Hyperbaric Oxygen Therapy Compared With Standard Therapy... | NCT00077090

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Feb 10, 2004

First Submission Date that Met QC Criteria

Feb 10, 2004

First Posted Date

Feb 11, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2013

Last Update Posted Date

Dec 18, 2013Estimated

Description Module

Brief 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.

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.

Name	Type	Description	Arm Group Labels	Other Names
hyperbaric oxygen	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Type	Description	Link
RMNHS-HOT
EU-20337

Facility	Status	City	State	ZIP	Country	Contacts
Royal Hospital Haslar		Gosport	England	PO12 2AA	United Kingdom
Hull Royal Infirmary

ID	Term
D001943	Breast Neoplasms
D008209	Lymphedema
D011183	Postoperative Complications
D000087525	Radiation Fibrosis Syndrome

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005355	Fibrosis
D011832	Radiation Injuries
D014947	Wounds and Injuries

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics