patients were advised on how to increase their habitual physical activity levels and were encouraged to engage in 30 minutes of self-directed exercise on three days each week (e.g. brisk walking, cycling, home-based resistance training).

Primary Outcome Measure Information:

Title

Whole body fat mass (kg)

Description

Time Frame

Adjusted mean difference between groups at 3-month endpoint

Secondary Outcome Measure Information:

Title

Whole body fat mass (kg)

Description

Time Frame

Adjusted mean difference between groups at 6-month endpoint

Title

Whole body fat-free mass (kg)

Description

Time Frame