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

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What is being tested

Data Collection

Who is being recruted

Radiation Fibrosis Syndrome
+10

+ Breast Diseases
+ Breast Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorInstitute of Cancer Research, United Kingdom
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

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.

Official TitleRandomized Phase II Trial Of Hyperbaric Oxygen Therapy In Patients With Chronic Arm Lymphoedema After Radiotherapy For Cancer 
NCT00077090
Principal SponsorInstitute of Cancer Research, United Kingdom
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
63 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Radiation Fibrosis Syndrome
Breast Diseases
Breast Neoplasms
Fibrosis
Lymphatic Diseases
Lymphedema
Neoplasms
Neoplasms by Site
Pathologic Processes
Postoperative Complications
Radiation Injuries
Skin Diseases
Wounds and Injuries
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 5 locations
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Royal Hospital HaslarGosport, United KingdomSee the location
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Hull Royal InfirmaryHull, United Kingdom
Suspended
London Hyperbaric Medicine Limited at Whipps Cross HospitalLondon, United Kingdom
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Diving Diseases Research CentrePlymouth, United Kingdom
Suspended5 Study Centers
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