Efficacy of Massage for the Treatment of Cancer-Related Fatigue (CRF) in Prostate Cancer Survivors

NCT03187275 | Completed DMC

• 1 other identifier: IRB00095260
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer-related fatigue (CRF) is a prevalent and debilitating symptom experienced by cancer survivors. CRF can persist for months or years after cancer therapy is completed and has a negative impact on all areas of mental and physical function. Treatment options for CRF are extremely limited and finding safe, inexpensive, and effective interventions for managing this distressing symptom are urgently needed. Massage therapy is one of the fastest growing complementary therapies. A recently completed study in breast cancer survivors with CRF found that Swedish Massage Therapy (SMT) caused a significant reduction in fatigue and improvement in quality of life. This study investigates the effects of massage therapy on CRF among prostate cancer survivors. The study will evaluate whether SMT improves quality of life, depression, and anxiety. Second, this study will evaluate if SMT reduces CRF by decreasing the pro-inflammatory cytokine Interleukin-6 (IL-6). Lastly, to establish measures of reduced fatigue beyond self report at the treatment visits, the researchers will implement continuous, real-time monitoring of physiologic and psychological signs and symptoms, throughout the treatment period. This study will improve care for CRF and other hard-to-manage symptoms of cancer treatment and provide preliminary evidence of immune modulation as a potential mechanism of action. This study is a randomized clinical trial to test the efficacy of Swedish massage therapy (SMT) versus an active control condition (light touch, LT) on cancer related fatigue in men with prostatic cancer, at least 2 months after the end of their radiation therapy. The primary outcome is the Multidimensional Fatigue Inventory (MFI). Secondary outcomes are the Patient-Reported Outcomes Measurement System (PROMIS) Fatigue Scale, plasma concentrations of cytokine IL-6, self-reported quality of life, depression, and anxiety, wearable measures of activity and sleep, and Automated Monitoring of Symptom Severity (AMoSS) ratings.

Conditions

Cancer-related Problem/Condition

Keywords

Cancer Related Fatigue (CRF); Prostate Cancer; Swedish Massage Therapy (SMT); Cancer; Quality of Life (QOL)

Outcome Measures

Primary Outcomes (1)

• Change in Multidimensional Fatigue Inventory (MFI) score

  Multidimensional Fatigue Inventory (MFI) is a brief (20-item) self-report instrument that assesses 5 dimensions (subscales) of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Respondents indicate their level of agreement with fatigue related statements on a 5 point scale ranging from "Yes, that is true" = 1 to "No that is not true" = 5. Possible scores for each subscale range from 4 (no fatigue) to 20 (maximum fatigue). The primary outcome measure for this study will be the total of four MFI subscales (general fatigue, physical fatigue, reduced activity, and reduced motivation).

  Baseline, Week 6

Secondary Outcomes (10)

• Change in Patient-Reported Outcome Measurement System (PROMIS) Fatigue Scale score

  Baseline, Week 6

• Change in plasma IL-6

  Baseline, Week 6

• Change in Quality of Life, Enjoyment, and Satisfaction Questionnaire - short form (Q-LES-Q) score

  Baseline, Week 6

• Change in Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) score

  Baseline, Week 6

• Change in Generalized Anxiety Disorder 7-item (GAD-7) Scale score

  Baseline, Week 6

Study Arms (2)

Swedish Massage Therapy

EXPERIMENTAL

Participants in this arm will receive Swedish massage, which is the most commonly offered and best-known type of massage.

Other: Swedish Massage Therapy

Light Touch Intervention

ACTIVE COMPARATOR

Participants in this arm will receive light touch only.

Other: Light Touch Intervention

Interventions

Swedish Massage Therapy OTHER

The therapist uses non-aromatic massage oil to facilitate making long, smooth strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called "draping." One part of the body is uncovered, massaged, and then covered up before moving onto another part of the body. Primary techniques used in the research protocol therapy are: effleurage, petrissage, tapotement. These will be administered according to a very specific, standardized protocol. The total session time will be 45 minutes.

Also known as: SMT

Swedish Massage Therapy

Light Touch Intervention OTHER

The light-touch research intervention is based on the concept that there will be a noticeable effect with regard to massage when compared to light-touch alone without the massage. The protocol followed will be the same as the massage protocol other than that the therapist will use light-touch only. The total session time will be 45 minutes.

Also known as: LT

Light Touch Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of prostate cancer
• At least 2 months after the end of radiation therapy
• Brief Fatigue Inventory (BFI) score of \>25
• Satisfactory results of screening safety labs, serum testosterone test and drug test
• Ability to understand study procedures and to comply with them for the entire length of the study

You may not qualify if:

• Inability to lay supine for one hour at a time, given the nature of the massage intervention
• Actively suicidal or homicidal
• Medical conditions felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment: anemia (hemoglobin less than 10 g/dl), hypothyroidism (thyroid stimulating hormone greater than 4.6 microUnits per milliliter (mcU/mL)), uncontrolled pain, or medical problems associated with fatigue, including: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and poorly controlled sleep apnea
• Medications felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment. Those may include: antidepressants, chronic use of long-acting anxiolytics or neuroleptics
• Treatment with high dose systemic corticosteroids or continuous use of other immunosuppressants within the past 30 days
• Unable to comply with the protocol for any reason
• Use of non-steroidal anti-inflammatory drugs; aspirin use is allowed but must be tracked
• Illicit drug use
• Shift work
• Currently dieting
• Excessive, regular use of alcohol (more than two 5 ounce glasses of wine or equivalents/day) or a history of binge drinking (more than 7 drinks/24 hour period) within the last 6 months
• Have used massage as a therapeutic modality (medical or psychological) at any point for the treatment of medical conditions
• Have massages on a regular basis, defined as receiving 4 or more massages per year for the last 5 years
• Currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem
• Unable to read and understand the informed consent document because of language difficulties

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Executive Park 12

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Mark Rapaport, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 14, 2017
• Study Start: January 22, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

US (1)