Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2007 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on February 10, 2004. Last Updated on May 9, 2009 History of Changes

Sponsor:	Institute of Cancer Research, United Kingdom
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00077090

Purpose

RATIONALE: Hyperbaric oxygen therapy may be effective in repairing damaged tissue and reducing lymphedema caused by radiation therapy for cancer.

PURPOSE: This randomized phase II trial is studying hyperbaric oxygen to see how well it works compared to standard therapy in treating chronic arm lymphedema in patients who have undergone radiation therapy for cancer.

Condition	Intervention	Phase
Breast Cancer Lymphedema Perioperative/Postoperative Complications Radiation Fibrosis	Drug: hyperbaric oxygen	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Supportive Care
Official Title:	Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer lymphedema-distichiasis syndrome

MedlinePlus related topics: Breast Cancer Cancer Lymphedema Oxygen Therapy

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Volume of the affected limb, expressed as a percentage of the contralateral limb Volume on the day of measurement, as measured by perometer 12 months after baseline assessment

Secondary Outcome Measures:

Patient self-assessments, using specific quality of life scale in upper limb lymphoedema and the UK SF-36 Health Survey Questionnaire, at 3, 6, 9 and 12 months after baseline assessment
99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment

Estimated Enrollment:	63
Study Start Date:	April 2004

Detailed Description:

OBJECTIVES:

Primary

Compare the efficacy of hyperbaric oxygen (HBO) therapy vs standard management, in terms of reduction of lymphedema, in patients with chronic arm lymphedema after radiotherapy for cancer.

Secondary

Determine the mechanisms of tissue reperfusion and healing in patients treated with HBO therapy.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo hyperbaric oxygen therapy over 90 minutes 5 days a week for 6 weeks.
Arm II: Patients receive standard management. Patients are followed at 3, 6, 9, 12, and 15 months.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 63 patients (42 for arm I and 21 for arm II) will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

History of early breast cancer (T1-3, N0-1, M0)
Prior breast surgery with or without axillary dissection
Prior breast/chest wall radiotherapy with or without radiotherapy to the supraclavicular fossa and/or axilla, completed at least 2 years ago
Arm lymphedema
- At least 15% increase in arm volume
No evidence of cancer recurrence
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

Over 18

Sex

Female or male

Menopausal status

Not specified

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Pulmonary

No chronic obstructive airway disease
No bullous lung disease
No acute or chronic pulmonary infection
No uncontrolled asthma
No untreated pneumothorax

Other

Physically and psychologically fit for HBO therapy
No claustrophobia
No epilepsy
No eustachian tube dysfunction
No recurrent attacks of vertigo
No contraindication to MRI (e.g., intracranial ferrous material)

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

See Disease Characteristics
No prior ear operations

Other

No prior hyperbaric oxygen (HBO) therapy, except as treatment for decompression illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077090

Locations

United Kingdom
Royal Hospital Haslar
Gosport, England, United Kingdom, PO12 2AA
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
London Hyperbaric Medicine Limited at Whipps Cross Hospital
London, England, United Kingdom, E11 1NR
Diving Diseases Research Centre
Plymouth, England, United Kingdom, PL6 8BU
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT

Sponsors and Collaborators

Institute of Cancer Research, United Kingdom

Investigators

Study Chair:

John R. Yarnold, MD, FRCR

Royal Marsden NHS Foundation Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00077090 History of Changes
Other Study ID Numbers:	CDR0000349496, RMNHS-HOT, EU-20337
Study First Received:	February 10, 2004
Last Updated:	May 9, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

lymphedema
radiation fibrosis
perioperative/postoperative complications

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Fibrosis
Lymphedema
Postoperative Complications
Radiation Pneumonitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Pathologic Processes
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on February 09, 2012