ClinicalTrials.gg
CompletedNCT03461471EnACTUpdated Jun 25, 2019

Exercise in All ChemoTherapy

An interventional study of Exercise Intervention in Chemotherapy and Exercise, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-25.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2017, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Motor Activity by Milton S. Hershey Medical Center — none open to participants now, none under way, none of them phase 3. Motor Activity · Milton S. Hershey Medical Center.

Enrollment
4th of 21
168 · median 32
Started
2017
with 4 others
No phase
19 of 22
none open now
Registered
7th of 22
by date

Among the 22 studies in Motor Activity by Milton S. Hershey Medical Center, this one is the 4th largest by enrollment of the 21 interventional ones that give a count, is one of 5 that started in 2017, is one of 19 with no phase, and was the 7th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

None of the 22 studies in Motor Activity by Milton S. Hershey Medical Center is open now.

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Download CSVNarrow it in search →With an account: the 22 studies in Motor Activity by Milton S. Hershey Medical Center as a file.
02

Study summary

Exercise in all Chemotherapy (EnACT) is a study to assess safety, feasibility, and acceptability of an exercise program within chemotherapy. This will be a single group study to capture the effects of an exercise intervention on the average chemotherapy patient and the patients compliance to the study.

Read the detailed description

Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that exercise training is safe during primary adjuvant therapy and improves physical function and quality of life outcomes. Moderate exercise has been shown to improve fatigue (extreme tiredness), anxiety, and self-esteem. It also helps heart and blood vessel fitness, muscle strength, and body composition. However, despite guidance on implementing exercise recommendations for cancer patients, exercise counseling is still not standard of care in cancer centers across the U.S. Our goal is to collect data that will assist with translation of the evidence from randomized clinical trials into standard of care.

03

Conditions studied

  • Chemotherapy
  • Exercise

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males and females ≥18 years of age
  • Fluent in written and spoken English
  • Must be able to provide and understand
  • Must have an PS of ≤ 2
  • Diagnosed with a solid tumor
  • Cancer patients (stage 1-4)
  • Scheduled to receive chemotherapy at Penn State Cancer Institute
  • Absence of absolute for exercise according to the American Heart Association
  • Primary attending oncologist approval

Exclusion criteria

Exclusion Criteria:

  • Receiving chemotherapy at a location other than Penn State Cancer Institute
  • Not fluent in written and spoken English
  • Hematological
  • Evidence in the medical record of an absolute for exercise
  • Cardiac exclusion criteria:

    • Class II, III or IV heart failure as defined by the (NYHA) functional classification system
    • History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of chemotherapy
    • Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for >1 month prior to start of chemotherapy may be eligible
    • syncope
    • acute myocarditis, pericarditis, or endocarditis
    • acute pulmonary embolus or pulmonary infarction
    • thrombosis of lower extremities
    • suspected dissecting aneurysm
    • pulmonary edema
    • respiratory failure
    • acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
    • mental impairment leading to inability to cooperate
  • Non-English speaking
  • Pregnant women
  • Children (the protocol will only include individuals 18 and older)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
168 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Exercise intervention

    Behavioral: Exercise Intervention

Interventions

  • BehavioralExercise Intervention

    Exercise intervention

06

What researchers measure

Primary outcomes

  1. Assess Feasibility

    Feasibility will be obtained if one third of chemotherapy patients actually do the exercise prescribed (one exercise session per week for four weeks).

    Time frame: Feasibility will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).

Secondary outcomes

  1. Compare changes in pain, physical function, nausea, vomiting, arthralgias, chemotherapy alterations (dose delays and alterations).

    This will be compared using surveys at the beginning and end of chemotherapy (or intervention). Data will also be collected on the initial chemotherapy prescription and whether there are dose alterations.

    Time frame: Surveys will be given once the patient is consented and again at the completion of the study for each patient (average of 5 months per patient).

  2. Qualitative assessments of clinician perspectives regarding the study. At the end of the study clinicians will be asked a series of qualitative questions to gain their insight into the study.

    At the conclusion of the study, clinicians within the institution will be asked qualitative questions regarding the study.

    Time frame: Surveys will be provided to clinicians at the completion of the study (up to 38 months)

  3. Assessing safety through number of patients with injuries related to the intervention

    The investigator will be using a standardized Adverse Events/Injury History survey as the primary instrument in assessing safety. This survey focuses on asking questions to gauge the participants experience with muscle strain, joint pain, among other things, in order to assess if there were any complications associated with the intervention. The investigator will consider the intervention safe if less than 25% of included patients report mild musculoskeletal impairments and less than 5% experienced musculoskeletal injuries (defined as symptoms lasting a week or longer and or requiring the attention of a medical professional).

    Time frame: A standardized survey for assessing injuries will be used and administered at the end of the patients chemotherapy (average of 5 months)..

  4. Assess Acceptability

    We will consider the intervention to be acceptable if more than 50% of the patients approached agree to receive at least the first session of exercise counseling.

    Time frame: Acceptability will be assessed at the completion of the study for each patient (average of 5 months of chemotherapy).

07

Study locations

1 site
  • Penn State Cancer Institute
    Hershey, Pennsylvania 17033, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2017 to primary completion in Mar 2019, 23 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 23 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 25, 2017
First posted
Mar 12, 2018
StartActual
Apr 1, 2017
Primary completionActual
Mar 30, 2019
CompletionActual
Mar 30, 2019
Last update
Jun 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03461471
Responsible party
Kathryn Schmitz (Professor, Public Health Science, Milton S. Hershey Medical Center) — Principal investigator
First posted
Mar 12, 2018
Start date
Apr 1, 2017
Primary completion
Mar 30, 2019
Completion
Mar 30, 2019
Last update
Jun 25, 2019

Study contacts

Kathryn Schmitz, PhD
principal investigator · Penn State College of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion