An interventional study of Massage therapy in Breast Cancer and Fatigue in Cancer Survivors, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
The purpose of this study is to better understand how massage therapy helps reduce fatigue related to cancer and its treatment in breast cancer survivors.
The study will utilize a randomized waitlist-controlled design to assess symptomatic changes, generating mechanistic insights into MT. Participants in the intervention arm will receive a 30-minute massage twice a week, for three weeks. Waitlist participants will complete all NON-Massage Therapy study assessments during the active study phase at the same time points as the intervention group.
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This study's planned enrollment of 34 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the active study phase, a 30-minute massage twice a week, for three weeks with pressure guided by the Walton Pressure Scale (WPS) and fidelity monitored using an Oncology Massage Therapy (OMT) checklist. Study assessments will also be given.
Procedure: Massage therapy
Complete all Non-Massage Therapy study assessments during the active study phase at the same time points as the intervention group enabling comparisons of symptom change over the same period. The waitlist control arm will receive MT during the non-active study phase.
Massage therapy will consist of Swedish techniques modified for oncology massage, including stroking, compression, and percussion. Hands-on techniques include varied combinations of effleurage, petrissage, friction, tapotement, and vibration. Pressure is measured using the validated WPS, ranging from 1 (light) to 3 (medium), as needed. For the purposes of this study, the therapist will not exceed WPS 3, as this is generally perceive this level of pressure as pleasant and relaxing, thereby fostering trust.
Patient-Reported Fatigue Score
The patient-reported fatigue score, obtained from the PROMIS F-SF 7b, is a continuous variable measured on a 5-point scale (1-5), where 1 indicates never, and 5 indicates always, with a 24-hour recall. The PROMIS F-SF 7b includes 7 items that assess the participant's fatigue intensity, frequency, and interference with daily activities. Item responses are summed to generate a raw score ranging from 7 to 35, with higher scores indicating greater fatigue severity. Raw scores will be converted to standardized PROMIS T scores using the official table, resulting in T-scores ranging from 31.0 to 81.4, with higher scores indicating greater fatigue severity.
Time frame: Twice weekly for 3 weeks, including baseline before massage therapy (pre-MT), and at 4 weeks post-massage therapy (post-MT)
Objective fatigue score
The objective fatigue score, obtained from the six-minute walk test (6MWT), is a continuous variable measured in meters and serves as an objective measure of fatigue and physical performance. The score reflects the distance the participant can walk in six minutes, as assessed by a trained designee. Higher values indicate better physical performance and lower levels of objective fatigue.
Time frame: Twice weekly for 3 weeks, including baseline before pre-MT, and at 4 weeks post-MT
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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