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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00077090
First received: February 10, 2004
Last updated: December 17, 2013
Last verified: September 2007
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: December 17, 2013
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
Breast Diseases
Lung Diseases
Lung Diseases, Interstitial
Lung Injury
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Radiation Injuries
Respiratory Tract Diseases
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014