Exercise Coaching for Gynecologic Cancers

(ACTIVATE Trial)

Recruiting at 3 trial locations

Overseen By Melissa Miller, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Inova Health Care Services

Disqualifiers: Unstable angina, Uncontrolled dysrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if exercise coaching can reduce fatigue in women undergoing pelvic radiation therapy for endometrial cancer. Fatigue during treatment often makes daily activities challenging, and exercise might alleviate this. The study compares the effects of starting exercise coaching during radiation therapy versus a few weeks after completing treatment. Women diagnosed with endometrial cancer, who have had a hysterectomy and plan to receive radiation therapy, might be suitable candidates. Participants must be able to walk independently and have internet access for the online program. As an unphased trial, this study provides a unique opportunity to explore innovative methods for managing treatment-related fatigue.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that exercise coaching is safe for women undergoing pelvic radiation therapy?

Research has shown that exercise is both possible and safe for women with gynecological cancers. One study found that about two-thirds of women with recurring ovarian cancer could safely exercise while receiving chemotherapy. This indicates that exercise can be manageable even during intense treatments. Additionally, exercise has been proven to improve fitness and muscle strength during cancer treatment, which can be very beneficial. Overall, these findings suggest that exercise guidance is generally safe for women undergoing treatment for gynecologic cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because exercise coaching isn't a typical approach for treating gynecologic cancers. Unlike standard treatments like surgery, chemotherapy, or radiation, this method focuses on enhancing patients' physical activity levels. The trial explores whether starting exercise coaching during or after radiation can improve recovery and overall well-being. By investigating these unique timing differences, researchers hope to find out if exercise can be an effective complementary strategy to traditional cancer treatments.

What evidence suggests that exercise coaching is effective for improving fatigue in women undergoing pelvic radiation therapy?

Research shows that exercise can help reduce tiredness in women with gynecologic cancers. Early studies indicate that exercising after cancer treatment improves fitness, strength, and flexibility. A review of studies found that people tend to exercise less after treatment, highlighting the need for organized exercise programs. Additionally, exercise is linked to a lower risk of dying from various cancers, including gynecological ones. Both exercise and mindfulness positively impact cancer-related tiredness, anxiety, and depression. In this trial, participants will be divided into two groups: the Immediate Start Group, which begins exercise coaching during the first week of radiation therapy, and the Delayed Start Group, which starts 6-8 weeks post-radiation. This setup suggests that exercise coaching might help lessen fatigue during pelvic radiation therapy. ^{1 2 3 6 7}

Who Is on the Research Team?

Avani Rao, MD

Principal Investigator

Inova Health Care Services

Are You a Good Fit for This Trial?

This trial is for women undergoing pelvic radiation therapy for endometrial cancer who experience fatigue. The study aims to see if activity coaching can help manage their fatigue during treatment.

Inclusion Criteria

Able to read, understand and provide written informed consent

I don't have any restrictions on my activities.

Patient has a computer, smart phone, or tablet virtual access to the web-based platform and email

Exclusion Criteria

I cannot attend scheduled coaching visits.

Participation in a regular exercise program of ≥150 minutes of moderate intensity exercise a week at baseline

I cannot stand up and sit down five times in a row without help.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy and Immediate Start Activity Coaching

Participants in the Immediate Start Group begin activity coaching during the first week of radiation therapy and continue through and post-completion of radiation

6-8 weeks

10 weekly check-ins (in-person or virtual)

Delayed Start Activity Coaching

Participants in the Delayed Start Group begin activity coaching 6-8 weeks post-radiation and continue 16-19 weeks post-radiation

16-19 weeks

10 weekly check-ins (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of fatigue, bowel/urinary toxicity, quality of life, cognitive function, sexual function, self-efficacy, and physical function

up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Coaching

Trial Overview

The intervention being tested is an exercise coaching program designed to alleviate fatigue in women receiving pelvic radiation therapy for gynecologic cancers, specifically focusing on its effectiveness and benefits.

How Is the Trial Designed?

Group I: Immediate Start Group Experimental Treatment 1 Intervention

Participants in this group will start the intervention during the first week of radiation therapy and continue through and post-completion of radiation

Group II: Delayed Start Group Experimental Treatment 1 Intervention

Participants in this group will start 6-8 weeks post - radiation and continue 16-19 weeks post-radiation.

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Published Research Related to This Trial

An individualized exercise program for endometrial cancer patients, starting six weeks post-surgery, showed high feasibility with 41% consent rate and 86% attendance, and no adverse events reported.

Participants experienced significant improvements in quality of life, including emotional and cognitive functioning, as well as reductions in visceral fat and increased physical fitness, with maximum weight loss of 8.4 kg after six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Effectiveness of the Exercise Program in Endometrial Cancer; Feasibility and Acceptability Survivorship Trial (EPEC-FAST). Smits, A., Galaal, K., Winnan, S., et al.[2023]

A systematic review of six studies involving 1607 participants found that physical activity levels significantly decreased after gynaecological cancer treatment, with many patients remaining less active up to three years post-diagnosis.

Approximately 91% of participants did not meet physical activity guidelines two years after diagnosis, indicating a need for targeted rehabilitation and exercise interventions for gynaecological cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of gynaecological cancer treatment on physical activity levels: a systematic review of observational studies. Lin, KY., Edbrooke, L., Granger, CL., et al.[2020]

Exercise interventions for women during or after treatment for gynaecological cancer show significant improvements in physical outcomes such as aerobic capacity, muscular strength, and agility, based on a review of 11 studies including randomized controlled trials and cohort studies.

There was no evidence that exercise worsened any outcomes, suggesting that exercise is a safe and beneficial intervention for this population, although the effects on quality of life and other measures were inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review. Rose, GL., Stewart, EM., Clifford, BK., et al.[2023]

The Exercise Harms Reporting Method (ExHaRM) was developed to systematically monitor and report adverse outcomes related to exercise in cancer survivors, addressing a gap in understanding the potential harms of exercise alongside its benefits.

ExHaRM provides a structured protocol for assessing and reporting exercise-related adverse outcomes, which can help clinicians and patients make informed decisions about exercise interventions in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical suggestions for harms reporting in exercise oncology: the Exercise Harms Reporting Method (ExHaRM). Spence, RR., Sandler, CX., Jones, TL., et al.[2023]

Engaging in physical activity (PA) for at least 150 minutes per week is linked to improved quality of life (QoL) among endometrial cancer (EC) survivors, as shown in 4 out of 5 cross-sectional studies reviewed.

Inactivity is associated with poorer QoL, particularly among obese EC survivors, highlighting the need for targeted interventions that promote physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Physical Activity on Quality of Life as Perceived by Endometrial Cancer Survivors: A Systematic Review. Babatunde, OA., Adams, SA., Orekoya, O., et al.[2022]

A review of 12 randomized controlled trials suggests that physical exercise interventions can improve fatigue, depression, and health-related quality of life in individuals with gynecologic cancer.

Despite these promising findings, the evidence is still considered preliminary due to the limited number of studies, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Physical Exercise Interventions for Individuals With Gynecologic Cancer: A Systematic Review and Meta-Analysis. Ma, RC., Li, XJ., Liu, R., et al.[2023]

In a study of 264 African-American women with epithelial ovarian cancer, recreational physical activity (RPA) before diagnosis did not show any association with mortality rates.

Post-diagnosis RPA showed a trend towards reduced mortality, with hazard ratios indicating a potential inverse relationship, although the results were not statistically significant, suggesting further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recreational physical activity and survival in African-American women with ovarian cancer. Abbott, SE., Camacho, F., Peres, LC., et al.[2022]

A survey of 239 gynecologic cancer survivors revealed a strong interest in physical activity (PA) programs, indicating a desire for structured support in their recovery.

Interviews with 16 participants emphasized the need for PA counseling that includes information on the benefits, appropriate levels of activity, and available opportunities, highlighting the role of oncology nurses in facilitating these discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The physical activity preferences of gynecologic cancer survivors. Tyrrell, A., Keats, M., Blanchard, C.[2015]

A six-month aerobic exercise program helped ovarian cancer survivors maintain their weight, while those in the control group gained weight, suggesting that exercise may be beneficial for weight management in this population.

However, the study did not find significant changes in body fat percentage, bone mineral density, or lean body mass, indicating that more precise measurement methods may be needed to assess body composition changes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on body composition among women with ovarian cancer. Cao, A., Cartmel, B., Li, FY., et al.[2023]

The ADVANCE study aims to evaluate how adverse events (AEs) are reported in exercise oncology trials, which is crucial for assessing the safety of exercise interventions for cancer patients.

By reviewing published trials and using a standardized checklist for reporting AEs, the study seeks to identify gaps in current practices and inform future research on improving the consistency and transparency of AE reporting in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Reporting of Clinical Trials in Exercise Oncology Research (ADVANCE): Protocol for a Scoping Review. Luo, H., Schumacher, O., Galvão, DA., et al.[2022]

The ECHO trial is a phase III randomized controlled trial involving 500 women with newly diagnosed ovarian cancer, aiming to assess the impact of a structured exercise program on progression-free survival and physical well-being during first-line chemotherapy.

Participants in the exercise group will engage in 150 minutes of moderate-intensity exercise weekly, with outcomes including not only cancer progression but also quality of life, fatigue, and overall health, highlighting the potential benefits of exercise in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during CHemotherapy for Ovarian cancer (ECHO) trial: design and implementation of a randomised controlled trial. Hayes, S., Obermair, A., Mileshkin, L., et al.[2023]

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