Clinical trial · Interventional
Trial of Exercise to Reduce Cancer Related Fatigue in Breast Cancer
Randomized Controlled Trial of Exercise to Reduce Cancer Related Fatigue in Women Undergoing Radiation Treatment for Breast Cancer
NCT02846389CI-TRIAL-00092484terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Like other cancer treatments, radiation therapy can make people feel fatigued, or tired. The investigators think that moderate exercise, done 15 minutes at a time, can reduce the fatigue. This study is designed to gather more information, so that in the future, doctors can recommend whether patients should engage in exercise during a radiation treatment course.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Related Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Moderate Exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Moderate Exercise
- description
- Moderate exercise - 15 minutes a day using a pedal box before or after radiation at the hospital (75 minutes a week).
- interventionNames
- Other: Moderate Exercise
- type
- NO_INTERVENTION
- label
- Control Group
- description
- No exercise
Primary outcomes (4)
- measure
- Assessment of Change in Fatigue Via Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue) Survey Instrument.
- timeFrame
- Baseline, 4 weeks into RT
- description
- The Functional Assessment of Chronic Illness Therapy (FACIT) is a 13-item subscale developed to identify a finite set of concerns specific to fatigue. The responses to the 13 items on the FACIT-Fatigue questionnaire are each measured on a 4-point likert scale, with score ranging from 0 to 52 (52 being the total score allowed). The FACIT-Fatigue scale has been validated in patients with cancer and showed excellent internal consistency and reliability. Responses to questions are scored: Not at all (0), A little bit (1), Somewhat (2) Quite a bit (3), Very much (4). Some scores are reversed depending on the question. The sum of the item scores are multiplied by the number of items in the scale, then divide by the number of items answered. This produces the score. The higher the score, the better the QOL.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. women between the ages of 18 and 75 years 2. histologically confirmed non-metastatic carcinoma of the breast (in situ disease or invasive) 3. radiation therapy naïve 4. sedentary activity level at baseline, as defined by less than 60 minutes per week of modest physical activity based on 7-day physical activity recall questionnaire 5. ambulatory 6. negative serum pregnancy test and not planning to become pregnant in the next three months 7. able to provide meaningful consent. 8. Patients must have been deemed by their medical oncologist or internist that they "may participate in \[this\] exercise trial." Prior to randomization, participants are required to complete a Physical Activity Readiness Questionnaire (PAR-Q) that includes questions regarding physical and medical conditions that would preclude safe participation in an exercise program. Exclusion Criteria: 1. younger than 18 or older than 75 years 2. no histological confirmation of breast cancer 3. prior breast, chest, or pelvic radiotherapy 4. concurrent chemotherapy 5. distant metastases 6. physical limitations that contraindicate participation in low to moderate intensity exercise 7. positive pregnancy test 8. currently engaged in moderate to vigorous physical activity 9. psychiatric disorder which would render the participant unable to provide informed consent.
References
Publications (34)
- BACKGROUNDPotthoff K, Schmidt ME, Wiskemann J, Hof H, Klassen O, Habermann N, Beckhove P, Debus J, Ulrich CM, Steindorf K. Randomized controlled trial to evaluate the effects of progressive resistance training compared to progressive muscle relaxation in breast cancer patients undergoing adjuvant radiotherapy: the BEST study. BMC Cancer. 2013 Mar 28;13:162. doi: 10.1186/1471-2407-13-162. PMID 23537231
- BACKGROUNDFisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002 Aug 22;347(8):567-75. doi: 10.1056/NEJMoa020128. PMID 12192016
- BACKGROUNDZelefsky MJ, Fuks Z, Hunt M, Yamada Y, Marion C, Ling CC, Amols H, Venkatraman ES, Leibel SA. High-dose intensity modulated radiation therapy for prostate cancer: early toxicity and biochemical outcome in 772 patients. Int J Radiat Oncol Biol Phys. 2002 Aug 1;53(5):1111-6. doi: 10.1016/s0360-3016(02)02857-2. PMID 12128109
- BACKGROUNDFisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441. PMID 9469327
- BACKGROUNDBagshaw MA, Kaplan ID, Cox RC. Prostate cancer. Radiation therapy for localized disease. Cancer. 1993 Feb 1;71(3 Suppl):939-52. doi: 10.1002/1097-0142(19930201)71:3+3.0.co;2-0. PMID 8428344
- BACKGROUNDAlcantara-Silva TR, Freitas-Junior R, Freitas NM, Machado GD. Fatigue related to radiotherapy for breast and/or gynaecological cancer: a systematic review. J Clin Nurs. 2013 Oct;22(19-20):2679-86. doi: 10.1111/jocn.12236. Epub 2013 May 8. PMID 23651041