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

Primary Purpose

Breast Cancer, Lymphedema, Perioperative/Postoperative Complications

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
hyperbaric oxygen
Sponsored by
Institute of Cancer Research, United Kingdom
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring lymphedema, radiation fibrosis, perioperative/postoperative complications, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Hospital Haslar
  • Hull Royal Infirmary
  • London Hyperbaric Medicine Limited at Whipps Cross Hospital
  • Diving Diseases Research Centre
  • Royal Marsden NHS Foundation Trust - Surrey

Outcomes

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

Full Information

First Posted
February 10, 2004
Last Updated
December 17, 2013
Sponsor
Institute of Cancer Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00077090
Brief Title
Hyperbaric Oxygen Therapy Compared With Standard Therapy in Treating Chronic Arm Lymphedema in Patients Who Have Undergone Radiation Therapy for Cancer
Official Title
Randomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Cancer Research, United Kingdom

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphedema, Perioperative/Postoperative Complications, Radiation Fibrosis
Keywords
lymphedema, radiation fibrosis, perioperative/postoperative complications, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
hyperbaric oxygen
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
99Tc-nanocolloid clearance rate as measured by quantitative lymphoscintigraphy 12 months after baseline assessment
Title
Extracellular water content as measured by EdemaMeter (bioimpedance measurements) 12 months after baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R. Yarnold, MD, FRCR
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Hospital Haslar
City
Gosport
State/Province
England
ZIP/Postal Code
PO12 2AA
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
Facility Name
London Hyperbaric Medicine Limited at Whipps Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Diving Diseases Research Centre
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8BU
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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

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