LymphedemaWISER SurvivorNCT01515124
The Women In Steady Exercise Research (WISER) Survivor Trial
A study testing Exercise Intervention and Weight Loss Intervention in people with Lymphedema, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. Read more about this study
- Who is it for?
- Ages Up to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema
- What is being tested?
- Exercise Intervention and Weight Loss Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- breast cancer survivor
- overweight or obese (BMI of 25 or greater)
- must have breast cancer related lymphedema
- at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
- the eligible age range will have no lower limit.
- currently free of cancer
Who cannot join
- medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
- inability to walk for 6 minutes unaided
- extremely obese (body mass index greater or equal to 50 kg/m2)
- plans for additional (e.g. curative or reconstructive) surgery during the study period
- self-report of weight-lifting within the past year
- already engaging in 3 or more times weekly aerobic activity of moderate intensity
Show all 12Show fewer
- planning to move away from the area over the next year
- current use of weight loss medication (OTC or prescription)
- self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week)
- weight loss of greater than 10 % in the past 3 months
- history of bariatric surgery
- women who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
The Penn TREC Survivorship Center
Hershey, Pennsylvania, 17033
About this study
Official title: The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.
- Conditions
- Lymphedema
- Being tested
- Exercise Intervention, Weight Loss Intervention
- Keywords
- Lymphedema, Strength training intervention, Weight loss intervention, Breast cancer recurrence, Cost Effectiveness
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.
Weight Loss InterventionBehavioural
The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.
| Study group | Role | What they receive |
|---|---|---|
| Lymphedema Care Only | No intervention | All 4 groups receive lymphedema care as follows: 1. 2 custom fitted compression garments (baseline and 6 months) 2. evaluations for flare-ups at request (and at each measurement time point) 3. lymphedema treatment by a certified lymphatic therapist upon detection of a flare-up, paid for by the study. No limit was placed on number of sessions. |
| Exercise only | Experimental | The Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions. Exercise only group members also received the Lymphedema care intervention described above. Receives: Behavioral: Exercise Intervention |
| Weight loss only | Experimental | The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact. Weight loss only group members also received the Lymphedema care intervention described above. Receives: Behavioral: Weight Loss Intervention |
| Exercise and Weight loss combined | Experimental | Participants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above. Receives: Behavioral: Exercise Intervention; Behavioral: Weight Loss Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent interlimb difference, change over 12 months.
Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome
Measured: Baseline and 12 months
Secondary outcomes (18)
Clinical Lymphedema Events
Flare-ups and cellulitic infections (number and type recorded)
Measured: Data collected over the 12 month follow-up, with events collected as reported
Clinical Evaluation Score for Lymphedema
Standardized clinical evaluation survey completed by certified lymphatic therapists
Measured: Baseline and 12 months
Norman Lymphedema Survey
Thirteen symptoms, recorded within a standardized survey (Norman Lymphedema Survey)
Measured: Baseline and 12 months
Weight loss
body weight loss over 12 months
Measured: Baseline and 12 months
Biomarkers: Estradiol
circulating estradiol levels in the blood
Measured: baseline and 12 months
Biomarkers: Testosterone
circulating testosterone levels in the blood
Measured: baseline and 12 months
Biomarkers - Sex Hormone Binding Globulin
circulating sex hormone binding globulin levels in the blood
Measured: baseline and 12 months
Inflammation: Interleukin six
Circulating interleukin six levels in the blood
Measured: baseline and 12 months
Inflammation: C reactive protein
Circulating c reactive protein levels in the blood
Measured: baseline and 12 months
Adiponectin
circulating Adiponectin levels in the blood
Measured: baseline and 12 months
Leptin
circulating leptin levels in the blood
Measured: baseline and 12 months
F2-isoprostanes
circulating F2-isoprostane levels in the blood
Measured: baseline and 12 months
Insulin
circulating insulin levels in the blood
Measured: baseline and 12 months
Glucose
circulating glucose levels in the blood
Measured: baseline and 12 months
insulin like growth factor one
circulating levels of insulin like growth factor one in the blood
Measured: baseline and 12 months
insulin like growth factor binding protein three
circulating levels of insulin like growth factor binding protein three in the blood
Measured: baseline and 12 months
Upper limb lymphedema twenty seven
27 item survey on lymphedema quality of life
Measured: baseline and 12 months
body image and relationship survey
32 item survey on body image specifically developed for breast cancer survivors
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (113)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn H. Schmitz, MPH,PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515124
- Sponsor's protocol ID
- U54CA155850
- Acronym
- WISER Survivor
- Status last verified
- Oct 2022
- First submitted
- 18 Jan 2012
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.
PubMed 20052559Hewitt M, Greenfield, S., Stovall, E. , ed. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, D.C.: National Academies Press; 2006.
Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol. 2009 Jun 10;27(17):2758-65. doi: 10.1200/JCO.2008.20.8983. Epub 2009 Apr 29.
PubMed 19403886Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
PubMed 19474385Hursting SD, Lashinger LM, Colbert LH, Rogers CJ, Wheatley KW, Nunez NP, Mahabir S, Barrett JC, Forman MR, Perkins SN. Energy balance and carcinogenesis: underlying pathways and targets for intervention. Curr Cancer Drug Targets. 2007 Aug;7(5):484-91. doi: 10.2174/156800907781386623.
PubMed 17691908Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.
PubMed 15914748Friedenreich CM, Gregory J, Kopciuk KA, Mackey JR, Courneya KS. Prospective cohort study of lifetime physical activity and breast cancer survival. Int J Cancer. 2009 Apr 15;124(8):1954-62. doi: 10.1002/ijc.24155.
PubMed 19123472Irwin ML, Smith AW, McTiernan A, Ballard-Barbash R, Cronin K, Gilliland FD, Baumgartner RN, Baumgartner KB, Bernstein L. Influence of pre- and postdiagnosis physical activity on mortality in breast cancer survivors: the health, eating, activity, and lifestyle study. J Clin Oncol. 2008 Aug 20;26(24):3958-64. doi: 10.1200/JCO.2007.15.9822.
PubMed 18711185Armer JM. The problem of post-breast cancer lymphedema: impact and measurement issues. Cancer Invest. 2005;23(1):76-83.
PubMed 15779870Norman SA, Localio AR, Potashnik SL, Simoes Torpey HA, Kallan MJ, Weber AL, Miller LT, Demichele A, Solin LJ. Lymphedema in breast cancer survivors: incidence, degree, time course, treatment, and symptoms. J Clin Oncol. 2009 Jan 20;27(3):390-7. doi: 10.1200/JCO.2008.17.9291. Epub 2008 Dec 8.
PubMed 19064976Francis WP, Abghari P, Du W, Rymal C, Suna M, Kosir MA. Improving surgical outcomes: standardizing the reporting of incidence and severity of acute lymphedema after sentinel lymph node biopsy and axillary lymph node dissection. Am J Surg. 2006 Nov;192(5):636-9. doi: 10.1016/j.amjsurg.2006.08.018. No abstract available.
PubMed 17071198Schrenk P, Rieger R, Shamiyeh A, Wayand W. Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma. Cancer. 2000 Feb 1;88(3):608-14. doi: 10.1002/(sici)1097-0142(20000201)88:33.0.co;2-k.
PubMed 10649254Wilke LG, McCall LM, Posther KE, Whitworth PW, Reintgen DS, Leitch AM, Gabram SG, Lucci A, Cox CE, Hunt KK, Herndon JE 2nd, Giuliano AE. Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol. 2006 Apr;13(4):491-500. doi: 10.1245/ASO.2006.05.013. Epub 2006 Mar 2.
PubMed 16514477Petrek JA, Heelan MC. Incidence of breast carcinoma-related lymphedema. Cancer. 1998 Dec 15;83(12 Suppl American):2776-81. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.0.co;2-v.
PubMed 9874397Shih YC, Xu Y, Cormier JN, Giordano S, Ridner SH, Buchholz TA, Perkins GH, Elting LS. Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol. 2009 Apr 20;27(12):2007-14. doi: 10.1200/JCO.2008.18.3517. Epub 2009 Mar 16.
PubMed 19289624
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Women In Steady Exercise Research (WISER) Survivor Trial & Cost of Illness and Cost Effectiveness of Alternative Management Strategies
- ClinicalTrials.gov ID
- NCT01515124
- Acronym / sponsor ID
- WISER Survivor / U54CA155850
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Strength training intervention, Weight loss intervention, Breast cancer recurrence, Cost Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
WISER Survivor is a one year weight loss and exercise study for sedentary breast cancer survivors who are overweight or obese with breast cancer related lymphedema. There will be four groups in this trial: exercise only, weight loss only, exercise and weight-loss combined, and a control group. The primary purpose of this study is to test the effects of these interventions on clinical lymphedema outcomes. Secondary outcomes include weight loss, breast cancer related biomarkers, and quality of life. To the extent that funding will be available, participants will be followed long term to examine effects on recurrence and mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lymphedema Care Only | No intervention | –All 4 groups receive lymphedema care as follows: 1. 2 custom fitted compression garments (baseline and 6 months) 2. evaluations for flare-ups at request (and at each measurement time point) 3. lymphedema treatment by a certified lymphatic therapist upon detection of a flare-up, paid for by the study. No limit was placed on number of sessions. |
| Exercise only | Experimental | Behavioral: Exercise InterventionThe Exercise Intervention combines 60-90 minute twice-weekly supervised weight-lifting sessions with 180 minutes of weekly aerobic exercise. Women will be trained by certified fitness professionals in both the weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. All exercise participants will be provided with 'Power Blocks' which are adjustable dumbbells with which they can increase resistance in 1-2 pound increments from 1-21 pounds. All weight training will be done in their homes except for the first 6 weekly session and monthly check-in sessions. Exercise only group members also received the Lymphedema care intervention described above. |
| Weight loss only | Experimental | Behavioral: Weight Loss InterventionThe Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem®, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. Participants will be guided to stay at the same number of calories per day until reaching goal weight, followed by a gradual increase in caloric intake (of approximately 500 calories/d) to maintain their weight throughout the remainder of the intervention. The treatment groups will be led by registered dietitians and will receive ongoing supervision via telephone and email contact. Weight loss only group members also received the Lymphedema care intervention described above. |
| Exercise and Weight loss combined | Experimental | Behavioral: Exercise Intervention, Behavioral: Weight Loss InterventionParticipants in this group will receive a combination of the supervised twice-weekly weight training sessions and the weight loss program. Combined group members also received the Lymphedema care intervention described above. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- breast cancer survivor
- overweight or obese (BMI of 25 or greater)
- must have breast cancer related lymphedema
- at least 6 months post-treatment (e.g. surgery, chemotherapy, or radiotherapy) but there will be no upper limit on time elapsed from diagnosis
- the eligible age range will have no lower limit.
Key exclusion criteria (12 listed)
- medical conditions or medications that would prohibit participation in an exercise program or would negatively impact our ability to test our primary aims
- inability to walk for 6 minutes unaided
- extremely obese (body mass index greater or equal to 50 kg/m2)
- plans for additional (e.g. curative or reconstructive) surgery during the study period
- self-report of weight-lifting within the past year
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 |
|---|---|---|
| Exercise InterventionThe Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions. | Behavioural | Exercise and Weight loss combined, Exercise only |
| Weight Loss InterventionThe Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day. | Behavioural | Exercise and Weight loss combined, Weight loss only |
Primary outcome
Percent interlimb difference, change over 12 months.
Time frame: Baseline and 12 months
Arm volumes for affected and unaffected limbs will be measured by perometry and the % difference will be determined at baseline and 12 months. the absolute percentage point difference of differences (% interlimb difference at 12 months minus % interlimb difference at baseline) will be the primary outcome
18 secondary outcomes
Clinical Lymphedema Events
Time frame: Data collected over the 12 month follow-up, with events collected as reported
Clinical Evaluation Score for Lymphedema
Time frame: Baseline and 12 months
Norman Lymphedema Survey
Time frame: Baseline and 12 months
Weight loss
Time frame: Baseline and 12 months
Biomarkers: Estradiol
Time frame: baseline and 12 months
Biomarkers: Testosterone
Time frame: baseline and 12 months
Biomarkers - Sex Hormone Binding Globulin
Time frame: baseline and 12 months
Inflammation: Interleukin six
Time frame: baseline and 12 months
Inflammation: C reactive protein
Time frame: baseline and 12 months
Adiponectin
Time frame: baseline and 12 months
Leptin
Time frame: baseline and 12 months
F2-isoprostanes
Time frame: baseline and 12 months
Insulin
Time frame: baseline and 12 months
Glucose
Time frame: baseline and 12 months
insulin like growth factor one
Time frame: baseline and 12 months
insulin like growth factor binding protein three
Time frame: baseline and 12 months
Upper limb lymphedema twenty seven
Time frame: baseline and 12 months
body image and relationship survey
Time frame: baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 20052559Speck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6.
- BackgroundHewitt M, Greenfield, S., Stovall, E. , ed. From Cancer Patient to Cancer Survivor: Lost in Transition. Washington, D.C.: National Academies Press; 2006.
- Background: PubMed 19403886Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of cancer incidence in the United States: burdens upon an aging, changing nation. J Clin Oncol. 2009 Jun 10;27(17):2758-65. doi: 10.1200/JCO.2008.20.8983. Epub 2009 Apr 29.
- Background: PubMed 19474385Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
- Background: PubMed 17691908Hursting SD, Lashinger LM, Colbert LH, Rogers CJ, Wheatley KW, Nunez NP, Mahabir S, Barrett JC, Forman MR, Perkins SN. Energy balance and carcinogenesis: underlying pathways and targets for intervention. Curr Cancer Drug Targets. 2007 Aug;7(5):484-91. doi: 10.2174/156800907781386623.
- Background: PubMed 15914748Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479.
- Background: PubMed 19123472Friedenreich CM, Gregory J, Kopciuk KA, Mackey JR, Courneya KS. Prospective cohort study of lifetime physical activity and breast cancer survival. Int J Cancer. 2009 Apr 15;124(8):1954-62. doi: 10.1002/ijc.24155.
- Background: PubMed 18711185Irwin ML, Smith AW, McTiernan A, Ballard-Barbash R, Cronin K, Gilliland FD, Baumgartner RN, Baumgartner KB, Bernstein L. Influence of pre- and postdiagnosis physical activity on mortality in breast cancer survivors: the health, eating, activity, and lifestyle study. J Clin Oncol. 2008 Aug 20;26(24):3958-64. doi: 10.1200/JCO.2007.15.9822.
- Background: PubMed 15779870Armer JM. The problem of post-breast cancer lymphedema: impact and measurement issues. Cancer Invest. 2005;23(1):76-83.
- Background: PubMed 19064976Norman SA, Localio AR, Potashnik SL, Simoes Torpey HA, Kallan MJ, Weber AL, Miller LT, Demichele A, Solin LJ. Lymphedema in breast cancer survivors: incidence, degree, time course, treatment, and symptoms. J Clin Oncol. 2009 Jan 20;27(3):390-7. doi: 10.1200/JCO.2008.17.9291. Epub 2008 Dec 8.
- Background: PubMed 17071198Francis WP, Abghari P, Du W, Rymal C, Suna M, Kosir MA. Improving surgical outcomes: standardizing the reporting of incidence and severity of acute lymphedema after sentinel lymph node biopsy and axillary lymph node dissection. Am J Surg. 2006 Nov;192(5):636-9. doi: 10.1016/j.amjsurg.2006.08.018. No abstract available.
- Background: PubMed 10649254Schrenk P, Rieger R, Shamiyeh A, Wayand W. Morbidity following sentinel lymph node biopsy versus axillary lymph node dissection for patients with breast carcinoma. Cancer. 2000 Feb 1;88(3):608-14. doi: 10.1002/(sici)1097-0142(20000201)88:33.0.co;2-k.
- Individual participant dataSharing planned: No
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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.
Kathryn H. Schmitz, MPH,PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention and Weight Loss Intervention in people with Lymphedema, run by Milton S. Hershey Medical Center 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 6 inclusion and 12 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 10 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent interlimb difference, change over 12 months. (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01515124, which also lists 113 linked publications.
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 10 Oct 2022.