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LymphedemaPhase 1/2NCT02650297

The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema

A Phase 1/2 study testing combined decongestive therapy and pneumatic compression pump in people with Lymphedema, run by badri jaafari.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer related lymphedema participated. Read more about this study

Who is it for?
Ages 35 to 70 years, women only
Conditions the study is for
Lymphedema
What is being tested?
combined decongestive therapy and pneumatic compression pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
Oct 2009to Dec 2009
Phase
Phase 1/2
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 35 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histoty of breast cancer,
  • history of surgery and chemotherapy and as needed hormone therapy and radiotherapy,
  • affected by lymphedema (with degree of mild to severe) based on specialist diagnosis,
  • at least 1 year ago was undergone axillary node dissection,
  • do not have knowledge about combined decongestive therapy,
  • phone accessibility,
  • 35-70 years old.

Who cannot join

  • psychotic disorder,
  • existence sever pain at axillary area,
  • history of hysterectomy duo to uterus cancer,
  • severe cardiac disease,
  • heart failure,
  • renal failure,
Show all 10Show fewer
  • severe hypertension,
  • existing other malignancies,
  • recurrent infection in arm,
  • musclo skeletal disease

About this study

Official title: The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema Secondary to Breast Cancer Treatment

Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, Combined DecongestiveTherapy was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.

Read the detailed description

Background:

Lymphedema is a common complication for breast cancer therapy. Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.

methods: 42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). A certified nurse worked on Combined Decongestive Therapy in the intervention group in two phases. In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, CDT was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.

Conditions
Lymphedema
Being tested
combined decongestive therapy, pneumatic compression pump
Keywords
Lymphedema secondary to breast cancer, Breast cancer, Body image
Medical subject headings
Lymphedema, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • combined decongestive therapyOther

    Patients in the intervention group received treatment with combined decongestive therapy and pneumatic compression pump. Patients in the control group received no treatment for lymphedema but were placed on the waiting list for combined decongestive therapy and pneumatic compression pump as soon as possible after the 8 weeks follow-up period.

  • pneumatic compression pumpDevice

    Intermittent pneumatic pump or pressure therapy is not as a part of CDT, but it can be used as an adjunct method. This device intermittently and according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk

Study groups in NCT02650297
Study groupRoleWhat they receive
CDT and pneumatic compression pumpExperimentalcombined decongestive therapy consists of the pressure of bandage, manual lymphatic drainage, and exercises that increase the flow of lymph and skin care are used. Intermittent pneumatic pump is not as a part of CDT, but it can be used as an adjunct method. This device according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk.
Receives: Other: combined decongestive therapy; Device: pneumatic compression pump
not CDT and pneumatic compression pumpNo interventionPatients in the control group received no treatment for lymphedema but were placed on the waiting list for CDT as soon as possible after the 8 weeks follow-up period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in the body image

    Body image evaluated with the body image and relationships scale. Body image and relationships scale is a questionnaire that consists of 32 items in the three subscales or factors, named strength and health, social barriers, and appearance and sexuality. Higher scores on each subscale indicated greater impairment.

    Measured: change from baseline body image at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2016 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2009
  4. Study completionDec 2009

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650297
Sponsor's protocol ID
IAUKazeroun
Status last verified
Jan 2016
First submitted
29 Dec 2015
Last updated
8 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Isaksson G, Feuk B. Morbidity from axillary treatment in breast cancer--a follow-up study in a district hospital. Acta Oncol. 2000;39(3):335-6. doi: 10.1080/028418600750013104. No abstract available.

    PubMed 10987230

  • Kaviani A, Lotfi M. Control of lymphedema after breast cancer treatment. 1st ed. Tehran: Tehran university of medical

  • Didem K, Ufuk YS, Serdar S, Zumre A. The comparison of two different physiotherapy methods in treatment of lymphedema after breast surgery. Breast Cancer Res Treat. 2005 Sep;93(1):49-54. doi: 10.1007/s10549-005-3781-2.

    PubMed 16184458

  • Nielsen I, Gordon S, Selby A. Breast cancer-related lymphoedema risk reduction advice: a challenge for health professionals. Cancer Treat Rev. 2008 Nov;34(7):621-8. doi: 10.1016/j.ctrv.2007.11.002. Epub 2008 Aug 8.

    PubMed 18691823

  • Hormes JM, Lytle LA, Gross CR, Ahmed RL, Troxel AB, Schmitz KH. The body image and relationships scale: development and validation of a measure of body image in female breast cancer survivors. J Clin Oncol. 2008 Mar 10;26(8):1269-74. doi: 10.1200/JCO.2007.14.2661.

    PubMed 18323550

  • Ridner SH. The psycho-social impact of lymphedema. Lymphat Res Biol. 2009;7(2):109-12. doi: 10.1089/lrb.2009.0004.

    PubMed 19534633

  • Pain SJ, Purushotham AD. Lymphoedema following surgery for breast cancer. Br J Surg. 2000 Sep;87(9):1128-41. doi: 10.1046/j.1365-2168.2000.01569.x.

    PubMed 10971418

  • Foldi M. Lymphology in the second millennium. Lymphology. 2001 Mar;34(1):12-21. No abstract available.

    PubMed 11307660

  • Harris SR, Hugi MR, Olivotto IA, Levine M; Steering Committee for Clinical Practice Guidelines for the Care and Treatment of Breast Cancer. Clinical practice guidelines for the care and treatment of breast cancer: 11. Lymphedema. CMAJ. 2001 Jan 23;164(2):191-9.

    PubMed 11332311

  • Uzkeser H, Karatay S, Erdemci B, Koc M, Senel K. Efficacy of manual lymphatic drainage and intermittent pneumatic compression pump use in the treatment of lymphedema after mastectomy: a randomized controlled trial. Breast Cancer. 2015 May;22(3):300-7. doi: 10.1007/s12282-013-0481-3. Epub 2013 Aug 8.

    PubMed 23925581

  • Irdesel J, Celiktas SK. Effectiveness of exercise and compression garments in the treatment of breast cancer related lymphedema- Original article. Turk J Phys Med Rehab, 2007;53:16-21.

  • Passik S, Newman M, Brennan M, Holland J. Psychiatric consultation for women undergoing rehabilitation for upper-extremity lymphedema following breast cancer treatment. J Pain Symptom Manage. 1993 May;8(4):226-33. doi: 10.1016/0885-3924(93)90132-f.

    PubMed 7963764

  • Pruzinsky T. Enhancing quality of life in medical populations: a vision for body image assessment and rehabilitation as standards of care. Body Image. 2004 Jan;1(1):71-81. doi: 10.1016/S1740-1445(03)00010-X.

    PubMed 18089142

  • Passik SD, McDonald MV. Psychosocial aspects of upper extremity lymphedema in women treated for breast carcinoma. Cancer. 1998 Dec 15;83(12 Suppl American):2817-20. doi: 10.1002/(sici)1097-0142(19981215)83:12b+3.0.co;2-2.

    PubMed 9874404

  • Speck RM, Gross CR, Hormes JM, Ahmed RL, Lytle LA, Hwang WT, Schmitz KH. Changes in the Body Image and Relationship Scale following a one-year strength training trial for breast cancer survivors with or at risk for lymphedema. Breast Cancer Res Treat. 2010 Jun;121(2):421-30. doi: 10.1007/s10549-009-0550-7. Epub 2009 Sep 22.

    PubMed 19771507

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing combined decongestive therapy and pneumatic compression pump in people with Lymphedema, run by badri jaafari.

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 7 inclusion and 10 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

changes in the body image (time frame: change from baseline body image at 8 weeks). 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 NCT02650297, which also lists 17 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 8 Jan 2016.

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