Prostate CancerNCT02135653
A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
An observational study of Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Radiotherapy and Eischens Yoga
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with stage I or II prostate cancer undergoing radiation therapy. Enrolled subjects will not have smoked nor taken any regular yoga classes in the 6 months preceding their participation in the study. Additionally they will have not undergone a surgical prostatectomy
Who may be able to join
- Patients
- Prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). Prior or concurrent androgen deprivation therapy is permitted.
- Patients of age >18 years, and all races will be included in the study.
- Patients must have an ECOG Performance Score ≤ 1
- All patients must sign an informed consent form
- Caregivers
Show all 9Show fewer
- Subject is age >18 years
- Subject is English-speaking
- Subject must sign an informed consent form
Who cannot join
- Patients
- Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ECOG Performance Status score.
- Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
- Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
- Patients who are undergoing chemotherapy for any reason
- Patients with evidence of metastatic disease
Show all 11Show fewer
- Caregivers
- Subjects that are unwilling or unable to provide informed consent
- Subjects with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions
- Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
- Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.
Read the detailed description
The feasibility study refers to the ability to recruit patients willing to participate in the Eischens yoga interventional arm. Those who are recruited during the feasibility study are seemlessly move to the Phase II study, and for this reason the feasibility study and Eischens yoga interventional arms are reported simply as the Eischens yoga interventional arm.
- Conditions
- Prostate Cancer
- Being tested
- Radiotherapy, Eischens Yoga
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Eischens YogaOther
| Study group | Role | What they receive |
|---|---|---|
| Feasibility Phase: Eischens Yoga Group | Not described Receives: Radiation: Radiotherapy; Other: Eischens Yoga | |
| Phase II: Eischens Yoga Group | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: 8 weeks
Secondary outcomes (7)
Brief Fatigue Inventory Score
A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue
Measured: 8 weeks
Functional Assessment of Cancer Therapy: Physical Well-Being Score
7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being
Measured: 8 weeks
Functional Assessment of Cancer Therapy: Social Well-Being Score
7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being
Measured: 8 weeks
Functional Assessment of Cancer Therapy: Emotional Well-Being Score
6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being
Measured: 8 weeks
Functional Assessment of Cancer Therapy: Functional Well-Being
7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being
Measured: 8 weeks
International Index of Erectile Function Score
5 item and 5 point Likert-scale The scores range from 0 to 25, with scores >21 indicating normal erectile function and scores <12 indicating moderate to severe ED
Measured: 8 weeks
International Prostate Symptom Score
8 item 6 point Likert-scale Scores on this scale range from 0 to 35, with a score of 8 to 19 indicating moderate urinary symptoms and 20 to 35 severe urinary symptoms
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startMar 2013
- Primary completion24 May 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neha Vapiwala, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135653
- Sponsor's protocol ID
- UPCC 05813
- Status last verified
- Apr 2021
- First submitted
- 2 May 2014
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
- ClinicalTrials.gov ID
- NCT02135653
- Acronym / sponsor ID
- UPCC 05813
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- 24 May 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Posted 19 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.
Detailed description
The feasibility study refers to the ability to recruit patients willing to participate in the Eischens yoga interventional arm. Those who are recruited during the feasibility study are seemlessly move to the Phase II study, and for this reason the feasibility study and Eischens yoga interventional arms are reported simply as the Eischens yoga interventional arm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feasibility Phase: Eischens Yoga Group | – | Radiation: Radiotherapy, Other: Eischens Yoga |
| Phase II: Eischens Yoga Group | – | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with stage I or II prostate cancer undergoing radiation therapy. Enrolled subjects will not have smoked nor taken any regular yoga classes in the 6 months preceding their participation in the study. Additionally they will have not undergone a surgical prostatectomy
Key inclusion criteria (9 listed)
- Patients
- Prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). Prior or concurrent androgen deprivation therapy is permitted.
- Patients of age >18 years, and all races will be included in the study.
- Patients must have an ECOG Performance Score ≤ 1
- All patients must sign an informed consent form
Key exclusion criteria (11 listed)
- Patients
- Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ECOG Performance Status score.
- Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
- Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
- Patients who are undergoing chemotherapy for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy | Radiation | Feasibility Phase: Eischens Yoga Group, Phase II: Eischens Yoga Group |
| Eischens Yoga | Other | Feasibility Phase: Eischens Yoga Group |
Primary outcome
Adverse Events
Time frame: 8 weeks
7 secondary outcomes
Brief Fatigue Inventory Score
Time frame: 8 weeks
Functional Assessment of Cancer Therapy: Physical Well-Being Score
Time frame: 8 weeks
Functional Assessment of Cancer Therapy: Social Well-Being Score
Time frame: 8 weeks
Functional Assessment of Cancer Therapy: Emotional Well-Being Score
Time frame: 8 weeks
Functional Assessment of Cancer Therapy: Functional Well-Being
Time frame: 8 weeks
International Index of Erectile Function Score
Time frame: 8 weeks
International Prostate Symptom Score
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Vapiwala, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site 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 11 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: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 19 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2021.