Anatomic Stage 0 Breast Cancer AJCC v8NCT06297265
Manual Lymphatic Drainage Breast Massage in Breast Cancer Patients After Breast Conserving Surgery
A study testing Lymphedema Management, Questionnaire Administration and Adjuvant breast radiation therapy in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of Southern California at 1 site in United States.
Trial summary
This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Localized Breast Carcinoma
- What is being tested?
- Lymphedema Management, Questionnaire Administration and Adjuvant breast radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation
- Age >= 18 years
- Ability to understand and the willingness to sign a written informed consent in English or Spanish
Who cannot join
- Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Inability to provide written informed consent in English or Spanish
- Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Kimberly Arieli, RN, 323-865-0451, Kimberly.Arieli@med.usc.edu
May L. Tao, MD
About this study
Official title: Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy
This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.
SECONDARY OBJECTIVES:
- Evaluate the tolerability of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.
II. Preliminarily assess the effect on acute and chronic breast edema, pain, functional status, quality of life, body image and radiation induced fibrosis (RIF).
OUTLINE:
Patients undergo MLD breast massage over 30-60 minutes twice a week (BIW) for the duration of standard of care (SOC) radiation therapy and for 1 month thereafter.
After completion of SOC radiation therapy, patients are followed up at 2-4 weeks and 3, 6, and 12 months.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Localized Breast Carcinoma
- Being tested
- Lymphedema Management, Questionnaire Administration, Adjuvant breast radiation therapy
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphedema ManagementOther
Undergo MLD breast massage
Questionnaire AdministrationOther
Ancillary studies
Adjuvant breast radiation therapyRadiation
Also called Radiotherapy
Using standard 3D conformal or intensity modulated techniques, patients will receive standard fractionation or moderate hypofractionation radiation therapy. The radiation treatment will last for 3 to 6 weeks, with the length of treatment depending on patient's specific clinical situation.
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (MLD breast massage) | Experimental | Patients undergo MLD breast massage over 30-60 minutes BIW for the duration of SOC radiation therapy and for 1 month thereafter. Receives: Other: Lymphedema Management; Other: Questionnaire Administration; Radiation: Adjuvant breast radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of compliance of MLD breast massage sessions
The intervention compliance rate will be calculated as the percentage of completed treatment sessions over the total targeted treatment sessions.
Measured: Up to 1 month after completion of radiation
Secondary outcomes (5)
Assess the effect of MLD breast massage breast edema
The Dutch Breast Edema Questionnaire (BrEQ-Dutch version) will be used to diagnose the presence of breast edema. Getting 8.5 points from the questionnaire is the cut-off point. There is no breast edema below 8.5, there is breast edema above 8.5. It has a score between 0-80 points. Higher total symptom score means worse edema.
Measured: Up to 1 year
Assess the effect of MLD breast massage on pain
Pain will be graded using NCI-CTCAE version 5.0
Measured: Up to 1 year
Assess the effect of MLD breast massage on functional status
Will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148 The higher the score, the better the QOL reported by the participant.
Measured: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
Assess the effect of MLD breast massage on quality of life
Quality of Life will be assessed using the European Quality of Life 5 Dimension 5 Level (EuroQoL EQ-5D-5L) questionnaire. The questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems (1-5). The patient is asked to indicate her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. A higher score indicates more severe or frequent problems.
Measured: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
Assess the effect of MLD breast massage on body image
Will be assessed using the Body Image Scale (BIS). The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance.
Measured: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start24 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- May L Tao, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297265
- Sponsor's protocol ID
- 1B-23-2
- Other IDs
- NCI-2023-10828, 1B-23-2, P30CA014089
- Status last verified
- May 2026
- First submitted
- 9 Feb 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of Manual Lymphatic Drainage (MLD) Breast Massage in Breast Cancer Patients Undergoing Adjuvant Radiation Therapy
- ClinicalTrials.gov ID
- NCT06297265
- Acronym / sponsor ID
- 1B-23-2
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Localized Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial evaluates manual lymphatic drainage breast massage for reducing treatment-related side effects in women undergoing radiation therapy after breast conserving surgery for breast cancer that has not spread to other parts of the body (localized). Breast conserving surgery can be an effective treatment option for early stage breast cancer, but it can also be associated with side effects including fluid collection in tissues/swelling (lymphedema), pain, reduced quality of life, and poorer body image. Manual lymphatic drainage is a gentle massage technique used to reduce swelling. It may be a safe and effective way to reduce treatment-related side effects in women receiving radiation therapy after surgery for localized breast cancer.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate the feasibility of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.
SECONDARY OBJECTIVES:
- Evaluate the tolerability of breast manual lymphatic drainage (MLD) on breast cancer patients receiving adjuvant breast radiation therapy after breast conserving surgery.
II. Preliminarily assess the effect on acute and chronic breast edema, pain, functional status, quality of life, body image and radiation induced fibrosis (RIF).
OUTLINE:
Patients undergo MLD breast massage over 30-60 minutes twice a week (BIW) for the duration of standard of care (SOC) radiation therapy and for 1 month thereafter.
After completion of SOC radiation therapy, patients are followed up at 2-4 weeks and 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (MLD breast massage) | Experimental | Other: Lymphedema Management, Other: Questionnaire Administration, Radiation: Adjuvant breast radiation therapyPatients undergo MLD breast massage over 30-60 minutes BIW for the duration of SOC radiation therapy and for 1 month thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female with native breasts and localized breast cancer who are status post-lumpectomy surgery, will receive whole breast radiation therapy with/without nodal irradiation, with standard fractionation or moderate hypofractionation
- Age >= 18 years
- Ability to understand and the willingness to sign a written informed consent in English or Spanish
Key exclusion criteria (4 listed)
- Underlying diagnosis of chronic inflammatory illness or collagen vascular disorder, e.g. scleroderma, lupus, rheumatoid arthritis, fibromyalgia as these conditions may significantly affect the likelihood and magnitude of radiation related toxicity
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Inability to provide written informed consent in English or Spanish
- Patients receiving ultra-hypofractionation, and/or partial breast or chest wall radiation therapy are excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphedema ManagementUndergo MLD breast massage | Other | Supportive care (MLD breast massage) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (MLD breast massage) |
| Adjuvant breast radiation therapyAlso: RadiotherapyUsing standard 3D conformal or intensity modulated techniques, patients will receive standard fractionation or moderate hypofractionation radiation therapy. The radiation treatment will last for 3 to 6 weeks, with the length of treatment depending on patient's specific clinical situation. | Radiation | Supportive care (MLD breast massage) |
Primary outcome
Rate of compliance of MLD breast massage sessions
Time frame: Up to 1 month after completion of radiation
The intervention compliance rate will be calculated as the percentage of completed treatment sessions over the total targeted treatment sessions.
5 secondary outcomes
Assess the effect of MLD breast massage breast edema
Time frame: Up to 1 year
Assess the effect of MLD breast massage on pain
Time frame: Up to 1 year
Assess the effect of MLD breast massage on functional status
Time frame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
Assess the effect of MLD breast massage on quality of life
Time frame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
Assess the effect of MLD breast massage on body image
Time frame: From baseline to follow-up (2-4 weeks, and 3, 6, and 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
May L Tao, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphedema Management, Questionnaire Administration and Adjuvant breast radiation therapy in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Arieli, RN (323-865-0451, Kimberly.Arieli@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of compliance of MLD breast massage sessions (time frame: Up to 1 month after completion of radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.