Short-Term Fasting: Impact on Toxicity

NCT00936364 | Terminated DMC

• 1 other identifier: 0S-08-9
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This partially randomized clinical trial studies short-term fasting in reducing side effects in patients receiving gemcitabine hydrochloride and cisplatin for advanced solid tumors. Short-term fasting before chemotherapy may reduce the side effects caused by chemotherapy. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

Fasting in Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Identification of the longest duration of fasting which is safe

  Up to 5 years

Secondary Outcomes (3)

• Significant toxicity as assessed by CTCAE v3.0

  Up to 5 years

• Changes in plasma insulin, glucose, IGF1 and IGF binding protein (IGFBP) levels, and GRP78 expression in WBCs

  Up to 2 courses

• Changes in grp78 expression after fasting and after chemotherapy administration

  After 2 courses

Study Arms (4)

Group I (Stage I of study)

EXPERIMENTAL

Patients fast for 24 hours on day -1

Other: Short-term fasting; Other: Fasting

Group II (Stage I of study)

EXPERIMENTAL

Patients fast for 48 hours on days -2 and -1

Other: Short-term fasting; Other: Fasting

Group III (Stage I of study)

EXPERIMENTAL

Patients fast for 72 hours on days -3, -2, and -1

Other: Short-term fasting; Other: Fasting

Group IV (Stage I of study)

EXPERIMENTAL

Patients undergo a modified 48-hour fast with minimal caloric intake on day -2 and -1

Other: Modified fast; Other: Fasting

Interventions

Short-term fasting OTHER

No calories will be consumed during periods of fasting. Good oral hydration will be encouraged. Water may be consumed, as well as non-caloric beverages (i.e. zero calorie soft drinks, black coffee or tea).

Also known as: fasting

Group I (Stage I of study); Group II (Stage I of study); Group III (Stage I of study)

Modified fast OTHER

Minimal caloric intake on days -2 and -1

Also known as: fasting

Group IV (Stage I of study)

Fasting OTHER

Day -1

Group I (Stage I of study)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Histologically confirmed malignancy for which platinum-based chemotherapy on a 21 day cycle or 14 day cycle is being recommended.
• Disease state:
• Stage I of the trial: newly diagnosed disease for which neoadjuvant or adjuvant chemotherapy is planned in the curative setting, or metastatic disease.
• Stage II of the trial: Measurable disease by RECIST criteria must be present for all subjects in the randomized component of the trial- if surgery or radiation is planned, the target lesions may not be so treated until after the assessment of the effect of chemotherapy.
• Prior chemotherapy
• Stage I: subjects may have already received no more than 2 cycle of platinum-based chemotherapy, but should not have received other prior chemotherapy regimens with the exception of patients with metastatic disease who received neoadjuvant or adjuvant chemotherapy and that chemotherapy was completed \> 6 months prior to enrollment.
• Stage II: subjects must have received no prior chemotherapy regimens for metastatic disease, and no more than 2 cycles of their current platinum chemotherapy regimen for metastatic disease. They may have received prior neoadjuvant or adjuvant chemotherapy, provided such therapy was completed \>6 months prior to enrollment.
• Prior Radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment.
• BMI \> 18.5
• ECOG performance status 0-1
• Adequate renal function (Creatinine \<1.25 ULIN or calculated creatinine clearance \> 50 ml/min)
• Premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period.

You may not qualify if:

• Diabetes Mellitus
• Recent significant or unexplained weight loss that the investigator feels may pose an unacceptable risk for enrollment. Candidates who are overweight and have lost weight intentionally via diet or exercise should not be excluded.
• Peripheral Neuropathy \> grade 1
• History of significant cardiac disease, particularly uncompensated congestive heart failure NYHA grade 2 or more or LVEF \< 40% on any prior assessment. (Assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease). Patients with a prior LVEF \<40% will require re-evaluation prior to study entry.
• Subjects on medications that may not be safely stopped during the fasting portion of the study, or which may not be safely consumed without food.
• A history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC/Norris Comprehenseive Cancer Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Dorff TB, Groshen S, Garcia A, Shah M, Tsao-Wei D, Pham H, Cheng CW, Brandhorst S, Cohen P, Wei M, Longo V, Quinn DI. Safety and feasibility of fasting in combination with platinum-based chemotherapy. BMC Cancer. 2016 Jun 10;16:360. doi: 10.1186/s12885-016-2370-6.

  PMID: 27282289 DERIVED

MeSH Terms

Interventions

Angptl4 protein, mouse

Study Officials

• David I Quinn, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 10, 2009
• Study Start: July 9, 2009
• Primary Completion: September 1, 2024
• Study Completion: May 23, 2025
• Last Updated: June 2, 2025

Record last verified: 2025-05

Locations

US (1)