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

Breast Cancer Clinical Trial

Official title:

Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00077090
• Other study ID #: CDR0000349496
• Secondary ID: RMNHS-HOTEU-2033
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 10, 2004
• Last updated: December 17, 2013
• Start date: April 2004

Study information

• Verified date: September 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Lymphedema
• Perioperative/Postoperative Complications
• Postoperative Complications
• Radiation Fibrosis
• Radiation Pneumonitis

Intervention

Drug:
• hyperbaric oxygen

Locations

Country	Name	City	State
United Kingdom	Royal Hospital Haslar	Gosport	England
United Kingdom	Hull Royal Infirmary	Hull	England
United Kingdom	London Hyperbaric Medicine Limited at Whipps Cross Hospital	London	England
United Kingdom	Diving Diseases Research Centre	Plymouth	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
Secondary	Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment