Pancreatic CancerEarly Phase 1NCT00902759
Fatigue and Pancreas and Bile Duct Cancer Study
A Early Phase 1 study testing Walking Program in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine the effects of a walking program on fatigue, physical functioning and QOL in patients with pancreatic and periampullary cancers who have had surgery or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation therapy (RT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Walking Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2009to 15 Apr 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed pathologic diagnosis of adenocarcinoma of pancreas or periampullary cancers, Stage I, II, or III
- Treatment included surgery alone, or adjuvant treatment with CT and/or RT
- Men and women ≥ 18 years of age
- Residents of the USA
- Surgery performed at TJUH, Philadelphia, PA
- CT or RT performed at TJUH, Jefferson system affiliate hospital, or elsewhere
- Patients receiving neoadjuvant therapy with CT or RT, or both, who subsequently are re-staged and eligible for surgery
Who cannot join
- The presence of co-morbidities that would preclude involvement in a walking program (wheelchair bound, severe arthritis, dizziness)
- Primary residence outside the USA
- Medical management alone for pancreas or periampullary cancer (i.e. not a surgical candidate)
- Stage IV (metastatic) cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Fatigue, Physical Functioning, and Quality of Life in Patients With Pancreatic and Periampullary Cancers Following Surgery, Chemotherapy, and/or Radiation Therapy
The purpose of this pilot study is to determine the effects of a walking program on fatigue, physical functioning and QOL in patients with pancreatic and periampullary cancers who have had surgery or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation therapy (RT). This pilot study will utilize the walking program developed by Mock et al. (2001), in their investigation of the improvement of fatigue and QOL in breast care patients following surgery who were receiving CT, RT or biotherapy. No studies published to date have utilized a progressive walking program in post-operative pancreas and ampullary cancers to determine if it reduces adverse effects, such as fatigue or improves functionality and QOL scores.
Read the detailed description
Pancreatic cancer (PC) is the fourth leading cause of cancer death in men and fifth in women in the US (Jemal, Sigel, Ward, Murray, Xu, Thun et al., 2007). According to the American Cancer Society, the reported incidence of PC is roughly 37,000 cases per year, with approximately 33,000 annual deaths (2007). Periampullary cancers are less common; there were 9,250 incident cancers of the biliary tract in 2007, with 3,250 resultant deaths (Jemal et al., 2007).
Five-year survival rates for untreated PC and periampullary cancers are poor, approximately 4%. Surgery offers the only hope of a cure for these patients. Following resection, the reported median survival is 12-18 months, with a five-year survival of 10-40% for patients with PC (Cleary, Gryfe, Guindi, 2004; Ishikawa, Ohihashi, Yamada, Sasaki, Imaoka, Nakaizumi et al., 2002; Sohn, Yeo, Cameron, Koniarais, Kaushal, Abrams, et al., 2000; \& Conlon, Klimstra, \& Brennan, 1996) and somewhat higher rates for patients with periampullary cancers. Five-year post-resection survival rates may approach 40% when performed at specialized major medical institutions and when favorable pathologic predictors are identified (Sohn et al.). In recent years, improved post-resection survival is due in part to lower perioperative mortality, and partially due to aggressive resection of early, low stage tumors. Long-term survival is considerably lower when resection is performed at low volume pancreatic surgery institutions and postoperative mortality is significantly higher (Birkmeyer, Siewers, Finlayson, Stukel, Lucas, Batista, et al., 2002).
As patients with pancreatic and periampullary cancers experience improved survival rates and live longer, issues regarding adverse symptoms, physical function and quality of life become more important. Fatigue and pain are commonly reported symptoms in patients undergoing CT and RT, with fatigue the most universally reported symptom (Given, Given, McCorkle, Kozachik, Cimprich, Rahbar, Wojcik, 20002). Fatigue can lead to a decrease in activity levels and in one's overall QOL. Exercise has been found to effectively decrease fatigue levels and improve functional capacity in patients with breast and prostate cancer (Mock, Pickett, Ropka, Lin, Rhodes, McDaniel, et al. 2001; Segal, R., Reid, R., Courneya, K, Malone, S., Parliament, M., Scott, C., et al., 2003; MacVicar, Winningham, \& Nickel, 1989).
No study to date has reported on the effects of an exercise program on fatigue levels, physical functioning or QOL in post-operative pancreatic and periampullary cancer patients.
This pilot study will employ a quasi-experimental study design that is prospective in nature and randomizes patients to either the intervention group or the usual care group.
Participants will complete the Piper Fatigue Scale (PFS) and the MOS SF-36 QOL questionnaire post-operatively prior to hospital discharge or at the first office visit, and again at the end of six months or at the conclusion of adjuvant treatment.
- Conditions
- Pancreatic Cancer
- Being tested
- Walking Program
- Keywords
- Surgery, Chemotherapy, Radiation Therapy, Pancreatic cancer, Fatigue
- Medical subject headings
- Pancreatic Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking ProgramOther
"Brisk" walking is defined as faster than the slow walk, but not to exhaustion and not a running pace. Participants will be instructed to walk at home, at a gym or in a shopping mall for as far as possible on a level surface, wearing appropriate footwear as described in the walking booklet. (Patients may continue to walking longer if they desire and are symptom free). Participants should stop or slow down if they experience any discomfort (such as uncomfortable shortness of breath, chest pain, or body pain). The goal is to eventually walk for 90-120 minutes per week in three to four sessions. Participants will not be asked to take their pulse or to record their perceived exertion in order to simplify the program.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group | No intervention | Participants randomized to the usual care group will be encouraged to return to their "usual" or pre-surgical levels of activity. Usual care of post-surgical PC and peri-ampullary patients typically includes encouragement to walk and be active as they can be by the surgeons, surgical nurses and the nurse practitioners. Participants in the usual care group will not receive an individual "Exercise Prescription" at the time of entry. The usual care group will perform a baseline walk. Participants in the usual care group will not receive an individual "Exercise Prescription" at the time of entry nor will they will a telephone call every month. Repeat questionnaires will be performed at 6 months. |
| Walking Program | Experimental | Participants in the intervention arm will participate in a walking program consisting of a 6 week graduated walking program. There are three phases to the walking program, Phase 1 is Warm-up, Phase 2 is Brisk Walking and Phase 3 is Cool Down. Phase 1 is the same for all 6 weeks, and consists of a slow 5 minute walk. In Months 1 and 2, Phase 2 is a 10 minute brisk walk. In Months 3 and 4, Phase 2 is a 20 minute brisk walk. In Months 5 and 6, Phase 2 is a 25 - 30 minute brisk walk. Phase 3 is the same for all 6 weeks and consists of a 5 minute rest/cool down period. Receives: Other: Walking Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires
Questionnaires will be completed after surgery but prior to initiation of chemotherapy (CT) or radiation therapy (RT) and again 6 months after hospital discharge or at the completion of adjuvant therapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study start9 Jan 2009
- Primary completion7 Jan 2011
- Study completion15 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theresa Yeo, PhD, MPH, MSN, AOCNP, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902759
- Sponsor's protocol ID
- 08D.574
- Other IDs
- 2008-37, JT 1371
- Status last verified
- May 2025
- First submitted
- 13 May 2009
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Yeo TP, Burrell SA, Sauter PK, Kennedy EP, Lavu H, Leiby BE, Yeo CJ. A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll Surg. 2012 Apr;214(4):463-75; discussion 475-7. doi: 10.1016/j.jamcollsurg.2011.12.017. Epub 2012 Feb 7.
PubMed 22321518
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue, Physical Functioning, and Quality of Life in Patients With Pancreatic and Periampullary Cancers Following Surgery, Chemotherapy, and/or Radiation Therapy
- ClinicalTrials.gov ID
- NCT00902759
- Acronym / sponsor ID
- 08D.574
- Conditions
- Pancreatic Cancer
- Keywords
- Surgery, Chemotherapy, Radiation Therapy, Pancreatic cancer, Fatigue
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 9 Jan 2009 (actual)
- Primary completion
- 7 Jan 2011 (actual)
- Study completion
- 15 Apr 2015 (actual)
- First posted
- 15 May 2009 (estimated)
- 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.
The purpose of this pilot study is to determine the effects of a walking program on fatigue, physical functioning and QOL in patients with pancreatic and periampullary cancers who have had surgery or are undergoing adjuvant therapy with chemotherapy (CT) and/or radiation therapy (RT). This pilot study will utilize the walking program developed by Mock et al. (2001), in their investigation of the improvement of fatigue and QOL in breast care patients following surgery who were receiving CT, RT or biotherapy. No studies published to date have utilized a progressive walking program in post-operative pancreas and ampullary cancers to determine if it reduces adverse effects, such as fatigue or improves functionality and QOL scores.
Detailed description
Pancreatic cancer (PC) is the fourth leading cause of cancer death in men and fifth in women in the US (Jemal, Sigel, Ward, Murray, Xu, Thun et al., 2007). According to the American Cancer Society, the reported incidence of PC is roughly 37,000 cases per year, with approximately 33,000 annual deaths (2007). Periampullary cancers are less common; there were 9,250 incident cancers of the biliary tract in 2007, with 3,250 resultant deaths (Jemal et al., 2007).
Five-year survival rates for untreated PC and periampullary cancers are poor, approximately 4%. Surgery offers the only hope of a cure for these patients. Following resection, the reported median survival is 12-18 months, with a five-year survival of 10-40% for patients with PC (Cleary, Gryfe, Guindi, 2004; Ishikawa, Ohihashi, Yamada, Sasaki, Imaoka, Nakaizumi et al., 2002; Sohn, Yeo, Cameron, Koniarais, Kaushal, Abrams, et al., 2000; \& Conlon, Klimstra, \& Brennan, 1996) and somewhat higher rates for patients with periampullary cancers. Five-year post-resection survival rates may approach 40% when performed at specialized major medical institutions and when favorable pathologic predictors are identified (Sohn et al.). In recent years, improved post-resection survival is due in part to lower perioperative mortality, and partially due to aggressive resection of early, low stage tumors. Long-term survival is considerably lower when resection is performed at low volume pancreatic surgery institutions and postoperative mortality is significantly higher (Birkmeyer, Siewers, Finlayson, Stukel, Lucas, Batista, et al., 2002).
As patients with pancreatic and periampullary cancers experience improved survival rates and live longer, issues regarding adverse symptoms, physical function and quality of life become more important. Fatigue and pain are commonly reported symptoms in patients undergoing CT and RT, with fatigue the most universally reported symptom (Given, Given, McCorkle, Kozachik, Cimprich, Rahbar, Wojcik, 20002). Fatigue can lead to a decrease in activity levels and in one's overall QOL. Exercise has been found to effectively decrease fatigue levels and improve functional capacity in patients with breast and prostate cancer (Mock, Pickett, Ropka, Lin, Rhodes, McDaniel, et al. 2001; Segal, R., Reid, R., Courneya, K, Malone, S., Parliament, M., Scott, C., et al., 2003; MacVicar, Winningham, \& Nickel, 1989).
No study to date has reported on the effects of an exercise program on fatigue levels, physical functioning or QOL in post-operative pancreatic and periampullary cancer patients.
This pilot study will employ a quasi-experimental study design that is prospective in nature and randomizes patients to either the intervention group or the usual care group.
Participants will complete the Piper Fatigue Scale (PFS) and the MOS SF-36 QOL questionnaire post-operatively prior to hospital discharge or at the first office visit, and again at the end of six months or at the conclusion of adjuvant treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group | No intervention | –Participants randomized to the usual care group will be encouraged to return to their "usual" or pre-surgical levels of activity. Usual care of post-surgical PC and peri-ampullary patients typically includes encouragement to walk and be active as they can be by the surgeons, surgical nurses and the nurse practitioners. Participants in the usual care group will not receive an individual "Exercise Prescription" at the time of entry. The usual care group will perform a baseline walk. Participants in the usual care group will not receive an individual "Exercise Prescription" at the time of entry nor will they will a telephone call every month. Repeat questionnaires will be performed at 6 months. |
| Walking Program | Experimental | Other: Walking ProgramParticipants in the intervention arm will participate in a walking program consisting of a 6 week graduated walking program. There are three phases to the walking program, Phase 1 is Warm-up, Phase 2 is Brisk Walking and Phase 3 is Cool Down. Phase 1 is the same for all 6 weeks, and consists of a slow 5 minute walk. In Months 1 and 2, Phase 2 is a 10 minute brisk walk. In Months 3 and 4, Phase 2 is a 20 minute brisk walk. In Months 5 and 6, Phase 2 is a 25 - 30 minute brisk walk. Phase 3 is the same for all 6 weeks and consists of a 5 minute rest/cool down period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed pathologic diagnosis of adenocarcinoma of pancreas or periampullary cancers, Stage I, II, or III
- Treatment included surgery alone, or adjuvant treatment with CT and/or RT
- Men and women ≥ 18 years of age
- Residents of the USA
- Surgery performed at TJUH, Philadelphia, PA
Key exclusion criteria (4 listed)
- The presence of co-morbidities that would preclude involvement in a walking program (wheelchair bound, severe arthritis, dizziness)
- Primary residence outside the USA
- Medical management alone for pancreas or periampullary cancer (i.e. not a surgical candidate)
- Stage IV (metastatic) cancer
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 |
|---|---|---|
| Walking Program"Brisk" walking is defined as faster than the slow walk, but not to exhaustion and not a running pace. Participants will be instructed to walk at home, at a gym or in a shopping mall for as far as possible on a level surface, wearing appropriate footwear as described in the walking booklet. (Patients may continue to walking longer if they desire and are symptom free). Participants should stop or slow down if they experience any discomfort (such as uncomfortable shortness of breath, chest pain, or body pain). The goal is to eventually walk for 90-120 minutes per week in three to four sessions. Participants will not be asked to take their pulse or to record their perceived exertion in order to simplify the program. | Other | Walking Program |
Primary outcome
FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires
Time frame: 6 months
Questionnaires will be completed after surgery but prior to initiation of chemotherapy (CT) or radiation therapy (RT) and again 6 months after hospital discharge or at the completion of adjuvant therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Derived from this study: PubMed 22321518Yeo TP, Burrell SA, Sauter PK, Kennedy EP, Lavu H, Leiby BE, Yeo CJ. A progressive postresection walking program significantly improves fatigue and health-related quality of life in pancreas and periampullary cancer patients. J Am Coll Surg. 2012 Apr;214(4):463-75; discussion 475-7. doi: 10.1016/j.jamcollsurg.2011.12.017. Epub 2012 Feb 7.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Theresa Yeo, PhD, MPH, MSN, AOCNP principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Walking Program in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 7 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: finished, as of the sponsor's last update on 2 May 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT (Facit Fatigue Scale) and Medical Outcomes Study Short Form-36 (MOS-SF-36) questionnaires (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902759, which also lists 1 linked publication.
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 2 May 2025.